National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis (Endomercyo)

April 4, 2024 updated by: Centre Hospitalier Intercommunal Creteil
National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis
Time Frame: at inclusion
number of Endometriosis 's patient treat by cryoablation or surgical
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize the epidemiology of parietal endometriosis nodules
Time Frame: at 1 month, 6month 1year 2 years and 3 years after treatmeant
average of parietal endometriosis nodules
at 1 month, 6month 1year 2 years and 3 years after treatmeant
Characterize the epidemiology of parietal endometriosis nodules
Time Frame: at inclusion
average of parietal endometriosis nodules
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
number of hormone treatment on parietal endometriosis
at 1 month, 6month 1year 2 years and 3 years after treatmeant
Assess the demographic distribution of parietal endometriosis
Time Frame: At inclusion
compare the size of of endometriosis nodules pre- and post-treatment
At inclusion
Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis
Time Frame: through study completion average 3 years
compare the size of of endometriosis nodules pre- and post-treatment
through study completion average 3 years
Evaluate the aesthetic impact of the treatments
Time Frame: at 1 month after treatmeant
number of complication
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
number of complication between the two groups
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
average of Complications according to SIR or CIRSE for Radiologists
at inclusion
Assess the Severity of Complications according to Clavien Dindo for the surgeon
Time Frame: at inclusion
average of Complications according to Clavien Dindo for the surgeon
at inclusion
Assess the recidivism rate at 3 years
Time Frame: at 3 years
number of recidivism at 3 years
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
average PGIC-7 score
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
average EHP-5 score
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 EVA questionnaire
Time Frame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
average EVA score
at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment
Time Frame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
average of size of endometriosis nodules after cryoablation treatment
at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment
Time Frame: at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant
average of size endometriosis nodules after cryoablation treatment
at inclusion,1 month, 6 months 1year 2 years and 3 years after treatmeant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endomecryo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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