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Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier

NCT02165917 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-11-03

No results posted yet for this study

Summary

Endometriosis is a common disease of women in the reproductive age and is an important cause for female infertility. Endometriosis is often associated with the development of adhesions which further compromises the fertility of the affected women. The main purpose of this study is to investigate the pregnancy rate one year after excision of endometriosis and application of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the patients will receive traditional endometriosis treatment with the excision of the endometriotic lesions only. The other half will additionally receive a gel which can reduce adhesion formation (Hyalobarrier®). Further study objective is the investigation in the development of different types of endometriosis-associated pain over a period of one year. Potential study participants are women with endometriosis-associated pain and with a desire to have children. It will be investigated in the study if the use of Hyalobarrier® will result in a higher pregnancy rate due to reduced adhesion development.

Conditions

  • Endometriosis

Interventions

PROCEDURE

Excision plus hyaluronic acid gel

Excision of endometriosis foci by laparoscopic standard methods followed by an application of 10 cc Hyaluronic acid gel, in order to prevent postsurgical adhesions.

PROCEDURE

Excision only

Excision of endometriosis foci by laparoscopic standard methods only.

Sponsors & Collaborators

  • Pius-Hospital Oldenburg

    lead OTHER

Principal Investigators

  • Rudy L De Wilde, Professor · Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02165917 on ClinicalTrials.gov