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Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

This study has been terminated.
(Financial and organisational reasons)
Sponsor:
Collaborator:
Onze Lieve Vrouwe Gasthuis
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01187680
First received: July 19, 2010
Last updated: December 28, 2010
Last verified: August 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Further study details as provided by Radboud University:

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


Secondary Outcome Measures:
  • LABS adhesion score [ Designated as safety issue: No ]
  • Adhesion sites [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187680

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

No publications provided

Responsible Party: E. Bakkum, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01187680     History of Changes
Other Study ID Numbers: RU-RTB-0002
Study First Received: July 19, 2010
Last Updated: December 28, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Tissue adhesions
Laparoscopy

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013