Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year

• Conditions: Endometriosis, Adhesive

• Registration Number: NCT02612818
• Lead Sponsor: Nordic Pharma SAS

Brief Summary

Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.

The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-23
• Study Start: 2015-11-24
• Study First Posted: 2015-11-24
• Status Verified: 2017-07
• Primary Completion: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 364

Inclusion Criteria

• Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
• Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
• Patients accepting and able to update a questionnaire in French.
• Informed patients who agree to computerised processing of their medical data and their right of access and rectification.

Read More

Exclusion Criteria

• Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
• Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
• Patients not wishing to become pregnant.
• Patients participating or having participated during the previous month in a gynaecological clinical trial.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fertility	One year after the baseline visit (i.e. celioscopy)	rate of pregnancy women
Change on the clinical signs	At 2 months and one year after the baseline visit (i.e. celioscopy)	The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.).

Trial Locations

Locations (1)

Nordic Pharma; 🇫🇷 Paris, France