National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

Endometriosis Clinical Trial

— Endomercyo  

Official title:

National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356831
• Other study ID #: Endomecryo
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Camille Young
• Phone: +33157022768
• Email: camille.young[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 31, 2028
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Endometriosis
• Radiology
• Surgical

Locations

Country	Name	City	State
France	CHU bordeaux	Bordeau
France	Clinique Tivoli	Bordeaux
France	CHU Clermont Ferrand	Clermont-Ferrand
France	CHI Creteil	Créteil
France	CHU de Lyon	Lyon
France	APHP Marseille	Marseill
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis	number of Endometriosis 's patient treat by cryoablation or surgical	at inclusion
Secondary	Characterize the epidemiology of parietal endometriosis nodules	average of parietal endometriosis nodules	at 1 month, 6month 1year 2 years and 3 years after treatmeant
Secondary	Characterize the epidemiology of parietal endometriosis nodules	average of parietal endometriosis nodules	at inclusion
Secondary	To assess the impact of hormone treatment on parietal endometriosis	number of hormone treatment on parietal endometriosis	at 1 month, 6month 1year 2 years and 3 years after treatmeant
Secondary	Assess the demographic distribution of parietal endometriosis	compare the size of of endometriosis nodules pre- and post-treatment	At inclusion
Secondary	Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis	compare the size of of endometriosis nodules pre- and post-treatment	through study completion average 3 years
Secondary	Evaluate the aesthetic impact of the treatments	number of complication	at 1 month after treatmeant
Secondary	Assess the complication rate between the two groups	number of complication between the two groups	at 1 month, 6month 1year 2 years and 3 years after treatmeant
Secondary	Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists	average of Complications according to SIR or CIRSE for Radiologists	at inclusion
Secondary	Assess the Severity of Complications according to Clavien Dindo for the surgeon	average of Complications according to Clavien Dindo for the surgeon	at inclusion
Secondary	Assess the recidivism rate at 3 years	number of recidivism at 3 years	at 3 years
Secondary	Assess the quality of life between the two groups with PGIC-7 questionnaire	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."	at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Secondary	Assess the quality of life between the two groups with asses EHP-5 questionnaire	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)	at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Secondary	Assess the quality of life between the two groups with asses VAS questionnaire	average VAS score ( Analog Visual Scale) : VAS measures pain intensity on a scale from 0 to 10 (or sometimes from 0 to 100)	at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Secondary	Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment	average of size of endometriosis nodules after cryoablation treatment	at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Secondary	Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment	average of size endometriosis nodules after cryoablation treatment	at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant