Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529412
• Other study ID #: NUSM-CC-01
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2007
• Last updated: September 13, 2007
• Start date: August 2003
• Est. completion date: March 2007

Study information

• Verified date: June 2007
• Source: Nihon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 79 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of gastric cancer

• Operable

Exclusion Criteria:

• Withdrew consent

• Pregnant

• Ascites

• Distant metastasis

• Liver dysfunction (serum total bilirubin >2.0 mg/dL)

• Renal failure (serum creatinine >1.5 mg/dL)

• A past history of small bowel obstruction.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Intestinal Obstruction
• Stomach Neoplasms

Intervention

Other:
• Seprafilm
two sheets per body

Locations

Country	Name	City	State
Japan	Department of Digestive Surgery, NIhon University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nihon University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of small bowel obstruction		3 years, more than 6 months after gastrectomy
Secondary	intraoperative and postoperative morbidity and mortality.		3 years