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

NCT02612818 | Unknown

• 1 other identifier: ENDHY
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis, Adhesive

Keywords

coelioscopy

Outcome Measures

Primary Outcomes (2)

• 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)

• Fertility

  rate of pregnancy women

  One year after the baseline visit (i.e. celioscopy)

Interventions

Coelioscopy DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordic Pharma SAS: lead

Study Sites (1)

Nordic Pharma

Paris, 75007, France

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hélène HERMAN-DEMARS, MD

  Nordic Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: November 24, 2015
• Primary Completion: July 1, 2018
• Study Completion: May 1, 2019
• Last Updated: August 1, 2018

Record last verified: 2017-07

Locations

FR (1)