Risk factors as criteria for drain use in gastrectomy: A prospective study
- Authors:
- Published online on: June 26, 2025 https://doi.org/10.3892/mco.2025.2870
- Article Number: 75
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Copyright: © Eleftheriou et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
Abstract
In total, 60 patients were included in the prospective study, with 40 receiving a drain based on evidence‑supported, case‑based criteria. The non‑drain group exhibited lower pain scores, earlier rates of mobilization, lower levels of post-operative nausea and vomiting, and shorter hospital stays. By contrast, patients presenting with complications experienced a delayed post‑operative recovery, which may have been associated with the use of the drain. Although adverse effects are common, the application of specific criteria may aid clinical decision making. In conclusion, the present study aimed to provide a criteria‑based approach for individualising drain placement in gastrectomy. Notably, the findings of the present study are comparable with those of existing studies; thus, the suggested criteria offer a structured and reliable approach to the use of drain placement following gastrectomy in surgical practice.
Introduction
Gastric cancer is the fifth most common cancer globally, with the fifth highest rates of mortality (1). Notably, most patients with gastric cancer present with stages IB to IIIC of the disease, according to the American Joint Committee on Cancer (AJCC). At present, the gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract reconstruction (2-5). The 5-year survival rates following R0 resection vary, ranging from 89.9% for stage IB disease to 20.2% for stage IIIC disease, as reported in the 8th edition of the TNM classification (6). Due to the high morbidity rates associated with gastrectomy, research has focused on improving perioperative care and the quality of life of patients (7,8). Moreover, despite its curative intent, total gastrectomy often leads to persistent post-gastrectomy syndromes that can significantly impair short and long-term quality of life (9-11). Importantly, quality of life (HRQoL) has also been identified as an independent prognostic factor for survival, underscoring its importance in postoperative care (12,13).
Results of previous studies demonstrated that minimizing surgical intervention may be associated with improved rates of recovery (7,8,14). The Enhanced Recovery after Surgery (ERAS) guidelines offer globally recognized perioperative recommendations for various surgeries. Notably, the guidance recommends against the use of drain placement to reduce complications, such as pain, delayed mobilization and infection (8). Historically, drain placement remained a routine intervention during gastrectomy (15), with literature reporting usage rates of 57.7-62.8% (16-18). In 2014, Mortensen et al (19) introduced the ERAS guidelines for gastrectomy in gastric cancer, based on two meta-analyses (including 400 cases) and two prospective trials. Results of these studies revealed no significant differences in hospital stay, morbidity rates, mortality rates or complications between patients with and without drains (20-23). However, due to heterogeneity in surgery type and data collection, the evidence was considered insufficient.
Although the ERAS guidelines provide clear recommendations for the use of drains in surgeries such as pancreaticoduodenectomies and colectomies (24,25), their usage in gastrectomy for gastric cancer remains the topic of debate. Japanese guidelines support the routine use of drains following total gastrectomy, with removal by the fifth post-operative day (26). Results of previous studies in Japan also highlighted the prognostic value of drain contents post-gastrectomy, reinforcing this practice (15,27-31). By contrast, Western guidelines, such as those from the American College of Surgeons, advise against routine drain use, suggesting placement only in exceptional cases (32). This conflicting evidence may lead to uncertainty regarding drain use in gastrectomy, resulting in limited adherence to ERAS recommendations in Western practices (33,34).
The present prospective, non-randomized, controlled clinical trial aimed to individualize drain use following gastrectomy for the treatment of gastric cancer. The tailored approach described in the present study is based on criteria developed using previous literature, including established risk factors for post-operative complications. Significantly, the objective of the study was not to assess the benefit of drains themselves, but rather to determine whether these predefined clinical criteria can effectively guide the decision to place a drain during open total gastrectomy. To the best of our knowledge, the present study is the first to propose specific criteria addressing routine prophylactic drain use in total gastrectomy, aiming to provide a structured framework for clinical decision making in high-volume centers.
Materials and methods
Study design
The DRains After Gastrectomy (DRAG) trial (Clinical Trials.gov NCT 04288661) was a prospective, non-randomized, controlled clinical trial involving patients diagnosed with gastric or esophagogastric junctional neoplasm. All surgeries were performed by experienced Foregut Surgeons in The University Surgical Department at Hippocration General Hospital in Athens, Greece, a leading referral centre for upper gastrointestinal tract diseases. Patients underwent open total gastrectomy with D2 lymph node dissection, followed by Roux-en-Y gastrointestinal tract reconstruction. This was performed in accordance with a pre-defined, ERAS-compliant perioperative departmental protocol. The study design was conducted according to the following sequence: i) A literature review was carried out to identify commonly reported risk factors for major intra-abdominal complications following total gastrectomy; ii) The most consistently cited risk factors were selected to form the basis for the drain placement criteria; iii) Eligible patients were screened according to predefined preoperative and intraoperative criteria; iv) The final decision regarding drain placement was made intraoperatively-after completion of the resection and reconstruction, and immediately prior to abdominal wall closure-based on the selected criteria; v) All patients were followed for 30 days postoperatively, in line with the institutional monitoring protocol.
As aforementioned, the first step involved a comprehensive review of the literature, focused on the use of gastrectomy for the treatment of gastric cancer, and on the identification of risk factors associated with post-operative complications, such as esophagojejunal anastomotic leak or bleeding. The present review included 11 retrospective studies and two randomized controlled trials, and these highlighted numerous risk factors associated with the aforementioned complications. Of these, the most consistently reported factors were selected for subsequent analyses. The following criteria were suggested for the placement of a drain, as the presence of these risk factors signified an increased risk of post-operative complications (15,35-47): i) Chronic cardiopulmonary disease; ii) chronic oral steroid use (≥5 mg/day prednisone equivalent for >1 month); iii) intraoperative hemodynamic instability requiring vasopressors; iv) intraoperative blood loss exceeding 250 ml (mean amount of estimated blood loss in all included studies), referring to intra-operative non-traumatic, non-vascular blood loss; v) vessel injury involving the celiac axis or the associated branches; vi) injury to adjacent structures, such as the pancreas, spleen or duodenum; vii) tension at the anastomosis, or the requirement for anastomosis reconstruction; and viii) concerns regarding the integrity of the duodenal stump, particularly due to potential staple misfiring or compromised tissue quality.
All patients that met the eligibility criteria underwent pre-operative evaluations, including clinical examinations, blood tests, imaging studies and consultations with specialist clinicians. The eligibility criteria included the following: Histologically confirmed gastric adenocarcinoma; planned open total gastrectomy with D2 lymphadenectomy; no evidence of distant metastasis (M1); absence of massive ascites or severe cachexia; no unplanned organ resections; no severe cardiovascular, respiratory, renal, hepatic, or psychiatric conditions; not currently enrolled in another clinical trial; and no contraindications such as pregnancy or poor compliance with clinical protocols. Intraoperative criteria that ruled out eligibility included findings of unresectable or metastatic disease and cases requiring conversion to subtotal gastrectomy.
