Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

Phase 4TerminatedNCT01187680

Radboud University Medical Center16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Adhesion Peritoneal Adhesion, Nos

Interventions

SpraygelDEVICE

ControlDEVICE

Good surgical technique, no adhesion barrier

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>18 years * Undergoing gynecologic laparoscopy Exclusion Criteria: * Suspected malignancy * Incomplete adhesiolysis during initial laparoscopy * Pregnancy * Lactating * Stage IV endometriosis

Locations (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

successful adhesion prevention

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

Secondary Outcomes

LABS adhesion score

Adhesion sites

Reduction in the number of sites covered with adhesions

Data from ClinicalTrials.gov

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