National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis
- Conditions
- Cryotherapy EffectEndometriosisSurgicalRadiology
- Registration Number
- NCT06356831
- Lead Sponsor
- Centre Hospitalier Intercommunal Creteil
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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)
- 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
- Patient with a nodule of primary or secondary malignant tumor origin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis at inclusion number of Endometriosis 's patient treat by cryoablation or surgical
- Secondary Outcome Measures
Name Time Method Evaluate the aesthetic impact of the treatments at 1 month after treatmeant number of complication
Assess the complication rate between the two groups at 1 month, 6month 1year 2 years and 3 years after treatmeant number of complication between the two groups
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 average Patient Global Impression of Change PGIC-7 score : PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
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 average VAS score ( Analog Visual Scale) : VAS measures pain intensity on a scale from 0 to 10 (or sometimes from 0 to 100)
Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis through study completion average 3 years compare the size of of endometriosis nodules pre- and post-treatment
Assess the Severity of Complications according to Clavien Dindo for the surgeon at inclusion average of Complications according to Clavien Dindo for the surgeon
Assess the recidivism rate at 3 years at 3 years number of recidivism at 3 years
Characterize the epidemiology of parietal endometriosis nodules at inclusion average of parietal endometriosis nodules
To assess the impact of hormone treatment on parietal endometriosis at 1 month, 6month 1year 2 years and 3 years after treatmeant number of hormone treatment on parietal endometriosis
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 average of Complications according to SIR or CIRSE for Radiologists
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 average EHP-5 score ( Endometriosis Health Profil -5). Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable). Scores on the EHP-5 core and modular questionnaire then are transformed on a scale of 0 (indicating best possible health status) to 100 (indicating worst possible health status)
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 average of size of endometriosis nodules after cryoablation treatment
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 average of size endometriosis nodules after cryoablation treatment
Assess the demographic distribution of parietal endometriosis At inclusion compare the size of of endometriosis nodules pre- and post-treatment
Trial Locations
- Locations (18)
Lyon Hôpital La Croix Rousse
🇫🇷Lyon, France
Lyon Hôpital Sud
🇫🇷Lyon, France
Lyon Louis Pradel
🇫🇷Lyon, France
APHM-Hôpital Nord
🇫🇷Marseille, France
APHP-Hôpital de la Conception
🇫🇷Marseille, France
APHP-La Pitié
🇫🇷Paris, France
Clinique Tivoli
🇫🇷Bordeaux, France
CHU bordeaux
🇫🇷Bordeau, France
CHU Clermont Ferrand
🇫🇷Clermont-Ferrand, France
CHI Creteil
🇫🇷Créteil, France
CHU Montpellier
🇫🇷Montpellier, France
CHU Nime
🇫🇷Nîmes, France
AP-HP - Tenon
🇫🇷Paris, France
AP-HP Hôpital Européen Georges Pompidou
🇫🇷Paris, France
APHP Cochin-Port Royal
🇫🇷Paris, France
CHU Strasbourg
🇫🇷Strasbourg, France
CHU Toulouse
🇫🇷Toulouse, France
CH Valencienne
🇫🇷Valenciennes, France