Intra-operatively, all dissections were carried out with an ultrasonic vibration scalpel to minimise blood loss. Saline was used for irrigating the surgical field, and volume was monitored and excluded from the total calculated blood loss. Notably, the protocol followed by the University Surgical Department at Hippocration General Hospital does not routinely incorporate exploratory laparoscopy or peritoneal cytology. In some cases, high procedural complexity may necessitate lymphadenectomy beyond a standard D2 dissection (48). However, to maintain uniformity, only patients undergoing D2 gastrectomy were included in the present study.
Final allocation to the drain or non-drain group was made at the end of the procedure and prior to abdominal wall closure. The decision for drain was based on the aforementioned criteria. The patients for whom drain placement was decided, received a standard 10-mm (~30 Fr) silicone tube drain near the esophagojejunal anastomosis (Shanghai International Holding Corp GmbH). By contrast, no drain was placed in the patients who did not meet the criteria. A CONSORT flowchart illustrating patient enrolment, exclusion, and group allocation is provided in Fig. 1.
According to the departmental protocol, patients were gradually mobilized directly following surgery, when feasible. At 48 and 72 h post-surgery, an oral gastrografin fluoroscopy study was performed for each patient, for the detection of early anastomotic leaks. Following a routine radiological study, patients were initiated on a liquid diet, which was subsequently advanced to pureed food on the fourth post-operative day, and a soft diet on the fifth post-operative day. In the drain group, drains were monitored daily for 24-h output volume and fluid characteristics, including amylase and bilirubin concentrations. They were removed from patients in the drain group on the fifth post-operative day, when drainage volume was <50 ml within the preceding 48 h. Drain output was considered excessive if the volume exceeded 100 ml on postoperative day five (18,26) or if the drain fluid amylase level was greater than three times the upper limit of normal serum amylase on or after postoperative day three, consistent with the definition of a postoperative pancreatic fistula (49). Patients were discharged on the fifth post-operative day when no complications were observed.
Drain and non-drain groups were compared within the following cohorts: i) The overall study population; ii) patients with complications; and iii) patients without complications.
Primary outcomes were as follows: i) Pain level assessment during the first 5 post-operative days, using the Visual Analog Scale (VAS). Notably, the VAS is a 10-point scale, with 0 representing no pain and 10 indicating the highest level of pain. A score of >7 is considered high (50); ii) post-operative nausea and vomiting (PONV) within the first 5 post-operative days; iii) initiation of feeding, carried out between 48 and 72 h post-surgery. According to the ERAS-compliant institutional protocol, initiation of feeding beyond the third post-operative day is considered delayed; iv) post-operative bowel mobilization, primarily measured by the time to the first passage of flatus; v) patient mobilization, following a specific post-operative mobilization schedule for each day. Failure to meet the specific criteria was indicative of a delay in mobilization; and vi) length of hospital stay, referring to the time from the day of the operation to the day of discharge.
Secondary outcomes included: i) mortality, referring to death occurring within 30 days post-surgery; ii) readmissions due to surgical complications, occurring within 30 days post-surgery, and iii) reoperations due to surgical complications, occurring within 30 days post-surgery.
The present study was conducted in accordance with the principles outlined in the Declaration of Helsinki (51) and the Guidelines of Good Clinical Practice (52). The final study protocol and the informed consent form for participant inclusion were approved by the Institutional Review Board of Hippocration General Hospital (approval no. 1678/31-01-2020; Athens, Greece). The IRB also conducted regular assessments as required, to ensure ongoing compliance with lawful medical practice throughout the trial.
Statistical analysis
Statistical analysis was performed using R software (version, 4.3.0; R foundation for Statistical Computing). Descriptive statistics for quantitative data included descriptive characteristics, and these were expressed as the median and minimum/maximum values and quartile 1 (Q1) to quartile 3 (Q3) range, and/or for completeness reasons the mean ± standard deviation (SD). Descriptive statistics for qualitative data were expressed as the frequency of occurrence and the relevant percentage. Comparisons were performed between patients with drainage and those without drainage, and additional analyses were performed between patients with and without complications. Qualitative data were analysed using Chi-squared and Fisher's exact tests when required and quantitative data were analysed using the Mann Whitney U test, as data normality was not always confirmed (via the Shapiro Wilk test). P<0.05 was considered to indicate a statistically significant difference. For time to event analysis, that is to visualize and report time to gut mobilization and days of hospitalization, the Kaplan-Meier estimator was applied.
To address potential confounding and strengthen causal inference between study groups, a propensity score matching (PSM) approach was applied using R version 4.4.0(53). The binary clinical covariates were blood loss, vessel damage, anastomosis, stump and respiratory issues, the criterion of adjacent structures was not involved since none of the patients had such issues in addition drainage volume was also not possible to account as only two patients had abnormal drainage volume. Eventually, the application of a drain was modelled using logistic regression to estimate the propensity scores and matching was performed using 1:1 nearest neighbour matching without replacement through the MatchIt package (54) especially developed for the R environment. Covariate balance was evaluated using standardized mean differences. Moreover, to explore potential impact of possible confounders, a Rosenbaum sensitivity analysis was conducted using the rbounds package (55). Finally, subgroup analysis was performed between patients with and without a drain, separately for the patients that had complications and those who did not experience such complications.
Results
Comparison of the overall study population
The present study was conducted from February 2020 to March 2023. Of the 60 eligible participants, 40 were assigned to the drain group, while 20 were included in the non-drain group, as per the aforementioned criteria. The mean age of patients was 71±9.6 years. Pre-operative histological diagnosis primarily identified intestinal-type gastric cancer in 46.6% of cases, with the body of the stomach being the most common location of observed lesions (43.3%). In addition, 25% (n=15) of patients had undergone pre-operative chemotherapy due to nodal positivity (N≥1) at diagnosis, or due to unresectability observed during exploratory laparotomy (Table I). As there were no patients on chronic steroids or patients that developed intra-operative hemodynamic instability, these factors were not included in the results. Results of the present study revealed no statistically significant differences in pre-operative characteristics between the drain and non-drain groups (Table II).
 | Table IIComparison of demographics, and preoperative and intraoperative characteristics between the two groups. |
The mean duration of gastrectomy was 197±37 min. Blood transfusion was required in 13.3% of patients, and 8.3% received fresh frozen plasma (FFP) only. The most common intra-operative indications for drain placement were significant blood loss (33.3%; n=20) and tension at the anastomosis site (18.3%; n=11). Further details on intra-operative characteristics are provided in Table I. Regarding age distribution, Table II shows no statistically significant difference between the two groups: the median age was 73.5 years (IQR: 63-78) in the drain group and 73 years (IQR: 66.5-77.5) in the non-drain group (P=0.8138). No other statistically significant differences were observed when comparing intra-operative characteristics between the two groups (Table II).
Post-operatively, ~56% (n=34) of patients reported severe pain during the first 5 days post-surgery. Results of the present study also revealed that high VAS scores (>7) were significantly less frequent in the non-drain group (15%; n=3) when compared with the drain group (77.5%; n=31; P<0.0001; Fig. 2).
PONV was common in the overall study population, affecting 48.3% (n=29) of patients. Significant differences were observed between groups, with a lower incidence of PONV in the non-drain group (25%; n=5) compared with the drain group (60%; n=24; P=0.0142). Thus, there was a ~5X higher risk of PONV in the drain group [odds ratio (OR), 0.22].
Surgical site infections (SSI) were observed in 12 patients (20%), with no statistically significant difference between the drain and non-drain groups.
Timely mobilization was impeded in 37% (n=22) of patients in the overall study population. Delays in mobilization were notably less frequent in the non-drain group, occurring in only 10% (n=2) of patients, compared with 50% (n=20) in the drain group (P=0.0038). Notably, these results were statistically significant.
In 28.3% of patients (n=17), feeding initiation was delayed, despite the recommendation that feeding should be initiated 48-72 h post-surgery. Notably, the delay in feeding initiation was less common in the non-drain group, occurring in 10% (n=2) of patients, compared with 37.5% (n=15) in the drain group (P=0.0340). These results were statistically significant.
Gut motility resumed at a mean of 3.58±1 days, as illustrated by the Kaplan-Meier plot (Fig. 3). The initiation of bowel movement occurred significantly earlier in the non-drain group, with a median time of 3 days, compared with 4 days in the drain group (P=0.0142).
Intra-abdominal complications, Clavien-Dindo ≥II (56,57) occurred in 15% (n=9) of patients, accounting for 10% (n=2) of the non-drain group and 17.5% (n=7) of the drain group. Notably, there was no statistically significant difference between the two groups.
Among the intra-abdominal complications observed, the most common was esophagojejunal anastomotic leak, affecting four patients in the drain group. In total, two patients required reoperation with hybrid intra-operative stent suturing (58), one patient received endoscopic stenting, and one patient succumbed during the study period. The second most common complication was post-operative bleeding, occurring in two patients. Notably, one patient experienced bleeding on Day 0, and bleeding was evident in the drain. This patient required reoperation. In addition, one patient experienced delayed bleeding on Day 9, and this was managed non-surgically. A duodenal stump leak was identified in one patient via computed tomography on Day 7, and this patient was managed conservatively. Necrotizing pancreatitis developed in one patient from the non-drain group due to a pancreatic leak detected on Day 3, and this led to reoperation. Notably, this patient died during the study period. Post-operative ileus requiring nasogastric tube placement occurred in one patient. A detailed summary of the aforementioned findings is provided in Table I.
Extra-abdominal complications occurred in 8.3% (n=5) of patients, comprising 5% (n=2) of the non-drain group and 10% (n=3) of the drain group. All extra-abdominal complications involved the respiratory system, including three cases of atelectasis, one pleural effusion and one case of respiratory failure in a patient who also experienced the pancreatic leak. However, there was no statistically significant difference between the drain and non-drain groups.
The mean length of hospital stay was 9.5±9 days (Fig. 3). Patients in the non-drain group experienced a significantly shorter length of stay with a median of 5 days, compared with 7 days in the drain group (P=0.0001).
The majority of cases were classified as stages 1B (16.7%), 2A (26.7%) and 2B (20.0%) according to the AJCC. Comparisons between the drain and non-drain groups revealed no statistically significant differences in the distribution of AJCC stages.
In the overall study population, the 30-day post-operative outcomes included a 5% mortality rate, an 8.33% readmission rate and a 10% reoperation rate we reviewed the ages of the patients who died compared with those who survived. The mean age of deceased patients was 69.7 years (76, 66 and 67 years, one female and two males), while the mean age of survivors was 71.1 years. This indicates that there was no statistically significant association (P>0.05) between age and mortality within our cohort. No other statistically significant differences were observed between the drain and non-drain groups.
Of the 40 patients who received a drain, 4 (10%) exhibited excessive drain output by postoperative day five, and 5 (12.5%) met the criteria for postoperative pancreatic fistula. Among those with excessive output, 2 patients-who also had a pancreatic fistula-developed intra-abdominal complications. All comparisons made between the two groups, including demographic, histological and intra-operative characteristics are summarized in Fig. 2.
Propensity score matching was feasible for 20 cases from each group, the covariate balance as measured via standardized mean differences had values as follows: blood loss: 1.4, vessel damage: 0.38, anastomosis: 0.12, stump: 0.57, respiratory issues: 0.57 indicative for not perfect balance between the two categories, however we applied additional sensitivity analysis.
The Rosenbaum sensitivity test evaluated how sensitive the outcomes of the matched data were to a potential presence of unmeasured confounding. Under the assumption of no hidden bias, Gamma=1 the test yielded a P-value of 0.0899 (marginally non-significant) suggesting that, in the absence of unmeasured confounding, there is weak evidence that the treatment effect differs from zero. At increased Gamma=2, the bounds of the P-value were in the range 0.0134 to 0.2635, meaning that if there is an unmeasured factor that doubles the odds of being assigned to non-drain group, the true P-value could vary from being statistically significant (0.0134) to clearly non-significant (0.2635). In summary, the sensitivity analysis indicated that there results moderately sensitive to hidden bias.
Comparison of patients with intra-abdominal complications
Of the 60 eligible patients, nine (15%) experienced intra-abdominal complications, classified as Clavien-Dindo ≥II. In the drain group, complications included one grade IIIa, three grade IIIb, two grade II and one grade IV. In the non-drain group, complications included one grade V and one grade II.
Patients with complications were compared with those without complications to identify perioperative factors that may influence or be influenced by complications. Fisher's exact test was used for the analysis of categorical data. Results of the present study revealed no significant differences in pre-operative characteristics between the two groups (Table III and Fig. 4).
| Table IIIPre- and intra-operative characteristics among patients with and without intra-operative complications. |
Intra-operatively, although FFP transfusion was not initially considered a potential risk factor for developing intra-abdominal complications, we later observed that patients who developed such complications had received FFP transfusion more frequently than those without complications (P=0.0208; OR, 12.3). In addition, vessel injury was the most common indication for drain placement (P=0.05; OR, 14.3; Table III).
The analysis of post-operative characteristics revealed differences between patients with and without intra-abdominal complications. Notably, differences were observed in oral contrast, SSIs, patient mobilization delays, extra-abdominal complications, length of hospital stay (LOS), readmissions and reoperations (Fig. 4).
As aforementioned, nine patients experienced intra-abdominal complications, with seven patients included in the drain group and two patients included in the non-drain group. The most common complications included anastomotic leak and bleeding, and these significantly affected the LOS and rates of reoperation. The median day of complication detection was 5.8 (range, 1-11; Table SI). Although the number of cases in this subgroup is relatively small, the statistical analysis was performed to ensure completeness and the outcomes revealed no statistically significant differences in the detection of anastomotic leaks, post-operative day of complication detection, diagnosis based on drain content, hospitalization duration, reoperation rates or mortality between the two groups.
Drains were closely monitored for signs suggestive of intra-abdominal complications. Notably, four patients with complications were identified through drain content analysis, while three were detected based on clinical presentation and blood tests. A comparison between patients diagnosed via drain analysis and those diagnosed through other methods revealed no significant differences in terms of detection method, post-operative day of diagnosis, LOS or rates of mortality (Table SII).
