Buttressing the Staple Line: A Randomized Comparison Between Staple-Line Reinforcement Versus No Reinforcement During Sleeve Gastrectomy

Abstract

Bariatric surgery is recommended for Indian patients with body mass index (BMI) >32.5 kg/m2 with at least one comorbidity and >37.5 kg/m2 without a comorbidity. In laparoscopic sleeve gastrectomy, bleeding and leakage from the staple line are common post-operative events. Peri-Strips Dry® with Veritas® (PSD-V) is used in staple-line reinforcement. This was a single-investigator, multicenter, randomized study of 100 patients undergoing standard sleeve gastrectomy with a 34 or 36 French bougie. Patients were randomized 1:1 to PSD-V or control groups; no buttress material was used in the control group. The primary objective was to assess complication rates (any staple-line bleed or leak from the intra-operative visit through day 30) associated with sleeve gastrectomy. Surgical time (from first incision to closure of last incision) and the number of clips and/or sutures used to control bleeding were also assessed. Fewer staple-line bleeds were observed in the PSD-V group than the control group (23/51 [45.1 %] vs 39/49 [79.6 %] patients; p = 0.0005), and the bleeding was of a lower severity (p = 0.0002). No staple-line leaks were observed. Surgical time was shorter in patients who received PSD-V (58.8 vs 72.8 min; p = 0.0153), and fewer patients required hemostatic clips and/or sutures (10/51 [19.6 %] vs 33/49 [67.3 %] patients; p < 0.0001). Fewer patients in the PSD-V than the control group experienced adverse events (2/51 [3.9 %] vs 5/49 [10.2 %] patients). The use of PSD-V reduced the incidence and severity of staple-line bleeding and was associated with a reduction in surgical time compared with no staple-line reinforcement.

The effect of oversewing the staple line in laparoscopic sleeve gastrectomy: randomized control trial.

“…Our review of the literature identified 4 papers [12–15], only 3 of which evaluated oversewing as a method of reinforcement [13–15]. We included 3 additional papers [16–18] not identified in our PubMed search.…”

“…However, there is sample bias in most studies of staple-line reinforcement. Because a sample size of > 1000 patients would be needed to reach statistical significance for postoperative bleeding and gastric leaks [12], the studies are unable to detect the differences between analyzed groups because of low power [13–18]. …”

Assessing Bleeding Risk in Bariatric Surgeries: A Retrospective Analysis Study

“…Berger et al [39] compared suture with 2 buttressing pledgets and did not find any differences in terms of bleeding. Shashank et al [40] reported that reinforcement of the line produces more leaks, but they did not note any differences in terms of bleeding. Wanjura et al [41] reported decreased bleeding with the addition of sutures, compared with no sutures.…”

Laparoscopic Sleeve Gastrectomy: To Suture or not to Suture Staple Line?

“…In a randomized comparison, Shah et al found no significant difference in the leak rates in their set of patients. In the subset of patients with BMI < 43 they found increased bleeding risk from the staple line in the group where it was not reinforced as compared to those where PSD (Peri-strips dry) were used [ 11 ]. In a review by Chen et al, the authors comment that there is no reason to believe that the reinforcement leads to the reduction in the rate of staple line leak or bleeding [ 17 ].…”

“…Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is till date no consensus on which technique is best for reducing the risk of leak. These intra-operative techniques include over-sewing the staple line, using absorbable or non-absorbable suturing material, omental wrap, and fibrin glues and so forth [ 11 ].…”