Back to resultsEfficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy
Primary Purpose
Postoperative Adhesion, Peritoneal Adhesion, Nos
Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Spraygel
Control
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Adhesion focused on measuring Tissue adhesions, Laparoscopy
Eligibility Criteria
Inclusion Criteria:
- >18 years
- Undergoing gynecologic laparoscopy
Exclusion Criteria:
- Suspected malignancy
- Incomplete adhesiolysis during initial laparoscopy
- Pregnancy
- Lactating
- Stage IV endometriosis
Sites / Locations
- Onze Lieve Vrouwe Gasthuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spraygel
Control
Arm Description
Outcomes
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
Full Information
NCT ID
NCT01187680
First Posted
July 19, 2010
Last Updated
December 28, 2010
Sponsor
Radboud University Medical Center
Collaborators
Onze Lieve Vrouwe Gasthuis
1. Study Identification
Unique Protocol Identification Number
NCT01187680
Brief Title
Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy
Official Title
Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
Financial and organisational reasons
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Onze Lieve Vrouwe Gasthuis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Adhesion, Peritoneal Adhesion, Nos
Keywords
Tissue adhesions, Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spraygel
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Spraygel
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Good surgical technique, no adhesion barrier
Primary Outcome Measure Information:
Title
successful adhesion prevention
Description
Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.
Secondary Outcome Measure Information:
Title
LABS adhesion score
Title
Adhesion sites
Description
Reduction in the number of sites covered with adhesions
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years
Undergoing gynecologic laparoscopy
Exclusion Criteria:
Suspected malignancy
Incomplete adhesiolysis during initial laparoscopy
Pregnancy
Lactating
Stage IV endometriosis
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy
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