Comparison of patients without intra-abdominal complications
A total of 51 patients did not exhibit any intra-abdominal complications. A comparative analysis was performed within this subgroup to determine whether non-abdominal adverse effects were more prevalent in the drain or non-drain group. When comparing the pre- and intra-operative characteristics of each group, no statistical significance was observed (Table SIII). Results of the present study revealed that a blood loss of >250 ml was the most common indication for drain placement in this group (P<0.001).
Moreover, statistically significant differences in pain score, delay of patient mobilization, oral feeding delay, initiation of gut motility and LOS were observed between groups post-surgery (Table IV).
Discussion
The use of drains following elective total D2 gastrectomy remains a topic of debate in surgical practice. The ERAS guidelines recommend against the use of drains, with reduced recovery periods and hospital stays, and an earlier return to daily activities when their use is avoided (7,8,19,24,25,59). Yet, compliance with the aforementioned guidelines varies globally, with the use of smaller drainage tubes being supported in some practices. However, reductions in drain size exerted minimal impact on psychological outcomes or the rates of SSIs (16,60,61). Notably, the present study aimed to provide specific criteria to support clinical decision making on drain placement following total gastrectomy for the treatment of gastric cancer.
Expertise is a critical factor in the present study, as it influences the quality of care provided. In this context, an experienced surgeon in a high-volume centre plays a key role in assessing post-operative risk and tailoring drain placement (60,62).
Results of the present study revealed no significant pre-operative or demographic differences between patients with and without drains across all three groups. The absence of statistically significant differences between the drain and non-drain groups indicated that the cohorts were comparable, enhancing the reliability and robustness of the present statistical analyses. While the results of the present study may further the current understanding of the use of drains, larger, multi-centre studies with more diverse populations are required, to provide more definitive conclusions and validate the applicability of these criteria in different clinical settings.
Results of the present study revealed that patients who required FFP transfusion during surgery exhibited a higher incidence of complications, including anastomotic leaks. As it has been previously reported, packed red blood cell transfusions may adversely affect post-operative outcomes (63-65). Previous studies suggest that FFP transfusion may exert immunosuppressive effects through several mechanisms. These include downregulation of proinflammatory cytokines such as TNF-α and upregulation of anti-inflammatory mediators such as IL-10, resulting in attenuated systemic inflammatory responses-reflected by lower C-reactive protein levels and altered leukocyte counts. Additionally, soluble HLA class I molecules and fibroblast-derived ligands present in stored plasma can impair natural killer cell cytotoxicity and suppress T-cell proliferation, further contributing to immune modulation (63,66). Thus, FFP transfusion should be considered as an intra-operative risk factor. Future studies could include measurement of systemic inflammatory markers, such as IL-6 and CRP, to improve elucidation of the relationship between drain use and immunomodulatory effects.
In the present study, vessel injury was identified as a significant risk factor for post-operative complications. Thus, vessel injury should be considered when deciding on drain placement during gastrectomy.
By contrast, blood loss exceeding 250 ml was the primary factor for selecting drain placement in patients who exhibited no intra-abdominal complications. Notably, 250 ml was selected as the minimum mean value based on the results of previous studies (15,42-46,67-71). Results of previous studies demonstrated an association between post-operative intra-abdominal complications and non-vascular blood loss that does not require transfusion. Fibrinolytic and inflammatory pathway activation may play a role in non-vascular blood loss (67-71). However, there were no detailed methods for estimating blood loss in each study, which may have led to discrepancies between the reported and actual values associated with intra-abdominal complications.
Moreover, results of previous studies highlighted multiple risk factors associated with post-operative complications, such as advanced age (>65 years), male sex, diffuse tumor histology, extensive lymphadenectomy, extended surgery duration and impaired blood supply (35-40). However, the literature is often based on retrospective studies with variation in the type of gastric surgery, indication and patient cohort. In the present study, the aforementioned factors were not statistically significant; thus, further investigations are required.
In the present study, the gastrografin swallow test was performed 48-72 h post-surgery, and the results demonstrated a sensitivity of 50%. This oral contrast study is routinely performed on or after the fifth following total gastrectomy. However, results of previous studies revealed that 46.6-63.6% (72-75) of esophagojejunal anastomotic leaks occur prior to the scheduled contrast study. Thus, the oral contrast study was conducted 48-72 h following surgery in the present study, to determine the potential for improved sensitivity in anastomotic leak detection. However, the results of the present study were comparable with those previously obtained, highlighting the low levels of sensitivity (20-60%) of this technique in confirming esophagojejunal anastomotic integrity (72-75).
In the present study, pain was determined using VAS score. The results revealed marginal levels of statistical significance between the drain and non-drain groups when complications were present. However, a significant difference was observed in patients without complications, suggesting that drain placement may be avoidable in these cases. Results of the present study were comparable with those previously obtained, further highlighting that drains may negatively impact the levels of post-operative pain (21,22,59).
Moreover, results of the present study revealed a significant difference in PONV between the drain and non-drain groups in the overall study population. These findings supported the rationale for the selective use of drains, limiting them to high-risk patients, as per the suggested criteria. Previous studies focused on drain-related PONV in bariatric surgery (76,77); however, studies focused on the use of drains in gastrectomy for the treatment of gastric cancer are limited. The use of drains should be carefully considered, as PONV may contribute to prolonged hospital stays.
Results of the present study also highlighted that there was no statistically significant difference in SSIs between the drain and non-drain groups. However, in patients with post-operative complications, the drain group exhibited a significantly higher rate of SSI, which is comparable with the results obtained in previous studies. No statistically significant differences were observed between drain and non-drain groups in patients without complications. Notably, the potential association between drains and SSIs remains to be fully elucidated, with several studies reporting no association (18,22,23,78), and others suggesting that retro-grade bacterial contamination or leakage of protein-rich ascitic fluid may play a role in SSI development (79). Thus, the use of drains in patients with complications should be carefully considered to minimize the risk of SSIs.
Results of the present study revealed that extra-abdominal complications, limited to respiratory tract infections in the present study, were more prevalent in patients with drains when intra-abdominal complications occurred. However, no statistically significant difference was observed when comparing patients without complications. Results of a previous study demonstrated that drain-induced pain may be associated with micro-atelectases and subsequent respiratory tract infections (60), and a further study revealed that drain placement may facilitate the dissemination of pathogens (16,79). By contrast, numerous retrospective studies focused on total and subtotal gastrectomy revealed no statistically significant differences in the incidence of pulmonary-related complications between groups that received post-operative drains and those that did not (18,22). Conflicting results highlight the requirement for further investigations that focus on the role of post-operative drains in pulmonary events.
Results of the present study also revealed that drain placement in patients with no intra-abdominal complications was associated with delays in mobilization, oral feeding and gastrointestinal tract motility. However, statistical significance was marginal when compared with patients with intra-abdominal complications. Thus, delays in mobilization, oral feeding and gastrointestinal tract motility may be associated with the specific complication, rather than with the presence of a drain. By contrast, the drain was considered the primary contributing factor in the absence of complications. Previous studies focused on the impact of drains on mobilization and gastrointestinal function demonstrate conflicting results, with some studies reporting no significant differences between drain and non-drain groups, and further studies demonstrating that drains may hinder recovery (15,16,18,20,59).
