Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

Postoperative Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01187680
• Other study ID #: RU-RTB-0002
• Status: Terminated
• Phase: Phase 4
• First received: July 19, 2010
• Last updated: December 28, 2010
• Start date: October 2002
• Est. completion date: July 2009

Study information

• Verified date: August 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• >18 years

• Undergoing gynecologic laparoscopy

Exclusion Criteria:

• Suspected malignancy

• Incomplete adhesiolysis during initial laparoscopy

• Pregnancy

• Lactating

• Stage IV endometriosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peritoneal Adhesion, Nos
• Postoperative Adhesion
• Tissue Adhesions

Intervention

Device:
• Spraygel

• Control
Good surgical technique, no adhesion barrier

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful adhesion prevention	Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.		No
Secondary	LABS adhesion score			No
Secondary	Adhesion sites	Reduction in the number of sites covered with adhesions		No