Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial

Staple line failure, although uncommon, can result in significant morbidity and, even, mortality. Staple line buttressing has been developed to improve staple line strength, decrease bleeding, and minimize the risk of leak. Many different products are currently available. However, most have not been proved in clinical trials for their clinical relevance.

From April 2004 to March 2005, 48 morbidly obese patients who had undergone laparoscopic Roux-en-Y gastric bypass were enrolled in this study. The patients were randomly allocated to 2 groups according to whether polyglycolide acid and trimethylene carbonate (Seamguard) was (group 1, n = 24) or was not (group 2, n = 24) used in an investigator-initiated study. All patients underwent barium radiography at 3 and 12 months postoperatively.

Peri- and postoperative mortality were absent. The intraoperative methylene blue test was positive in 1 patient in group 2. No conversion to laparotomy was needed. No patient required reoperation or transfusion for extraluminal bleeding, and no anastomotic leaks were detected in either group postoperatively. The mean number of clip instruments used was significantly lower in group 1 patients (2 versus 22, P <.0001, odds ratio 121.0, 95% confidence interval 12.5-1491). The operative time was significantly less in group 1 (115 +/- 30.0 min, range 85-210) compared with that in group 2 (150 +/- 51.7 min, range 90-240; P <.05). The postoperative hemoglobin level was significantly greater in group 1 (12.47 +/- 1.7 mg/dL, range 9.2-14.8) compared with that in group 2 (11.1 +/- 1.9 mg/dL, range 8.1-14.6; P <.05). Gastrogastric fistula formation was detected in 3 patients (12.5%) in group 2, with no statistically significant difference (P = .2).

The results of our study have shown that synthetic reinforcement material minimizes staple line bleeding and reduces the operative time, with no animal source contamination. No adverse events related to the resorbable buttressing material were observed.