In the present study, the use of drains significantly impacted the LOS. As expected, patients who experienced delays in mobilization, dietary resumption and restoration of gastrointestinal motility were less likely to be discharged in a timely manner. These results are comparable with those obtained previously (20-23,59,80). Drains may delay mobilization due to a fear of dislodgement or pain, leading to prolonged bowel motility recovery and feeding initiation. Thus, individualized drain use is suggested.
Results of the present study also indicated that the number of readmissions and reoperations was highest in patients in the drain group who developed intraabdominal complications. Notably, results of a previous study also revealed that the number of reoperations may be associated with complications (15); however, evidence for the potential association between readmissions and complications is conflicting (80,81). The results of two meta-analyses demonstrated higher readmission rates in non-drain groups, primarily due to undetected complications during the initial hospital stay and a poor ERAS compliance. Thus, low rates of readmission may be attributed to the implementation of the selected criteria, which were systematically applied to identify patients in whom omitting the perianastomotic drain was considered both appropriate and safe.
In the present study, the rates of mortality differed between patients with and without intra-abdominal complications; however, the levels of statistical significance were marginal. Moreover, no statistically significant difference in mortality rates was observed between the drain and non-drain groups. Studies focused on the rates of mortality in these groups are limited, with two previous studies reporting that there were no statistically significant differences in mortality between the drain and non-drain groups (22,23).
In summary, the present study demonstrated that a criteria-based approach may aid in standardizing drain placement in gastrectomy. The use of pre-defined criteria ensures a more consistent decision-making process; thus, reducing variability in surgical practice. While the study was not designed to evaluate the benefit of drain use itself, the presence of statistically significant differences between certain subgroups supports the clinical relevance of a selective approach. These criteria could be considered for application in routine clinical settings.
The present study exhibits numerous limitations. For example, the sample size included in the present study was small, and this was largely due to constraints imposed by the coronavirus-19 pandemic when conducted. The small sample size may have introduced selection bias, reduced statistical power and limiting the generalizability of the findings, which could have affected the observed statistical significance levels. Moreover, the present study was not designed to assess the clinical benefit of drain placement itself, but rather to evaluate the feasibility and relevance of predefined criteria guiding their use in open total gastrectomy. The small sample size further limits any conclusions regarding efficacy of the drains and reinforces the need for cautious interpretation, as for example the role of the drain in the intra-abdominal complication. Thus, further investigations with increased sample sizes are required. Additionally, the present study focused on patients undergoing open D2 gastrectomy, which may have led to selection bias. Notably, a focus on these patients may have led to the exclusion of more complex cases requiring extended lymphadenectomy, subtotal gastrectomy, or laparoscopic approach restricting the applicability of the results to broader populations. In addition, an absence of randomization and blinding in the present study introduces possible selection bias, especially in subjective outcomes (for example, pain, PONV). However, due to the specific design and objectives of the study, randomization was not feasible. As previously outlined, the literature presents conflicting evidence on the use of prophylactic drains, with opposing perspectives supported by multiple randomized trials and studies (15-23). However, none of the trials incorporated predefined criteria for drain placement. Future studies that will include criteria on drain insertion should adopt RCTs with strict baseline matching. Finally, our study analysed some patients' parameters collectively, potentially obscuring differences among subgroups. Future larger studies could consider patients' tumor stage, surgical complexity, and preoperative chemotherapy status.
In conclusion, debate is ongoing regarding the use of drains in total gastrectomy. While national guidelines provide recommendations for their use in clinical practice, decision-making is the responsibility of the clinician. The present study proposed evidence-based criteria that may lead to standardization of drain usage, providing a practical decision-making tool that may be applied in cases with and without complications.
To the best of our knowledge, the present study is the first prospective study to implement literature-based criteria for drain use in gastrectomy for the treatment of gastric cancer. Results of the present study provide a novel theoretical basis for drain use, and further investigations should focus on refining and expanding the outlined criteria.
Supplementary Material
Statistical analysis outcomes for the subgroup of patients with intra-abdominal complications.
Statistical analysis of intra-abdominal complications: drain content as a differentiation factor.
Pre- and intra-operative characteristics among patients without intra-abdominal complications.
Acknowledgements
Not applicable.
Funding
Funding: No funding was received.
Availability of data and materials
The data generated in the present study may be found in the Clinical Trial.gov under accession number NCT04288661 or at the following URL: https://clinicaltrials.gov/study/NCT04288661?term=drag&rank=1.
Authors' contributions
ME served as the principal investigator of the study, contributing to its conception and design, data acquisition, interpretation, and manuscript drafting. MD provided data interpretation and analysis, as well as critical revisions to the manuscript draft. AP and DK conducted data statistical analysis and had substantial contribution to the design of the manuscript. DA contributed to data interpretation and critical manuscript revisions. DT was the study sponsor and surgical lead for all procedures; alongside ME, he contributed to the study's conception and design. TT was responsible for data acquisition and analysis. GZ and KT contributed to data analysis and interpretation along with critical revisions, ensuring the intellectual rigor of the manuscript. All authors read and approved the final version of the manuscript. Additionally, ME, DT and TT have agreed to be accountable for all aspects of the work, so that any questions relating to research integrity or scientific accuracy in any part of the study are appropriately investigated and resolved. ME, DT and TT confirm the authenticity of all the raw data.
Ethics approval and consent to participate
The present study was conducted in accordance with the principles outlined in the Helsinki Declaration of Human Rights and with the Guidelines of Good Clinical Practice. The final study protocol received approval from the Institutional Review Board (IRB) of Hippocration General Hospital (approval no. 1678/31-01-2020; Athens Greece). Informed consent was obtained from all patients involved in the study, both for the study participation and the results' publication.
Patient consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests
Use of artificial intelligence tools
During the preparation of this work, artificial intelligence tools were used to improve the readability and language of the manuscript, and subsequently, the authors revised and edited the content produced by the artificial intelligence tools as necessary, taking full responsibility for the ultimate content of the present manuscript.
