National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

Centre Hospitalier Intercommunal Creteil18 sites in 1 country300 target enrollmentJune 15, 2024

ConditionsEndometriosis Cryotherapy Effect Surgical Radiology

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometriosis
Sponsor: Centre Hospitalier Intercommunal Creteil
Enrollment: 300
Locations: 18
Primary Endpoint: creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

Detailed Description

Patient who suffering of parietal endometriosis treat by cryoablation or chirurgical will be recorded in national registry. the patient will be follow during 3 years after treatement.

Registry

clinicaltrials.gov

Start Date

June 15, 2024

End Date

January 31, 2028

Last Updated

5 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Centre Hospitalier Intercommunal Creteil

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Presence of parietal endometriosis: with suggestive clinical and imaging criteria (MRI and ultrasound)
•Symptomatic parietal endometriosis (VAS \> 3 OR bothersome bleeding OR reported impact on quality of life)

Exclusion Criteria

•Endometriosis not affecting the anterior wall of the abdomen (as deep pelvic muscle: ilio-psoas, obturators, perineal, ischio-anal fossa)
•Minor patient (\< 18 years)
•Pregnant patient at any trimester
•Patient with hemostasis disorders (constitutional or acquired)
•Patient with systemic infection or localized scar infection upon inclusion.
•Patient with contraindications to MRI
•Female patient with a planned medical or surgical procedure for the duration of the study that may interfere with the proper conduct of the study.
•Patient unable to understand the information provided
•Patient who is not affiliated to the social security system
•Patient under curatorship or tutorship

Outcomes

Primary Outcomes

creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis

Time Frame: at inclusion

number of Endometriosis 's patient treat by cryoablation or surgical

Secondary Outcomes

Assess the quality of life between the two groups with PGIC-7 questionnaire(at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant)
Assess the quality of life between the two groups with asses VAS questionnaire(at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant)
Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis(through study completion average 3 years)
Assess the complication rate between the two groups(at 1 month, 6month 1year 2 years and 3 years after treatmeant)
Assess the Severity of Complications according to Clavien Dindo for the surgeon(at inclusion)
Assess the recidivism rate at 3 years(at 3 years)
Characterize the epidemiology of parietal endometriosis nodules(at inclusion)
To assess the impact of hormone treatment on parietal endometriosis(at 1 month, 6month 1year 2 years and 3 years after treatmeant)
Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists(at inclusion)
Assess the quality of life between the two groups with asses EHP-5 questionnaire(at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant)
Evaluate the aesthetic impact of the treatments(at 1 month after treatmeant)
Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment(at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant)
Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment(at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant)
Assess the demographic distribution of parietal endometriosis(At inclusion)