Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

Phase 4

Terminated

• Conditions: Postoperative Adhesion; Peritoneal Adhesion, Nos
• Interventions: Device: Spraygel; Device: Control

• Registration Number: NCT01187680
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-04
• Study Completion: 2009-07
• Study First Submitted: 2010-07-19
• Status Verified: 2010-08
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Last Update Submitted: 2010-12-28
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• >18 years
• Undergoing gynecologic laparoscopy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spraygel	Spraygel	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
successful adhesion prevention		Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.

Secondary Outcome Measures

Name	Time	Method
LABS adhesion score
Adhesion sites		Reduction in the number of sites covered with adhesions

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands