Clinical trial NCT06356831: National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis
Official title: National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Cryotherapy Effect
Surgical
Radiology
Keywords: endometriosis
Cryo ablation
Surgical operation
radiology
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with endomecriosis at least 18 years of age who will be oer are treate by cryo ablation or surgical treatement

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.

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

Primary outcomes:
measure: creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis
timeFrame: at inclusion
Secondary outcomes:
measure: Characterize the epidemiology of parietal endometriosis nodules
timeFrame: at 1 month, 6month 1year 2 years and 3 years after treatmeant
measure: Characterize the epidemiology of parietal endometriosis nodules
timeFrame: at inclusion
measure: To assess the impact of hormone treatment on parietal endometriosis
timeFrame: at 1 month, 6month 1year 2 years and 3 years after treatmeant
measure: Assess the demographic distribution of parietal endometriosis
timeFrame: At inclusion
measure: Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis
timeFrame: through study completion average 3 years
measure: Evaluate the aesthetic impact of the treatments
timeFrame: at 1 month after treatmeant
measure: Assess the complication rate between the two groups
timeFrame: at 1 month, 6month 1year 2 years and 3 years after treatmeant
measure: Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists
timeFrame: at inclusion
measure: Assess the Severity of Complications according to Clavien Dindo for the surgeon
timeFrame: at inclusion
measure: Assess the recidivism rate at 3 years
timeFrame: at 3 years
measure: Assess the quality of life between the two groups with PGIC-7 questionnaire
timeFrame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
measure: Assess the quality of life between the two groups with asses EHP-5 questionnaire
timeFrame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
measure: Assess the quality of life between the two groups with asses VAS questionnaire
timeFrame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
measure: Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment
timeFrame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
measure: Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment
timeFrame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeau
country: France
facility: CHU bordeaux
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Créteil
country: France
facility: CHI Creteil
city: Lyon
country: France
facility: Lyon Hôpital La Croix Rousse
city: Lyon
country: France
facility: Lyon Hôpital Sud
city: Lyon
country: France
facility: Lyon Louis Pradel
city: Marseille
country: France
facility: APHM-Hôpital Nord
city: Marseille
country: France
facility: APHP-Hôpital de la Conception
city: Montpellier
country: France
facility: CHU Montpellier
city: Nîmes
country: France
facility: CHU Nime
city: Paris
country: France
facility: AP-HP - Tenon
city: Paris
country: France
facility: AP-HP Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: APHP Cochin-Port Royal
city: Paris
country: France
facility: APHP-La Pitié
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Valenciennes
country: France
facility: CH Valencienne
Study officials:
affiliation: CHIC
name: Léo RAZAKAMAMANTSOA
role: PRINCIPAL_INVESTIGATOR
References: