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Trial record 1 of 1 for:    NCT02612818
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Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year (ENDHY)

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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Endometriosis, Adhesive Device: Coelioscopy

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Study Type : Observational
Actual Enrollment : 364 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.).

  2. Fertility [ Time Frame: One year after the baseline visit (i.e. celioscopy) ]
    rate of pregnancy women



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subsequent patients of procreation age having undergone a cœlioscopy for endometriosis, for whom a spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately, and meeting all of the selection criteria will be included in the study.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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France
Nordic Pharma
Paris, France, 75007
Sponsors and Collaborators
Nordic Pharma SAS
Investigators
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Study Director: Hélène HERMAN-DEMARS, MD Nordic Pharma
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Responsible Party: Nordic Pharma SAS
ClinicalTrials.gov Identifier: NCT02612818    
Other Study ID Numbers: ENDHY
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2017
Keywords provided by Nordic Pharma SAS:
coelioscopy
Additional relevant MeSH terms:
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Endometriosis
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes