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

NCT02165917 | Unknown Phase 4

• 1 other identifier: PHDW-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endometriosis; Adhesions; Hyalobarrier®; Hyaluronic acid; Antiadhesion agent; Adhesionbarrier; Pregnancy rate

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)

Secondary Outcomes (2)

• Endometriosis-associated pain

  The day before laparoscopy is performed

• Endometriosis-associated pain

  One year after completion of endometriosis treatment

Study Arms (2)

Excision only

PLACEBO COMPARATOR

Laparoscopic excision of endometriotic lesions followed by 3 month of GnRH-Analogue administration

Procedure: Excision only

Excision plus hyaluronic acid gel

ACTIVE COMPARATOR

Standard Laparoscopic excision of endometriotic lesions plus application of 10 cc of a hyaluronic acid gel (Hyalobarrier® ), followed by 3 month of GnRH-analogue administration

Procedure: Excision plus hyaluronic acid gel

Interventions

Excision plus hyaluronic acid gel PROCEDURE

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

Excision plus hyaluronic acid gel

Excision only PROCEDURE

Excision of endometriosis foci by laparoscopic standard methods only.

Excision only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are in good general health except for endometriosis related problems;
• Except for endometriosis, no existence of an obvious diseases which could cause chronic pain or which could cause abdominal pain;
• The participant must have a desire to have children;
• Participants must be able to give their consent and must understand the risks associated with a participation in the study;
• There must be a signed and dated informed consent which was accepted by the local ethic committee

You may not qualify if:

• Existent pregnancy including ectopic pregnancy;
• Identification of other causes for the discomfort;
• Chronic diseases, except endometriosis, which require continuous pain therapy;
• Previous application of GnRH analogues 6 month prior to study;
• Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;
• Planned additional general surgical procedures during the operation for removal of the endometriotic lesions;
• Absence of endometriosis at laparoscopy;
• Partial resection of the bowel or urinary bladder for removal of endometriosis

Sponsors & Collaborators

• Pius-Hospital Oldenburg: lead

Study Sites (1)

Pius-Hospital, Department of Gynecology, Obstetrics and Gynecological Oncology, Carl von Ossietzky University

Oldenburg, Lower Saxony, 26121, Germany

RECRUITING

MeSH Terms

Conditions

Endometriosis; Tissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudy L De Wilde, Professor

  Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudy L De Wilde, Professor

CONTACT

+49 441 229 1501; gyn-sekretariat@pius-hospital.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Dr. med.

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: June 18, 2014
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

DE (1)