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Completed

NCT Number: NCT00529412

Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

Up to 79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Digestive Surgery, NIhon University School of Medicine

Tokyo, 173-8610, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seprafilm

Other

two sheets per body

Primary outcomes

  1. incidence of small bowel obstruction

    Time frame: 3 years, more than 6 months after gastrectomy

Secondary outcomes

  1. intraoperative and postoperative morbidity and mortality.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Nihon University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2007
First posted
Sep 14, 2007
Registry last updated
Sep 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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