Gastrointestinal (GI) surgery encompasses a wide range of procedures performed for malignant and benign conditions, including colorectal, gastric, and pancreatic malignancies, inflammatory bowel disease, intestinal obstruction, ischemia, trauma, and gastrointestinal perforation [1]. A substantial proportion of these procedures involve bowel resection followed by restoration of intestinal continuity through an intestinal anastomosis [2,3]. The integrity of the anastomosis is therefore a major determinant of postoperative outcome, as anastomotic failure can result in serious complications such as intra-abdominal infection, abscess formation, peritonitis, sepsis, prolonged hospitalization, and increased mortality [4]. A successful intestinal anastomosis requires accurate approximation of viable bowel with adequate blood supply, minimal tension, and secure tissue apposition [5]. Over the years, several techniques have been developed to achieve these objectives. Hand-sewn anastomosis represents the traditional approach and can be adapted to different bowel locations and clinical situations. It is relatively inexpensive and does not require specialized equipment; however, construction may be time-consuming and technically demanding, with outcomes potentially influenced by surgeon experience [6,7]. The development of mechanical stapling devices has provided an alternative method for intestinal reconstruction. Stapled anastomosis can facilitate rapid and standardized tissue approximation and may reduce the time required to construct the anastomosis [8]. Nevertheless, stapling has limitations, including higher cost, dependence on specialized equipment, and the possibility of complications such as bleeding, anastomotic leakage, stricture, and staple-line ischemia [8]. Consequently, hand-sewn techniques continue to have an important role, particularly in settings where access to stapling devices is limited. Despite extensive use of both techniques, there is no universally accepted approach for selecting stapled or hand-sewn anastomosis in all gastrointestinal procedures [5]. The choice is frequently influenced by the anatomical site, nature of the underlying pathology, condition of the bowel, operative setting, surgeon experience, and availability of equipment. Existing comparative studies have reported advantages of stapling in operative efficiency and postoperative recovery, while evidence regarding its superiority in preventing anastomotic leakage remains inconsistent. Anastomotic leak is among the most clinically important complications following gastrointestinal anastomosis and can substantially influence postoperative morbidity and mortality [4]. Therefore, evaluating anastomotic safety alongside operative and postoperative recovery parameters is important when comparing the two techniques. The present study was undertaken as a prospective observational comparative study to evaluate hand-sewn and stapled gastrointestinal anastomoses in patients undergoing gastrointestinal surgery. Anastomotic leak was considered the primary outcome, while secondary outcomes included anastomosis time, return of bowel function, time to initiation of oral feeding, duration of hospital stay, postoperative pain, surgical-site infection, and postoperative mortality. The study aimed to determine whether stapled anastomosis provides clinically meaningful advantages over the conventional hand-sewn technique in terms of anastomotic safety and postoperative recovery.

Patient Selection This prospective observational comparative study was conducted in the Department of General Surgery, Vilasrao Deshmukh Government Medical College and Hospital, Latur, Maharashtra, a tertiary care institute, during the period of December 2024 to August 2026. Adult patients aged ≥18 years undergoing gastrointestinal surgery requiring an intestinal anastomosis were enrolled. Patients undergoing procedures such as small bowel resection with anastomosis, ileocolic anastomosis, hemicolectomy, colorectal anastomosis, or gastrojejunostomy were considered for inclusion. Both elective and emergency procedures were included. Patients aged <18 years, pregnant patients, patients with known immunocompromised states, patients undergoing revision of a previous anastomosis, and patients unwilling to provide informed consent were excluded. Based on the technique used for reconstruction, patients were categorized into two groups: Group A: Hand-sewn anastomosis (n=50) Group B: Stapled anastomosis (n=50) The choice of anastomotic technique was determined by the operating surgeon based on the clinical condition of the patient, intraoperative findings, site and configuration of the anastomosis, and surgeon preference. No randomization was performed. Written informed consent was obtained from all participants before enrolment. The study was conducted after obtaining approval from the