Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

September 13, 2007 updated by: Nihon University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 173-8610
        • Department of Digestive Surgery, Nihon University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 79 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of small bowel obstruction
Time Frame: 3 years, more than 6 months after gastrectomy
3 years, more than 6 months after gastrectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
intraoperative and postoperative morbidity and mortality.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2007

Last Update Submitted That Met QC Criteria

September 13, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUSM-CC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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