References
|
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I and Jemal A: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 74:229–263. 2024.PubMed/NCBI View Article : Google Scholar | |
|
Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A and Smyth EC: ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 33:1005–1020. 2022.PubMed/NCBI View Article : Google Scholar | |
|
Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, et al: Gastric cancer, version 2.2022, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 20:167–192. 2022.PubMed/NCBI View Article : Google Scholar | |
|
Huang N, He HW, He YY, Gu W, Xu MJ and Liu L: Xiaotan Sanjie recipe, a compound Chinese herbal medicine, inhibits gastric cancer metastasis by regulating GnT-V-mediated E-cadherin glycosylation. J Integr Med. 21:561–574. 2023.PubMed/NCBI View Article : Google Scholar | |
|
Yan L, Li W, Chen F, Wang J, Chen J, Chen Y and Ye W: Inflammation as a mediator of microbiome Dysbiosis-associated DNA methylation changes in gastric premalignant lesions. Phenomics. 3:496–501. 2023.PubMed/NCBI View Article : Google Scholar | |
|
Kim SG, Seo HS, Lee HH, Song KY and Park CH: Comparison of the Differences in Survival Rates between the 7th and 8th Editions of the AJCC TNM staging system for gastric adenocarcinoma: A Single-institution study of 5,507 patients in Korea. J Gastric Cancer. 17:212–219. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Ljungqvist O, Young-Fadok T and Demartines N: The history of enhanced recovery after surgery and the ERAS society. J Laparoendosc Adv Surg Tech A. 27:860–862. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Tanious MK, Ljungqvist O and Urman RD: Enhanced recovery after surgery: History, evolution, guidelines, and future directions. Int Anesthesiol Clin. 55:1–11. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Park KB, Park JY, Lee SS, Chung HY and Kwon OK: Chronological changes in quality of life and body composition after gastrectomy for locally advanced gastric cancer. Ann Surg Treat Res. 98:262–269. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Ikeda M, Yoshida M, Mitsumori N, Etoh T, Shibata C, Terashima M, Fujita J, Tanabe K, Takiguchi N, Oshio A and Nakada K: Assessing optimal Roux-en-Y reconstruction technique after total gastrectomy using the Postgastrectomy Syndrome Assessment Scale-45. World J Clin Oncol. 13:376–387. 2022.PubMed/NCBI View Article : Google Scholar | |
|
Pinheiro RN, Mucci S, Zanatto RM, Picanço Junior OM, Bottino AAG, Fontoura RP and Lopes Filho GJ: Quality of life as a fundamental outcome after curative intent gastrectomy for adenocarcinoma: Lessons learned from patients. J Gastrointest Oncol. 10:989–998. 2019.PubMed/NCBI View Article : Google Scholar | |
|
Husson O, de Rooij BH, Kieffer J, Oerlemans S, Mols F, Aaronson NK, van der Graaf WTA and van de Poll-Franse LV: The EORTC QLQ-C30 summary score as prognostic factor for survival of patients with cancer in the ‘Real-World’: Results from the Population-Based PROFILES registry. Oncologist. 25:e722–e732. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Hu Y and Zaydfudim VM: Quality of life after curative resection for gastric cancer: Survey metrics and implications of surgical technique. J Surg Re. 251:168–179. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Kehlet H and Mogensen T: Hospital stay of 2 days after open sigmoidectomy with a multimodal rehabilitation programme. Br J Surg. 86:227–230. 1999.PubMed/NCBI View Article : Google Scholar | |
|
Shimoike N, Akagawa S, Yagi D, Sakaguchi M, Tokoro Y, Nakao E, Tamura T, Fujii Y, Mochida Y, Umemoto Y, et al: Laparoscopic gastrectomy with and without prophylactic drains in gastric cancer: A propensity score-matched analysis. World J Surg Oncol. 17(144)2019.PubMed/NCBI View Article : Google Scholar | |
|
Hirahara N, Matsubara T, Hayashi H, Takai K, Fujii Y and Tajima Y: Significance of prophylactic intra-abdominal drain placement after laparoscopic distal gastrectomy for gastric cancer. World J Surg Oncol. 13(181)2015.PubMed/NCBI View Article : Google Scholar | |
|
Lee J, Choi YY, An JY, Seo SH, Kim DW, Seo YB, Nakagawa M, Li S, Cheong JH, Hyung WJ, et al: Do all patients require prophylactic drainage after gastrectomy for gastric cancer? The Experience of a High-Volume Center. Ann Surg Oncol. 22:3929–3937. 2015.PubMed/NCBI View Article : Google Scholar | |
|
Kumar M, Yang SB, Jaiswal VK, Shah JN, Shreshtha M and Gongal R: Is prophylactic placement of drains necessary after subtotal gastrectomy? World J Gastroenterol. 13:3738–3741. 2007.PubMed/NCBI View Article : Google Scholar | |
|
Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM and Lassen K: Enhanced Recovery After Surgery (ERAS®) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Br J Surg. 101:1209–1229. 2014.PubMed/NCBI View Article : Google Scholar | |
|
Alvarez Uslar R, Molina H, Torres O and Cancino A: Total gastrectomy with or without abdominal drains. A prospective randomized trial. Rev Esp Enferm Dig. 97:562–569. 2005.PubMed/NCBI View Article : Google Scholar | |
|
Kim J, Lee J, Hyung WJ, Cheong JH, Chen J, Choi SH and Noh SH: Gastric cancer surgery without drains: A prospective randomized trial. J Gastrointest Surg. 8:727–732. 2004.PubMed/NCBI View Article : Google Scholar | |
|
Liu HP, Zhang YC, Zhang YL, Yin LN and Wang J: Drain versus no-drain after gastrectomy for patients with advanced gastric cancer: Systematic review and meta-analysis. Dig Surg. 28:178–189. 2011.PubMed/NCBI View Article : Google Scholar | |
|
Wang Z, Chen J, Su K and Dong Z: Abdominal drainage versus no drainage post gastrectomy for gastric cancer. Cochrane Database Syst Rev: CD008788, 2011. | |
|
Mahendran R, Tewari M, Dixit VK and Shukla HS: Enhanced recovery after surgery protocol enhances early postoperative recovery after pancreaticoduodenectomy. Hepatobiliary Pancreat Dis Int. 18:188–193. 2019.PubMed/NCBI View Article : Google Scholar | |
|
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, et al: Guidelines for perioperative care in elective colorectal surgery: Enhanced recovery after surgery (ERAS®) society recommendations: 2018. World J Surg. 43:659–695. 2019.PubMed/NCBI View Article : Google Scholar | |
|
Lim SY, Kang JH, Jung MR, Ryu SY and Jeong O: Abdominal drainage in the prevention and management of major Intra-abdominal complications after total gastrectomy for gastric carcinoma. J Gastric Cancer. 20:376–384. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Kanda M, Fujiwara M, Tanaka C, Kobayashi D, Iwata N, Mizuno A, Yamada S, Fujii T, Nakayama G, Sugimoto H, et al: Predictive value of drain amylase content for peripancreatic inflammatory fluid collections after laparoscopic (assisted) distal gastrectomy. Surg Endosc. 30:4353–4362. 2016.PubMed/NCBI View Article : Google Scholar | |
|