Institutional Ethics Committee and in accordance with the principles of the Declaration of Helsinki. Study Outcomes The primary outcome was the incidence of anastomotic leak in the hand-sewn and stapled groups. Anastomotic leak was defined as a clinically or radiologically confirmed disruption of the anastomosis requiring conservative management, percutaneous intervention, or reoperation. Secondary outcomes included anastomosis time, total operative time, return of bowel function, time to initiation of oral feeding, duration of hospital stay, postoperative pain, surgical-site infection, and postoperative mortality. Postoperative pain was assessed using the Visual Analog Scale (VAS). Surgical-site infection was assessed clinically according to standard criteria. Patients were monitored during hospitalization for postoperative complications and, where applicable, followed for 30 days postoperatively for anastomotic leak, reoperation, readmission, and mortality. Sample Size The sample size was determined with anastomotic leak as the primary outcome, based on the findings of Kshirsagar et al., who reported an anastomotic leak rate of 16% in the hand-sewn group and 0% in the stapled group among elective cases. Assuming a two-sided α of 0.05, 80% power, and a 1:1 allocation ratio, the required sample size was estimated using a two-proportion comparison method. Considering the low expected event rate and allowing for potential exclusions or loss to follow-up, a total sample size of 100 patients, with 50 patients in each group, was selected for the present study. Operative Technique Hand-sewn anastomoses were performed using appropriate absorbable or non-absorbable sutures according to the surgeon's preference and the anatomical site of the anastomosis. The configuration of the anastomosis, suture material, number of layers, and suturing technique were documented. ( Fig 1 a and 1b) Data Collection and Statistical Analysis Demographic, clinical, operative and postoperative data were collected prospectively using a structured case record form. Categorical variables were expressed as frequencies and percentages. Continuous variables were expressed as mean ± standard deviation for normally distributed data or as median with interquartile range for non-normally distributed data. The incidence of anastomotic leak and other categorical outcomes was compared between the two groups using the Chi-square test or Fisher's exact test, as appropriate. Continuous variables were compared using the independent-samples t-test for normally distributed data and the Mann–Whitney U test for non-normally distributed data. Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). A two-sided p-value <0.05 was considered statistically significant.

Stapled anastomoses were performed using an appropriate gastrointestinal stapling device selected according to the anatomical site and operative requirements. The type and size of stapler and configuration of the anastomosis were recorded. (Figure 2a and 2b) For each patient, the site and configuration of anastomosis, anastomosis time, total operative time, intraoperative blood loss, degree of intra-abdominal contamination, and creation of a protective stoma, if applicable, were documented. A total of 100 patients were included in the study, with 50 patients in each group. The age distribution was comparable between the hand-sewn and stapled groups. The largest proportion of patients belonged to the 41–50-year age group (36.0% and 38.0%, respectively), followed by the 31–40-year age group (24.0% and 26.0%). There was no statistically significant difference in age distribution between the groups (P = 0.933). Similarly, sex distribution was comparable, with males comprising 56.0% of the hand-sewn group and 64.0% of the stapled group (P = 0.414). Regarding ASA physical status, most patients were classified as ASA II (60.0% and 52.0%, respectively), followed by ASA III. The distribution of ASA physical status was not significantly different between the groups (P = 0.758). Overall, the two groups were comparable with respect to baseline demographic and preoperative characteristics (Table 1) Table 1: Baseline demographic and preoperative characteristics Characteristic Hand-sewn (n=50), n (%) Stapled (n=50), n (%) P value Age (years) 0.933 21–30 5 (10.0) 5 (10.0) 31–40 12 (24.0) 13 (26.0) 41–50 18 (36.0) 19 (38.0) 51–60 10 (20.0) 9 (18.0) >60 5 (10.0) 6 (12.0) Gender 0.414 Male 28 (56.0) 32 (64.0) Female 22 (44.0) 18 (36.0) ASA physical status 0.758 ASA I 5 (10.0) 4 (8.0) ASA II 30 (60.0) 26 (52.0) ASA III 15 (30.0) 20 (40.0) AS IV 0 (0.0) 0 (0.0) Elective cases 30(60.0) 40(80%) 0.018 Emergency cases 20 (40.0) 10(20%) Values are expressed as number (percentage). P values were calculated using Pearson's chi-square test. ASA, American Society of Anaesthesiologists physical status classification. A P value <0.05 was considered statistically significant. The distribution of clinical diagnoses was comparable between the two groups (Table 2). Perforation was the most common indication for surgery, occurring in 22 (44.0%) patients in the hand-sewn group and 20 (40.0%) patients in the stapled group. Obstruction with gangrenous bowel was observed in 18 (36.0%) and 16 (32.0%) patients, respectively. Malignancy accounted for 7 (14.0%) cases in the hand-sewn group and 10 (20.0%) cases in the stapled group, while trauma accounted for 3 (6.0%) and 4 (8.0%) cases, respectively. There was no statistically significant difference in the distribution of clinical diagnoses between the groups (χ² = 1.022, P = 0.796). The distribution of elective and emergency procedures was 60.0% and 40.0%, respectively, in the hand-sewn group and 80.0% and 20.0%, respectively, in the stapled group (χ² = 5.556, P = 0.018). Although the distribution differed statistically between the groups, both elective and emergency procedures were represented in each group. Table 2: Distribution of clinical diagnoses among patients in the hand-sewn and stapled groups Clinical diagnosis Hand-sewn (n=50) n (%) Stapled (n=50) n (%) χ² P value Perforation 22 (44.0) 20 (40.0) Obstruction with gangrenous bowel 18 (36.0) 16 (32.0) 1.022 0.796 Malignancy 7 (14.0) 10 (20.0) Trauma 3 (6.0) 4 (8.0) Values are expressed as number (percentage). The χ² and P value represent the overall comparison of clinical diagnosis between the hand-sewn and stapled groups using Pearson's chi-square test. A P value <0.05 was considered statistically significant. The distribution of the site of anastomosis differed significantly between the hand-sewn and stapled groups (χ² = 123.25, P < 0.001) (Table 3). Ileoileal anastomosis was the most common site in the hand-sewn group, occurring in 33 (66.0%) patients, whereas ileotransverse anastomosis predominated in the stapled group, occurring in 30 (60.0%) patients. Jejunoileal anastomosis was performed in 4 (8.0%) patients in the hand-sewn group and 3 (6.0%) patients in the stapled group, while jejunojejunal anastomosis was performed in 3 (6.0%) and 10 (20.0%) patients, respectively. The configuration of anastomosis also differed descriptively between the groups. End-to-end anastomosis was performed in 43 (86.0%) hand-sewn cases and 8 (16.0%) stapled cases, whereas side-to-side anastomosis was performed in none of the hand-sewn cases and 42 (84.0%) stapled cases. End-to-side anastomosis was performed in 7 (14.0%) hand-sewn cases and none of the stapled cases. Because of the presence of zero cell frequencies, formal statistical comparison of anastomotic configuration was not performed. Table 3: Distribution of anastomotic site and configuration in the hand-sewn and stapled groups Parameter Type of anastomosis Hand-sewn (n=50), n (%) Stapled (n=50), n (%) χ² P value Site of anastomosis Ileoileal 33 (66.0) 7 (14.0) 123.25 <0.001 Ileotransverse 10 (20.0) 30 (60.0) Jejunoileal 4 (9.0) 3 (06.0) Jejunojejunal 3 (6.0) 10 (20.0) Type of anastomosis End to end 43 (86.0) 8 (16.0) End to side 7 (4.0) 0 (0.0) Side to side 0 (0.0) 42 (84.0) Values are presented as number (percentage). The χ² and P value for the site of anastomosis represent the overall comparison between groups using Pearson's chi-square test. A P value <0.05 was considered statistically significant. The χ² test was not applied to the type of anastomosis because of zero cell frequencies; therefore, these data are presented descriptively. Anastomotic leak, the primary outcome of the study, occurred in 7 (14.0%) patients in the hand-sewn group and 5 (10.0%) patients in the stapled group. There was no statistically significant difference in the incidence of anastomotic leak between the two groups (Fisher's exact test, P = 0.759). Of the 20 emergency cases in the hand-sewn group, 5 (25.0%) developed anastomotic leakage, compared with 2 (6.7%) of the 30 elective cases. In the stapled group, anastomotic leakage occurred in 3 (30.0%) of 10 emergency cases and 2 (5.0%) of 40 elective cases. Surgical-site infection occurred in 5 (10.0%) patients in the hand-sewn group and 6 (12.0%) patients in the stapled group, with no statistically significant difference between the groups (P = 0.749). Postoperative pain with a score >3 was observed in 12 (24.0%) patients in the hand-sewn group and 15 (30.0%) patients in the stapled group, with no statistically significant difference (P = 0.497). No postoperative mortality occurred in either group. Table 4: Comparison of postoperative outcomes between the hand-sewn and stapled groups Parameter Hand-sewn (n=50), n (%) Stapled (n=50), n (%) Statistical test P value Anastomotic leak emergency case elective case 7(14.0) 5/20 (25.0%) 2/30 (6.7%) 5 (10.0) 3/10 (30.0%) 2(5%) Fisher's exact test 0.759 Surgical site infection 5 (10.0) 6 (12.0) Pearson χ² 0.749 Postoperative pain(>3) 