Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

December 28, 2010 updated by: Radboud University Medical Center

Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study

The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

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

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Onze Lieve Vrouwe Gasthuis

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • >18 years
  • Undergoing gynecologic laparoscopy

Exclusion Criteria:

  • Suspected malignancy
  • Incomplete adhesiolysis during initial laparoscopy
  • Pregnancy
  • Lactating
  • Stage IV endometriosis

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Device: Control
Good surgical technique, no adhesion barrier
Experimental: Spraygel
Device: Spraygel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
successful adhesion prevention
Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.

Secondary Outcome Measures

Outcome Measure
Measure Description
LABS adhesion score
Adhesion sites
Reduction in the number of sites covered with adhesions

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

Onze Lieve Vrouwe Gasthuis

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

October 1, 2002

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 29, 2010

Last Update Submitted That Met QC Criteria

December 28, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-RTB-0002

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.

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