NCT02165917

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

Randomised, Controlled Clinical Study With Patients With Endometriosis and the Desire to Have Children - Comparison Between Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesionbarrier

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pius-Hospital Oldenburg · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Design: Prospective, monocentric, comparative, randomized, semi-blind. There will be 30 subjects in each arm, who will be followed 15 months after surgery. Half of the patients will receive standard laparoscopic excision of the endometriotic lesions only. The other half, after the excision of the endometriosis foci, will receive 10 cc of an antiadhesion agent which contents hyaluronic acid gel (Hyalobarrier®).The subjects will be hospitalized after surgery for at least 2 days. A Vas-Scala will be given to the subjects to estimate the pain before, after surgery and one year after treatment. The participants will record the values each three months after surgery. All subjects will be asked by telephone for the VAS-scala values and for pregnancy (Date of Initiation, clinical evolution) The participation ist voluntary and an Informed consent must be signed before surgery. Subjects are free to withdraw their consent anytime.

Conditions

• Endometriosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-06-18
• Last updated: 2015-11-03

Locations

1 site across 1 country: Germany