Gastric Staple Line Buttressing Using Seamguard® in Laparoscopic Gastric Bypass : A Prospective Randomized Trial

Philippe A Topart, MD, Guillaume Becouarn, MD. Societe de Chirurgie Viscerale, Clinique de l’Anjou

Objectives : To evaluate the impact of the systematic reinforcement of the gastric staple line with Seamguard® (absorbable polyglycolic acid:trimethylene carbonate) on per and postoperative blood loss and as a secondary endpoint on the frequency of gastric leaks after Roux-en-Y gastric bypass (RYGB).

Methods and procedures : From July to December 2009, 82 patients were randomly assigned to receive staple line butressing or not after informed consent and IRB approval. All the laparoscopic RYGBs were done according to the same procedure by 2 surgeons at 1 institution. A 10-30 cc vertical gastric pouch was created by a 60 mm linear stapler using gold loads. A side to side gastrojejunal jejunal anastomosis used blue loads. Buttressing material was used only on the gastric staple line. Only patients candidate to a primary RYGB without significant surgical history were consecutively enrolled. During the surgery the number of hemostatic clips applied on the gastric staple line to achieve satisfactory hemostasis was recorded. Blood loss was recorded per- as well as postoperatively through a systematic abdominal suction drainage left in place for 72 hours. Hemoglobin levels were assessed on postop day 1 and 2 and compared to preoperative values. A gastrograffin swallow was scheduled on postop day 2. Student t test was used to assess diffrences between groups.

Results : During the study period in addition to the 82 enrolled patients, 3 patients refused to participate and 3 were not eligible because sleeve gastrectomy was performed instead of initially scheduled RYGB. 41 patients received staple line butressing and 41 were controls. Group demographics were similar.

One control group patient had peroperative short vessel bleeding and data was not included in the study. There were significantly more complications in the Seamguard group (21.9% ; 9 patients) compared to 1 transient bowel obstruction in the control group. 2 patients had a bleeding at the level of the jejunojejunal (required reoperation) and the gastrojejunal anastomoses (endoscopic control). Other significant complications in the Seamguard group were bowel obstructions developped at the jejunojejunal anastomosis in 5 patients (4 related to closure of the mesenteric defect). One of these led to disruption of the gastric staple line on postop day 5. There was no postoperative death in any of the groups. No abnormality was observed on barium swallows in both groups.

Conclusions : Systematic gastric staple line reinforcement with Seamguard led to a better hemostatic control with significantly less clips required. However, except for the complications related to the jejunojenunal anastomosis, no significant difference was found between the 2 groups regarding blood loss.