Bioresorbable membrane to reduce postoperative small bowel obstruction in patients with gastric cancer: a randomized clinical trial.
OBJECTIVE
This randomized controlled trial was designed to assess whether the use of a sodium hyaluronate-based bioresorbable membrane reduces small bowel obstruction after gastrectomy for gastric cancer.


BACKGROUND
Clinical studies have reported that a bioresorbable membrane significantly reduces the incidence and severity of adhesion after abdominopelvic surgery.


METHODS
Between 2003 and 2006, a total of 150 patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, 2 sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality. We registered with Clinical Trials.gov using the Protocol Registration System (ID-NCT00529412).


RESULTS
We evaluated a total of 144 patients: 70 in the Seprafilm group and 74 in the control group. The overall incidence (Seprafilm group, 5.7% vs. control group, 9.5%; P = 0.534) and the cumulative incidence of small bowel obstruction (6.2% vs. 12.2% at 36 months; P = 0.3789) were slightly but not significantly lower in the Seprafilm group. The incidence of postoperative complications was similar in the groups (32.9% vs. 29.7%; P = 0.722). Seprafilm did not adversely affect bowel, liver, or renal functions.


CONCLUSIONS
The use of Seprafilm does not significantly reduce the incidence of small bowel obstruction in patients undergoing gastrectomy for gastric cancer.
Hayashi
Shigeoki
S
Department of Digestive Surgery, Nihon University School of Medicine, Itabashi-ku, Tokyo, Japan. hshige@med.nihon-u.ac.jp
Takayama
Tadatoshi
T
Masuda
Hideki
H
Kochi
Mitsugu
M
Ishii
Yukimoto
Y
Matsuda
Minoru
M
Yamagata
Motoo
M
Fujii
Masashi
M
D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy / Q000009:adverse effects*; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D015994:Incidence; D007415:Intestinal Obstruction / Q000453:epidemiology / Q000517:prevention & control*; D007421:Intestine, Small; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D016037:Single-Blind Method; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome
D008567:Membranes, Artificial; C118198:Seprafilm; D006820:Hyaluronic Acid