CClinicalTrials.gg
Status unknownNCT02612818ENDHYUpdated Aug 1, 2018

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

An observational study in Endometriosis, Adhesive, sponsored by Nordic Pharma SAS. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-01.

Sponsored by Nordic Pharma SAS · Observational

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
364
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Endometriosis, Adhesive

Keywords

  • coelioscopy
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 364 is above the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Nordic Pharma SAS is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
364 participants (actual)
Patient registry
No

Interventions

  • DeviceCoelioscopy
06

What researchers measure

Primary outcomes

  1. 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.).

    Time frame: At 2 months and one year after the baseline visit (i.e. celioscopy)

  2. Fertility

    rate of pregnancy women

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

07

Study locations

1 site
  • Nordic Pharma
    Paris, 75007, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02612818
Lead sponsor
Nordic Pharma SAS
Responsible party
Sponsor
First posted
Nov 24, 2015
Start date
Nov 24, 2015
Primary completion
Jul 2018
Completion
May 2019 (estimated)
Last update
Aug 1, 2018

Study contacts

Hélène HERMAN-DEMARS, MD
study director · Nordic Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion