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Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

NCT ID: NCT01187680

Last Updated: 2010-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Postoperative Adhesion Peritoneal Adhesion, Nos

Keywords

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Tissue adhesions Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Spraygel

Group Type EXPERIMENTAL

Spraygel

Intervention Type DEVICE

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

Good surgical technique, no adhesion barrier

Interventions

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Spraygel

Intervention Type DEVICE

Control

Good surgical technique, no adhesion barrier

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>18 years
* Undergoing gynecologic laparoscopy

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Onze Lieve Vrouwe Gasthuis

Locations

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Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RU-RTB-0002

Identifier Type: -

Identifier Source: org_study_id