NCT00529412

Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Nihon University · Academic / Other
• Sex: All
• Age: 79 Years
• Healthy volunteers: Not accepted

Summary

To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.

Detailed description

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, two 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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
OTHER	Seprafilm	two sheets per body

Timeline

• Start date: 2003-08-01
• Completion: 2007-03-01
• First posted: 2007-09-14
• Last updated: 2007-09-14

Locations

1 site across 1 country: Japan