This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

This study has been terminated.
(Financial and organisational reasons)
Onze Lieve Vrouwe Gasthuis
Information provided by:
Radboud University Identifier:
First received: July 19, 2010
Last updated: December 28, 2010
Last verified: August 2010
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01187680

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 Identifier: NCT01187680     History of Changes
Other Study ID Numbers: RU-RTB-0002
Study First Received: July 19, 2010
Last Updated: December 28, 2010

Keywords provided by Radboud University:
Tissue adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Pathologic Processes processed this record on August 18, 2017