Endometriosis, Adhesive Clinical Trial
— ENDHYOfficial title:
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
| Verified date | July 2017 |
| Source | Nordic Pharma SAS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 364 |
| Est. completion date | May 2019 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Nordic Pharma | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Nordic Pharma SAS |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change on the clinical signs | 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.). | At 2 months and one year after the baseline visit (i.e. celioscopy) | |
| Primary | Fertility | rate of pregnancy women | One year after the baseline visit (i.e. celioscopy) |