Recruiting NCT06356831
National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis, Cryotherapy Effect, Surgical, Radiology. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis [Time frame: at inclusion]
Secondary outcome measures (12)
- Characterize the epidemiology of parietal endometriosis nodules [Time frame: at 1 month, 6month 1year 2 years and 3 years after treatmeant]
- Characterize the epidemiology of parietal endometriosis nodules [Time frame: at inclusion]
- To assess the impact of hormone treatment on parietal endometriosis [Time frame: at 1 month, 6month 1year 2 years and 3 years after treatmeant]
- Assess the demographic distribution of parietal endometriosis [Time frame: At inclusion]
- Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis [Time frame: through study completion average 3 years]
- Evaluate the aesthetic impact of the treatments [Time frame: at 1 month after treatmeant]
- Assess the complication rate between the two groups [Time frame: 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 [Time frame: at inclusion]
- Assess the Severity of Complications according to Clavien Dindo for the surgeon [Time frame: at inclusion]
- Assess the recidivism rate at 3 years [Time frame: at 3 years]
- Assess the quality of life between the two groups with PGIC-7 questionnaire [Time frame: 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 EHP-5 questionnaire [Time frame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant]
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
- Patient with a nodule of primary or secondary malignant tumor origin
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 18 centers
- CHU bordeaux — Bordeau
- Clinique Tivoli — Bordeaux
- CHU Clermont Ferrand — Clermont-Ferrand
- CHI Creteil — Créteil
- Lyon Hôpital La Croix Rousse — Lyon
- Lyon Hôpital Sud — Lyon
- Lyon Louis Pradel — Lyon
- APHM-Hôpital Nord — Marseille
- … and 10 more centers
Identifiers
NCT: NCT06356831 · Endomecryo