12 (24.0) 15 (30.0) Pearson χ² 0.497 Mortality 0 (0.0) 0 (0.0) Fisher's exact test 1.000 Values are presented as number (percentage). χ² values were calculated using Pearson's chi-square test. †Fisher's exact test was used for mortality because of zero events in both groups. A P value <0.05 was considered statistically significant. The mean time required to perform the anastomosis was significantly shorter in the stapled group than in the hand-sewn group (7.23 ± 5.29 vs. 30.32 ± 7.33 minutes; t = 18.07, P < 0.001) (Table 5). The mean duration of hospital stay was also significantly shorter in the stapled group (10.50 ± 2.08 vs. 15.26 ± 5.61 days; t = 5.63, P < 0.001). Return of bowel function occurred significantly earlier following stapled anastomosis (3.20 ± 0.76 vs. 3.50 ± 0.56 days; t = 2.25, P = 0.027). Similarly, oral feeding was initiated significantly earlier in the stapled group (5.06 ± 1.06 vs. 6.50 ± 1.88 days; t = 4.72, P < 0.001). Overall, stapled anastomosis was associated with significantly shorter anastomosis time, earlier return of bowel function, earlier initiation of oral feeding, and shorter hospital stay, while no significant differences were observed in anastomotic leak, surgical-site infection, postoperative pain, or mortality. Table 5: Comparison of operative and postoperative recovery parameters between the hand-sewn and stapled groups Parameter Hand-sewn (n=50) n (%) Stapled (n=50) n (%) t value P value Time for anastomosis in minutes 30.32± 7.33 7.23±5.29 18.07 <0.001 Duration of hospital stay in days 15.26±5.61 10.50±2.08 5.63 <0.001 Return of bowel function in days 3.50±0.56 3.2 ±0.76 2.25 0.027 Starting of oral feeds (in days) 6.50±1.88 5.06±1.06 4.72 <0.001 Values are expressed as mean ± standard deviation. t values were calculated using an independent-samples t-test comparing the hand-sewn and stapled groups. A P value <0.05 was considered statistically significant.

restoring bowel continuity following resection. The choice between hand-sewn and stapled techniques continues to be debated, with considerations including anastomotic safety, operative efficiency, postoperative recovery, cost, and surgeon expertise. The present study compared these two techniques in 100 patients, with anastomotic leak as the primary outcome and operative and postoperative recovery parameters as secondary outcomes. In the present study, the two groups were comparable with respect to baseline demographic characteristics, including age, sex, and ASA physical status. However, the distribution of the site of anastomosis differed significantly between the groups. This is an important consideration because the anatomical site and configuration of anastomosis may independently influence postoperative outcomes and therefore represent potential confounding factors when comparing anastomotic techniques. Anastomotic leak Anastomotic leak was the primary outcome of the present study. Leak occurred in 7 (14.0%) patients in the hand-sewn group and 5 (10.0%) patients in the stapled group. The difference was not statistically significant (Fisher's exact test, P = 0.759). Although the observed leak rate was numerically lower in the stapled group, the present study did not demonstrate a statistically significant difference between stapled and hand-sewn anastomoses with respect to anastomotic leakage. In the present study, emergency procedures constituted 40.0% of the hand-sewn group and 20.0% of the stapled group. Among emergency cases, anastomotic leakage occurred in 5 of 20 (25.0%) patients in the hand-sewn group and 3 of 10 (30.0%) patients in the stapled group. In contrast, among elective cases, leakage occurred in 2 of 30 (6.7%) patients in the hand-sewn group and 2 of 40 (5.0%) patients in the stapled group. Thus, the observed incidence of leakage was higher among emergency than elective procedures in both groups. These findings highlight the potential influence of operative setting and underlying clinical condition on anastomotic outcomes. However, because the study was not specifically powered to assess the effect of emergency versus elective surgery on anastomotic leakage, these subgroup findings should be interpreted cautiously. Our findings are comparable with those reported by Sai Viswanth et al., who observed anastomotic leakage in 2 of 26 (7.7%) patients in the hand-sewn group and 3 of 26 (11.5%) patients in the stapled group, with no statistically significant difference (P = 0.638).[9] Kshirsagar et al., however, reported a significantly lower leak rate with stapled anastomosis in elective procedures, with four leaks occurring in the hand-sewn group and none in the stapled group (P = 0.04).