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Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01187680
Enrollment
16
Registered
2010-08-24
Start date
2002-10-31
Completion date
2009-07-31
Last updated
2010-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Adhesion, Nos, Postoperative Adhesion

Keywords

Tissue adhesions, Laparoscopy

Brief summary

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

Interventions

DEVICESpraygel
DEVICEControl

Good surgical technique, no adhesion barrier

Sponsors

Onze Lieve Vrouwe Gasthuis
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* \>18 years * Undergoing gynecologic laparoscopy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
successful adhesion preventionAdhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.

Secondary

MeasureTime frameDescription
Adhesion sitesReduction in the number of sites covered with adhesions
LABS adhesion score

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026