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Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00529412
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 14, 2007
Sponsor:
Information provided by:
Nihon University

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Other: Seprafilm Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
Study Start Date : August 2003
Actual Study Completion Date : March 2007

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: control
no Seprafilm
 Other: Seprafilm
two sheets per body
Active Comparator: Seprafilm Other: Seprafilm
two sheets per body


Outcome Measures
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Primary Outcome Measures :
  1. incidence of small bowel obstruction [ Time Frame: 3 years, more than 6 months after gastrectomy ]

Secondary Outcome Measures :
  1. intraoperative and postoperative morbidity and mortality. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529412


Locations
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Japan
Department of Digestive Surgery, NIhon University School of Medicine
Tokyo, Japan, 173-8610
Sponsors and Collaborators
Nihon University
Investigators
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Study Chair: Tadatoshi Takayama, MD, PhD Department of Digestive Surgery, Nihon University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00529412    
Other Study ID Numbers: NUSM-CC-01
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: September 14, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Stomach Neoplasms
Intestinal Obstruction
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Intestinal Diseases