Cryotherapy Effect, Endometriosis, Radiology, Surgical
Conditions
Keywords
endometriosis, Cryo ablation, Surgical operation, radiology
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.
Interventions
None listed
Sponsors
Centre Hospitalier Intercommunal Creteil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 demographic distribution of parietal endometriosis | At inclusion | compare the size of of endometriosis nodules pre- and post-treatment |
| 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 |
| 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 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 |
| Characterize the epidemiology of parietal endometriosis nodules | at 1 month, 6month 1year 2 years and 3 years after treatmeant | average of parietal endometriosis nodules |
| Assess the recidivism rate at 3 years | at 3 years | number of recidivism at 3 years |
| 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 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) |
| 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 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 Severity of Complications according to Clavien Dindo for the surgeon | at inclusion | average of Complications according to Clavien Dindo for the surgeon |
Countries
France
Contacts
Primary ContactLéo Razakamanantsoa, Dr
Outcome results
None listed