Taniguchi Y, Kurokawa Y, Mikami J, Tanaka K, Miyazaki Y, Makino T, Takahashi T, Yamasaki M, Nakajima K, Takiguchi S, et al: Amylase concentration in drainage fluid as a predictive factor for severe postoperative pancreatic fistula in patients with gastric cancer. Surg Today. 47:1378–1383. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Kamiya S, Hiki N, Kumagai K, Honda M, Nunobe S, Ohashi M, Sano T and Yamaguchi T: Two-point measurement of amylase in drainage fluid predicts severe postoperative pancreatic fistula after gastric cancer surgery. Gastric Cancer. 21:871–878. 2018.PubMed/NCBI View Article : Google Scholar | |
|
Kobayashi D, Iwata N, Tanaka C, Kanda M, Yamada S, Nakayama G, Fujii T, Koike M, Fujiwara M and Kodera Y: Factors related to occurrence and aggravation of pancreatic fistula after radical gastrectomy for gastric cancer. J Surg Oncol. 112:381–386. 2015.PubMed/NCBI View Article : Google Scholar | |
|
Yamagata Y, Yoshikawa T, Yura M, Otsuki S, Morita S, Katai H and Nishida T: Current status of the ‘enhanced recovery after surgery’ program in gastric cancer surgery. Ann Gastroenterol Surg. 3:231–238. 2019.PubMed/NCBI View Article : Google Scholar | |
|
Surgeons ACo: American College of Surgeons' Standards for Gastric Cancer Surgery 2021 [15/10/2024]. Available from: https://decisionpoint.medscape.com/oncology/viewarticle/946018. | |
|
Lombardi PM, Mazzola M, Giani A, Baleri S, Maspero M, De Martini P, Gualtierotti M and Ferrari G: ERAS pathway for gastric cancer surgery: Adherence, outcomes and prognostic factors for compliance in a Western centre. Updates Surg. 73:1857–1865. 2021.PubMed/NCBI View Article : Google Scholar | |
|
Salvans S, Grande L, Dal Cero M and Pera M: State of the art of enhanced recovery after surgery (ERAS) protocols in esophagogastric cancer surgery: The Western experience. Updates Surg. 75:373–382. 2023.PubMed/NCBI View Article : Google Scholar | |
|
Gong W and Li J: Combat with esophagojejunal anastomotic leakage after total gastrectomy for gastric cancer: A critical review of the literature. Int J Surg. 47:18–24. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Aurello P, Magistri P, D'Angelo F, Valabrega S, Sirimarco D, Tierno SM, Nava AK and Ramacciato G: Treatment of esophagojejunal anastomosis leakage: A systematic review from the last two decades. Am Surg. 81:450–403. 2015.PubMed/NCBI | |
|
Trapani R, Rausei S, Reddavid R and Degiuli M: ITALIAN RESEARCH GROUP FOR GASTRIC CANCER (GIRCG) Clinical Investigators. Risk factors for esophago-jejunal anastomosis leakage after total gastrectomy for cancer. A multicenter retrospective study of the Italian research group for gastric cancer. Eur J Surg Oncol. 46:2243–2247. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Xing J, Liu M, Qi X, Yu J, Fan Y, Xu K, Gao P, Tan F, Yao Z, Zhang N, et al: Risk factors for esophagojejunal anastomotic leakage after curative total gastrectomy combined with D2 lymph node dissection for gastric cancer. J Int Med Res. 49(3000605211000883)2021.PubMed/NCBI View Article : Google Scholar | |
|
Aryaie AH, Singer JL, Fayezizadeh M, Lash J and Marks JM: Efficacy of endoscopic management of leak after foregut surgery with endoscopic covered self-expanding metal stents (SEMS). Surg Endosc. 31:612–617. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Choi CW, Kang DH, Kim HW, Park SB, Kim SJ, Hwang SH and Lee SH: Full covered self-expandable metal stents for the treatment of anastomotic leak using a silk thread. Medicine (Baltimore). 96(e7439)2017.PubMed/NCBI View Article : Google Scholar | |
|
Dallal RM, Bailey L and Nahmias N: Back to basics-clinical diagnosis in bariatric surgery. Routine drains and upper GI series are unnecessary. Surg Endosc. 21:2268–2271. 2007.PubMed/NCBI View Article : Google Scholar | |
|
Haverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ruurda JP and van Hillegersberg R: Laparoscopic total gastrectomy versus open total gastrectomy for cancer: A systematic review and meta-analysis. Surg Endosc. 27:1509–1520. 2013.PubMed/NCBI View Article : Google Scholar | |
|
Liu F, Huang C, Xu Z, Su X, Zhao G, Ye J, Du X, Huang H, Hu J, Li G, et al: Morbidity and mortality of laparoscopic vs open total gastrectomy for clinical stage I gastric cancer: The CLASS02 multicenter randomized clinical trial. JAMA Oncol. 6:1590–1597. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Shi Y, Xu X, Zhao Y, Qian F, Tang B, Hao Y, Chen J and Yu P: Short-term surgical outcomes of a randomized controlled trial comparing laparoscopic versus open gastrectomy with D2 lymph node dissection for advanced gastric cancer. Surg Endosc. 32:2427–2433. 2018.PubMed/NCBI View Article : Google Scholar | |
|
Zhao B, Huang X, Lu H, Zhang J, Luo R, Xu H and Huang B: Intraoperative blood loss does not independently affect the survival outcome of gastric cancer patients who underwent curative resection. Clin Transl Oncol. 21:1197–1206. 2019.PubMed/NCBI View Article : Google Scholar | |
|
Misawa K, Kurokawa Y, Mizusawa J, Takiguchi S, Doki Y, Makino S, Choda Y, Takeno A, Tokunaga M, Sano T, et al: Negative impact of intraoperative blood loss on long-term outcome after curative gastrectomy for advanced gastric cancer: Exploratory analysis of the JCOG1001 phase III trial. Gastric Cancer. 25:459–467. 2022.PubMed/NCBI View Article : Google Scholar | |
|
Chen Cardenas SM, Santhanam P, Morris-Wiseman L, Salvatori R and Hamrahian AH: Perioperative evaluation and management of patients on glucocorticoids. J Endocr Soc. 7(bvac185)2022.PubMed/NCBI View Article : Google Scholar | |
|
Marrelli D, Piccioni SA, Carbone L, Petrioli R, Costantini M, Malagnino V, Bagnacci G, Rizzoli G, Calomino N, Piagnerelli R, et al: Posterior and Para-Aortic (D2plus) Lymphadenectomy after Neoadjuvant/conversion therapy for locally Advanced/oligometastatic gastric cancer. Cancers. 16(1376)2024.PubMed/NCBI View Article : Google Scholar | |
|
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, et al: The 2016 update of the international study group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 161:584–591. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Jensen MP, Chen C and Brugger AM: Interpretation of visual analog scale ratings and change scores: A reanalysis of two clinical trials of postoperative pain. J Pain. 4:407–414. 2003.PubMed/NCBI View Article : Google Scholar | |
|
World Medical A. World medical association declaration of helsinki: Ethical principles for medical research involving human subjects. JAMA. 310:2191–2194. 2013.PubMed/NCBI View Article : Google Scholar | |
|
(ICH) ICfH: Guideline for good clinical practice E6(R2), ICH, 2016. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf. | |
|
Team RDC: R: A language and environment for statistical computing. Foundation for Statistical Computing, 2010. | |
|
Ho D, Imai K, King G and Stuart EA: MatchIt: Nonparametric preprocessing for parametric causal inference. J Statistical Software. 42:1–28. 2011. | |
