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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02612818
Acronym
ENDHY
Enrollment
364
Registered
2015-11-24
Start date
2015-11-24
Completion date
2019-05-31
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Adhesive

Keywords

coelioscopy

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.

Interventions

DEVICECoelioscopy

Sponsors

Nordic Pharma SAS
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change on the clinical signsAt 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.).
FertilityOne year after the baseline visit (i.e. celioscopy)rate of pregnancy women

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026