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Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

NCT ID: NCT00529412

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control

no Seprafilm

Group Type NO_INTERVENTION

Seprafilm

Intervention Type OTHER

two sheets per body

Seprafilm

Group Type ACTIVE_COMPARATOR

Seprafilm

Intervention Type OTHER

two sheets per body

Interventions

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Seprafilm

two sheets per body

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon University

OTHER

Sponsor Role lead

Principal Investigators

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Tadatoshi Takayama, MD, PhD

Role: STUDY_CHAIR

Department of Digestive Surgery, Nihon University School of Medicine

Locations

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Department of Digestive Surgery, NIhon University School of Medicine

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 18438113 (View on PubMed)

Other Identifiers

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NUSM-CC-01

Identifier Type: -

Identifier Source: org_study_id