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Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Seprafilm

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

undefined - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Digestive Surgery, NIhon University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control

Seprafilm

Arm Description

no Seprafilm

Outcomes

Primary Outcome Measures

incidence of small bowel obstruction

Secondary Outcome Measures

intraoperative and postoperative morbidity and mortality.

Full Information

NCT ID

NCT00529412

First Posted

September 13, 2007

Last Updated

September 13, 2007

Sponsor

Nihon University

1. Study Identification

Unique Protocol Identification Number

NCT00529412

Brief Title

Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nihon University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

no Seprafilm

Arm Title

Seprafilm

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Seprafilm

Intervention Description

two sheets per body

Primary Outcome Measure Information:

Title

incidence of small bowel obstruction

Time Frame

3 years, more than 6 months after gastrectomy

Secondary Outcome Measure Information:

Title

intraoperative and postoperative morbidity and mortality.

Time Frame

3 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tadatoshi Takayama, MD, PhD

Organizational Affiliation

Department of Digestive Surgery, Nihon University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Digestive Surgery, NIhon University School of Medicine

City

Tokyo

ZIP/Postal Code

173-8610

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

18438113

Citation

Hayashi S, Takayama T, Masuda H, Kochi M, Ishii Y, Matsuda M, Yamagata M, Fujii M. Bioresorbable membrane to reduce postoperative small bowel obstruction in patients with gastric cancer: a randomized clinical trial. Ann Surg. 2008 May;247(5):766-70. doi: 10.1097/SLA.0b013e3181656d4e.

Results Reference

derived

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Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

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