Bioresorbable Membrane to Reduce Postoperative Small Bowe... | NCT00529412

Studies
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

NCT00529412

Sponsor

Nihon University

Status

Completed

Last Update Posted

Sep 14, 2007Estimated

Enrollment

150Actual

Phase

Phase 3

Conditions

Gastric Cancer

Interventions

Seprafilm

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Sep 13, 2007

First Submission Date that Met QC Criteria

Sep 13, 2007

First Posted Date

Sep 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2007

Last Update Posted Date

Sep 14, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	No Intervention	no Seprafilm	Other: Seprafilm
Seprafilm	Active Comparator		Other: Seprafilm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seprafilm	Other	two sheets per body	Seprafilm control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
intraoperative and postoperative morbidity and mortality.		3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

79 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tadatoshi Takayama, MD, PhD	Department of Digestive Surgery, Nihon University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Digestive Surgery, NIhon University School of Medicine		Tokyo		173-8610	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18438113	Derived	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.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms