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

NCT ID: NCT02612818

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-24

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Endometriosis, Adhesive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Coelioscopy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nordic Pharma SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène HERMAN-DEMARS, MD

Role: STUDY_DIRECTOR

Nordic Pharma

Locations

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Nordic Pharma

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ENDHY

Identifier Type: -

Identifier Source: org_study_id

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