[10] The difference between their findings and those of the present study may be related to differences in sample size, patient selection, operative indication, distribution of elective and emergency procedures, anastomotic site, and the relatively small number of leak events. In particular, the inclusion of emergency procedures in the present study may have contributed to the higher overall observed leak rates compared with studies restricted to elective surgery. The findings of the present study are also consistent with evidence from systematic reviews and meta-analyses. A systematic review of randomized controlled trials involving 1,233 patients found no significant difference in clinical anastomotic dehiscence between stapled and hand-sewn colorectal anastomoses, although stapled anastomoses required significantly less time to construct.[11] Similarly, a meta-analysis of emergency laparotomy studies found no significant difference in anastomotic failure, leak, abscess, fistula, or postoperative mortality between stapled and hand-sewn techniques.[12] A recent systematic review and meta-analysis of observational colorectal studies also reported broadly similar rates of anastomotic leak, surgical-site infection, length of hospital stay, and mortality between the two techniques, although stapling was generally associated with shorter operative time. [13] Taken together, these findings suggest that, while stapled anastomosis may offer advantages in operative efficiency, the present study did not demonstrate a statistically significant difference in anastomotic leakage between stapled and hand-sewn techniques. Anastomosis time and operative efficiency One of the most prominent findings of the present study was the substantial reduction in the time required to perform the anastomosis with stapling. The mean anastomosis time was 7.23 ± 5.29 minutes in the stapled group compared with 30.32 ± 7.33 minutes in the hand-sewn group, representing a statistically significant difference (P < 0.001). This finding is consistent with both previous comparative studies and pooled evidence. Sai Viswanth et al. reported a mean anastomosis time of 5.81 ± 4.21 minutes with stapling compared with 25.62 ± 5.29 minutes with hand-sewn anastomosis (P < 0.001). [9] Kshirsagar et al. similarly reported significantly shorter operative duration with stapled anastomosis, particularly among elective procedures. [10] The findings are further supported by systematic reviews. A randomized-trial systematic review involving 1,233 patients demonstrated that the time required to perform an anastomosis was significantly greater with hand-sewn techniques. [11] The recent meta-analysis of observational colorectal studies likewise reported that stapled anastomoses generally required less operative time than hand-sewn anastomoses. [13] Postoperative recovery Patients in the stapled group demonstrated significantly faster postoperative recovery in the present study. The mean duration of hospital stay was 10.50 ± 2.08 days in the stapled group compared with 15.26 ± 5.61 days in the hand-sewn group (P < 0.001). Return of bowel function also occurred earlier in the stapled group (3.20 ± 0.76 vs. 3.50 ± 0.56 days; P = 0.027). Furthermore, oral feeding was initiated significantly earlier following stapled anastomosis (5.06 ± 1.06 vs. 6.50 ± 1.88 days; P < 0.001). These findings are in agreement with Sai Viswanth et al., who reported earlier initiation of oral feeding in the stapled group (2.31 ± 0.74 vs. 4.27 ± 0.67 days; P < 0.001) and a significantly shorter hospital stay (9.50 ± 2.18 vs. 12.38 ± 2.12 days; P < 0.001).[9] Kshirsagar et al. also reported significantly earlier return of bowel function and shorter hospital stay among patients undergoing stapled anastomosis, particularly in elective surgery. [10] Postoperative pain Postoperative pain scores greater than 3 were observed in 12 (24.0%) patients in the hand-sewn group and 15 (30.0%) patients in the stapled group. The difference was not statistically significant (P = 0.497). Thus, the present study did not demonstrate a significant difference in postoperative pain between the two techniques. This finding is consistent with Kshirsagar et al., who found no statistically significant difference in postoperative pain between hand-sewn and stapled anastomoses in either elective or emergency procedures.[10] The absence of a significant difference is understandable because postoperative pain is influenced by several factors, including incision size, operative approach, extent of bowel resection, duration of surgery, analgesic protocols, wound complications, and individual patient factors. Surgical-site infection Surgical-site infection occurred in 5 (10.0%) patients in the hand-sewn group and 6 (12.0%) patients in the stapled group, with no statistically significant difference (P = 0.749). Therefore, the present study did not demonstrate a significant advantage of either technique with respect to SSI. Kshirsagar et al. reported a significantly lower SSI rate with stapled anastomosis among elective cases, although this difference was not observed in emergency cases. [10] In contrast, Sai Viswanth et al. reported SSI in 30.8% of hand-sewn cases and 23.1% of stapled cases, but the difference was not statistically significant (P = 0.532).