Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

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. Identifier: NCT01187680
Recruitment Status : Terminated (Financial and organisational reasons)
First Posted : August 24, 2010
Last Update Posted : December 29, 2010
Onze Lieve Vrouwe Gasthuis
Information provided by:
Radboud University

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

Condition or disease Intervention/treatment Phase
Postoperative Adhesion Peritoneal Adhesion, Nos Device: Spraygel Device: Control Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study
Study Start Date : October 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
U.S. FDA Resources

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

Primary Outcome Measures :
  1. successful adhesion prevention
    Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.

Secondary Outcome Measures :
  1. LABS adhesion score
  2. Adhesion sites
    Reduction in the number of sites covered with adhesions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >18 years
  • Undergoing gynecologic laparoscopy

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01187680

Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord-Holland, Netherlands
Sponsors and Collaborators
Radboud University
Onze Lieve Vrouwe Gasthuis

Responsible Party: E. Bakkum, Onze Lieve Vrouwe Gasthuis Identifier: NCT01187680     History of Changes
Other Study ID Numbers: RU-RTB-0002
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: December 29, 2010
Last Verified: August 2010

Keywords provided by Radboud University:
Tissue adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Pathologic Processes