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Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

This study has been terminated.
(Financial and organisational reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187680
First Posted: August 24, 2010
Last Update Posted: December 29, 2010
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.
Collaborator:
Onze Lieve Vrouwe Gasthuis
Information provided by:
Radboud University
  Purpose
The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.

Condition Intervention Phase
Postoperative Adhesion Peritoneal Adhesion, Nos Device: Spraygel Device: Control Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

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


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


Enrollment: 16
Study Start Date: October 2002
Study Completion Date: July 2009
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spraygel Device: Spraygel
Active Comparator: Control Device: Control
Good surgical technique, no adhesion barrier

  Eligibility

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
Criteria

Inclusion Criteria:

  • >18 years
  • Undergoing gynecologic laparoscopy

Exclusion Criteria:

  • Suspected malignancy
  • Incomplete adhesiolysis during initial laparoscopy
  • Pregnancy
  • Lactating
  • Stage IV endometriosis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01187680


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

Responsible Party: E. Bakkum, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01187680     History of Changes
Other Study ID Numbers: RU-RTB-0002
First Submitted: July 19, 2010
First Posted: August 24, 2010
Last Update Posted: December 29, 2010
Last Verified: August 2010

Keywords provided by Radboud University:
Tissue adhesions
Laparoscopy

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes