Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

August 28, 2015 updated by: Won-Suk Lee, Gachon University Gil Medical Center
The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of GI 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Guardix
6g per body
Procedure: Guardix
Applying 6g of guardix during abdominal surgery
Other Names:
  • Guardix, Sami pharmaceutical company
  • Seprafilm
Procedure: Seprafilm
Applying 1 sheet of seprafilm during abdominal surgery
Active Comparator: Seprafilm
1 sheet per body
Procedure: Guardix
Applying 6g of guardix during abdominal surgery
Other Names:
  • Guardix, Sami pharmaceutical company
  • Seprafilm
Procedure: Seprafilm
Applying 1 sheet of seprafilm during abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ileus rate
Time Frame: within 60 days
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
within 60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse effect rate
Time Frame: within 60 days
within 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDIRB2013-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patient Under Going Colorectal and Stomach Cancer Surgery

Clinical Trials on Guardix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe