Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year (ENDHY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02612818|
Recruitment Status : Unknown
Verified July 2017 by Nordic Pharma SAS.
Recruitment status was: Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : August 1, 2018
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.
|Condition or disease||Intervention/treatment|
|Endometriosis, Adhesive||Device: Coelioscopy|
|Study Type :||Observational|
|Actual Enrollment :||364 participants|
|Official Title:||Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year|
|Actual Study Start Date :||November 24, 2015|
|Actual Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||May 2019|
- Change on the clinical signs [ Time Frame: 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.).
- Fertility [ Time Frame: One year after the baseline visit (i.e. celioscopy) ]rate of pregnancy women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612818
|Paris, France, 75007|
|Study Director:||Hélène HERMAN-DEMARS, MD||Nordic Pharma|