UnknownPhase 4

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

Germany60 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women over 18 years with endometriosis-associated pain, like dysmenorrhea, dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only one criterion needs to be fulfilled for study inclusion); * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pregnancy rate

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

Trial details

NCT IDNCT02165917

SponsorPius-Hospital Oldenburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05

Contact for this trial

Rudy L De Wilde, Professor

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

View on ClinicalTrials.gov More Endometriosis trials