|
Keele L: An overview of rbounds: An R package for Rosenbaum bounds sensitivity analysis with matched data. White Paper Columbus, OH. 1(15)2010. | |
|
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, et al: The Clavien-dindo classification of surgical complications: Five-year experience. Ann Surg. 250:187–196. 2009.PubMed/NCBI View Article : Google Scholar | |
|
Dindo D, Demartines N and Clavien PA: Classification of surgical complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 240:205–213. 2004.PubMed/NCBI View Article : Google Scholar | |
|
Eleftheriou MM, Triantafyllou Τ, Bananis K, Chrysikos D and Theodorou D: Hybrid intraoperative sutured stenting for anastomotic leak after total gastrectomy. J Clin Med Img Case Rep. 3(1502)2023. | |
|
Desiderio J, Trastulli S, D'Andrea V and Parisi A: Enhanced recovery after surgery for gastric cancer (ERAS-GC): Optimizing patient outcome. Transl Gastroenterol Hepatol. 5(11)2020.PubMed/NCBI View Article : Google Scholar | |
|
Rekavari SG and Mahakalkar C: Prophylactic Intra-abdominal drains in major elective surgeries: A comprehensive review. Cureus. 16(e54056)2024.PubMed/NCBI View Article : Google Scholar | |
|
Pang HY, Chen LH, Chen XF, Yan MH, Chen ZX and Sun H: Prophylactic drainage versus non-drainage following gastric cancer surgery: A meta-analysis of randomized controlled trials and observational studies. World J Surg Oncol. 21(166)2023.PubMed/NCBI View Article : Google Scholar | |
|
Marano L, Verre L, Carbone L, Poto GE, Fusario D, Venezia DF, Calomino N, Kaźmierczak-Siedlecka K, Polom K, Marrelli D, et al: Current trends in volume and surgical outcomes in gastric cancer. J Clin Med. 12(2708)2023.PubMed/NCBI View Article : Google Scholar | |
|
Nakaseko Y, Haruki K, Shiba H, Horiuchi T, Saito N, Sakamoto T, Gocho T and Yanaga K: Impact of fresh frozen plasma transfusion on postoperative inflammation and prognosis of colorectal liver metastases. J Surg Res. 226:157–165. 2018.PubMed/NCBI View Article : Google Scholar | |
|
Ecker BL, Simmons KD, Zaheer S, Poe SL, Bartlett EK, Drebin JA, Fraker DL, Kelz RR, Roses RE and Karakousis GC: Blood transfusion in major abdominal surgery for malignant tumors: A trend analysis using the national surgical quality improvement program. JAMA Surg. 151:518–525. 2016.PubMed/NCBI View Article : Google Scholar | |
|
Ferraris VA, Davenport DL, Saha SP, Austin PC and Zwischenberger JB: Surgical outcomes and transfusion of minimal amounts of blood in the operating room. Arch Surg. 147:49–55. 2012.PubMed/NCBI View Article : Google Scholar | |
|
Bednarsch J, Czigany Z, Lurje I, Trautwein C, Ludde T, Strnad P, Gaisa NT, Barabasch A, Bruners P, Ulmer T, et al: Intraoperative transfusion of fresh frozen plasma predicts morbidity following partial liver resection for hepatocellular carcinoma. J Gastrointest Surg. 25:1212–1223. 2021.PubMed/NCBI View Article : Google Scholar | |
|
Li ZW, Shu XP, Wen ZL, Liu F, Liu XR, Lv Q, Liu XY, Zhang W and Peng D: Effect of intraoperative blood loss on postoperative complications and prognosis of patients with colorectal cancer: A meta-analysis. Biomed Rep. 20(22)2024.PubMed/NCBI View Article : Google Scholar | |
|
Shah A, Palmer AJR and Klein AA: Strategies to minimize intraoperative blood loss during major surgery. Br J Surg. 107:e26–e38. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Simões CM, Carmona MJC, Hajjar LA, Vincent JL, Landoni G, Belletti A, Vieira JE, de Almeida JP, de Almeida EP, Ribeiro U Jr, et al: Predictors of major complications after elective abdominal surgery in cancer patients. BMC Anesthesiol. 18(49)2018.PubMed/NCBI View Article : Google Scholar | |
|
Sugisawa N, Tokunaga M, Tanizawa Y, Bando E, Kawamura T and Terashima M: Intra-abdominal infectious complications following gastrectomy in patients with excessive visceral fat. Gastric Cancer. 15:206–212. 2012.PubMed/NCBI View Article : Google Scholar | |
|
Takebayashi K, Murata S, Kaida S, Yamaguchi T, Otake R, Miyake T, Ueki T, Kojima M, Iida H, Maehira H, et al: Adverse impact of postoperative intra-abdominal infectious complications on cancer Recurrence-related survival after curative gastric cancer surgery. Am J Surg. 224:949–954. 2022.PubMed/NCBI View Article : Google Scholar | |
|
Lamb PJ, Griffin SM, Chandrashekar MV, Richardson DL, Karat D and Hayes N: Prospective study of routine contrast radiology after total gastrectomy. Br J Surg. 91:1015–1019. 2004.PubMed/NCBI View Article : Google Scholar | |
|
Aday U, Gündeş E, Çiyiltepe H, Çetin DA, Gülmez S, Senger AS, Değer KC and Duman M: Examination of anastomotic leak with aqueous contrast swallow after total gastrectomy: Should it be carried out routinely? Contemp Oncol (Pozn). 21:224–227. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Li SS, Costantino CL and Mullen JT: Morbidity and mortality of total gastrectomy: A comprehensive analysis of 90-Day outcomes. J Gastrointest Surg. 23:1340–1348. 2019.PubMed/NCBI View Article : Google Scholar | |
|
El-Sourani N, Bruns H, Troja A, Raab HR and Antolovic D: Routine use of contrast swallow after total gastrectomy and esophagectomy: Is it justified? Pol J Radiol. 82:170–173. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Parisi A, Desiderio J, Cirocchi R and Trastulli S: Enhanced recovery after surgery (ERAS): A systematic review of randomised controlled trials (RCTs) in bariatric surgery. Obes Surg. 30:5071–5085. 2020.PubMed/NCBI View Article : Google Scholar | |
|
Davey MG, Donlon NE, Fearon NM, Heneghan HM and Conneely JB: Evaluating the impact of enhanced recovery after surgery protocols on surgical outcomes following bariatric Surgery-A systematic review and Meta-analysis of randomised clinical trials. Obes Surg. 34:778–789. 2024.PubMed/NCBI View Article : Google Scholar | |
|
Feng F, Ji G, Li JP, Li XH, Shi H, Zhao ZW, Wu GS, Liu XN and Zhao QC: Fast-track surgery could improve postoperative recovery in radical total gastrectomy patients. World J Gastroenterol. 19:3642–3648. 2013.PubMed/NCBI View Article : Google Scholar | |
|
Albanopoulos K, Alevizos L, Linardoutsos D, Menenakos E, Stamou K, Vlachos K, Zografos G and Leandros E: Routine abdominal drains after laparoscopic sleeve gastrectomy: A retrospective review of 353 patients. Obes Surg. 21:687–691. 2011.PubMed/NCBI View Article : Google Scholar | |
|
Ding J, Sun B, Song P, Liu S, Chen H, Feng M and Guan W: The application of enhanced recovery after surgery (ERAS)/fast-track surgery in gastrectomy for gastric cancer: A systematic review and Meta-analysis. Oncotarget. 8:75699–75711. 2017.PubMed/NCBI View Article : Google Scholar | |
|
Lee Y, Yu J, Doumouras AG, Li J and Hong D: Enhanced recovery after surgery (ERAS) versus standard recovery for elective gastric cancer surgery: A meta-analysis of randomized controlled trials. Surg Oncol. 32:75–87. 2020.PubMed/NCBI View Article : Google Scholar |
