Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

• Sponsor: Nihon University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00529412
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Other: Seprafilm	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
• Study Start Date: Aug 1, 2003
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control no Seprafilm	Other: Seprafilm; two sheets per body
Active Comparator: Seprafilm	Other: Seprafilm; two sheets per body

Outcome Measures

Primary Outcome Measures

1. incidence of small bowel obstruction [3 years, more than 6 months after gastrectomy]

Secondary Outcome Measures

1. intraoperative and postoperative morbidity and mortality. [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Digestive Surgery, NIhon University School of Medicine	Tokyo		Japan	173-8610

Sponsors and Collaborators

• Nihon University

Investigators

• Study Chair: Tadatoshi Takayama, MD, PhD, Department of Digestive Surgery, Nihon University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00529412
• Other Study ID Numbers: NUSM-CC-01
• First Posted: Sep 14, 2007
• Last Update Posted: Sep 14, 2007
• Last Verified: Jun 1, 2007

• Additional relevant MeSH terms: Stomach Neoplasms; Intestinal Obstruction

Study Results

No Results Posted as of Sep 14, 2007