[9] The recent systematic review and meta-analysis of observational colorectal studies also found no consistent difference in SSI between stapled and hand-sewn anastomoses.[13] Mortality No postoperative mortality occurred in either group in the present study. Similarly, Sai Viswanth et al. reported no mortality in either the hand-sewn or stapled group. [9] Previous systematic reviews have also failed to demonstrate a significant mortality difference between the two techniques.[11,12] The absence of mortality in the present study is reassuring but should be interpreted cautiously because the sample size and number of postoperative events were relatively small. The findings of the present study broadly correspond with the available systematic-review evidence. A systematic review of randomized controlled trials comparing stapled and hand-sewn colorectal anastomoses concluded that there was insufficient evidence to establish overall superiority of stapling, although stapling significantly reduced the time required to construct the anastomosis. [11] Similarly, a meta-analysis specifically examining emergency laparotomy found no significant difference in anastomotic failure or postoperative complications between the two methods. [12] More recent evidence continues to support this interpretation. Ijaz Ul Haq et al., in a systematic review and meta-analysis of observational cohorts, found that anastomotic leak, SSI, length of hospital stay, and mortality were generally similar between stapled and hand-sewn colorectal anastomoses, whereas stapling frequently reduced operative time. [13] Thus, the strongest and most consistent advantage of stapling appears to be operative efficiency rather than a proven reduction in anastomotic complications. Evidence from oesophagogastric anastomoses is also informative. Markar et al., in a systematic review and meta-analysis of nine randomized trials, found no significant difference in anastomotic leakage between stapled and hand-sewn techniques, although stapling was associated with shorter operative time. [14] This emphasizes that the potential advantages of stapling may be procedure- and site-specific. The present study suggests that stapled anastomosis may provide meaningful advantages in terms of operative efficiency and postoperative recovery. The markedly shorter anastomosis time, earlier return of bowel function, earlier initiation of oral feeds, and shorter hospital stay observed with stapling may be particularly relevant in high-volume gastrointestinal surgical practice. However, the comparable anastomotic leak, SSI, pain, and mortality rates indicate that stapling should not be considered universally superior to hand-sewn anastomosis. Hand-sewn anastomosis remains an effective and versatile technique, particularly where stapling devices are unavailable, cost is an important consideration, or the anatomical situation requires individualized reconstruction. The strengths of the present study include its prospective comparative design, equal allocation of patients between the two groups, use of anastomotic leak as the primary outcome, and assessment of multiple clinically relevant postoperative outcomes. However, the study has several limitations. It was conducted at a single centre and included a relatively small number of patients. The non-randomized nature of technique selection may have introduced selection bias. In addition, the distribution of anastomotic sites and configurations differed significantly between groups, which may have acted as a confounding factor. Finally, only five anastomotic leaks occurred in the entire study population; therefore, the study had limited statistical power to detect a small difference in leak rates.

In this prospective observational study, stapled gastrointestinal anastomosis was associated with significantly shorter anastomosis time and earlier postoperative recovery, including earlier return of bowel function, earlier initiation of oral feeding, and shorter hospital stay. However, no statistically significant difference was observed in the incidence of anastomotic leak, surgical-site infection, or postoperative pain between the two techniques. The higher observed leak proportions among emergency cases in both groups highlight the importance of operative setting when interpreting anastomotic outcomes. These findings should be interpreted in light of the study's single-centre, non-randomized design, unequal distribution of anastomotic sites, and relatively small number of anastomotic leak events, which may have limited the ability to detect differences in the primary outcome.

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