OBJECTIVE: This randomized controlled trial was designed to assess whether the use of a sodium hyaluronate-based bioresorbable membrane reduces small bowel obstructionafter gastrectomy for gastric cancer. SUMMARY BACKGROUND DATA: 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.
RCT Entities:
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. SUMMARY BACKGROUND DATA: 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.
Authors: Rizal Lim; Jonathan M Morrill; Ryan C Lynch; Karen L Reed; Adam C Gower; Susan E Leeman; Arthur F Stucchi; James M Becker Journal: J Gastrointest Surg Date: 2008-10-15 Impact factor: 3.452
Authors: Michael R Cassidy; Alan C Sherburne; Holly K Sheldon; Melanie L Gainsbury; Stanley Heydrick; Arthur F Stucchi Journal: Surgery Date: 2013-11-14 Impact factor: 3.982