NCT00529412

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at below P25 for phase_3 gastric-cancer

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

September 14, 2007

Status Verified

June 1, 2007

First QC Date

September 13, 2007

Last Update Submit

September 13, 2007

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • incidence of small bowel obstruction

    3 years, more than 6 months after gastrectomy

Secondary Outcomes (1)

  • intraoperative and postoperative morbidity and mortality.

    3 years

Study Arms (2)

control

NO INTERVENTION

no Seprafilm

Other: Seprafilm

Seprafilm

ACTIVE COMPARATOR
Other: Seprafilm

Interventions

SeprafilmOTHER

two sheets per body

Seprafilmcontrol

Eligibility Criteria

AgeUp to 79 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of gastric cancer
  • Operable

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Digestive Surgery, NIhon University School of Medicine

Tokyo, 173-8610, Japan

Location

Related Publications (1)

  • 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.

    PMID: 18438113DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Seprafilm

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Tadatoshi Takayama, MD, PhD

    Department of Digestive Surgery, Nihon University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 14, 2007

Study Start

August 1, 2003

Study Completion

March 1, 2007

Last Updated

September 14, 2007

Record last verified: 2007-06

Locations

JP(1)