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NCT Number: NCT06356831

National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

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

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Key information

Conditions

Endometriosis Cryotherapy Effect Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Radiology Surgical Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU bordeaux, Bordeau, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Characterize the epidemiology of parietal endometriosis nodules

    Time frame: at inclusion

    average of parietal endometriosis nodules

  3. 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

  4. Assess the demographic distribution of parietal endometriosis

    Time frame: At inclusion

    compare the size of of endometriosis nodules pre- and post-treatment

  5. 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

  6. Evaluate the aesthetic impact of the treatments

    Time frame: at 1 month after treatmeant

    number of complication

  7. 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

  8. 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

  9. 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

  10. Assess the recidivism rate at 3 years

    Time frame: at 3 years

    number of recidivism at 3 years

  11. 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 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."

  12. 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 ( 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)

  13. Assess the quality of life between the two groups with asses VAS questionnaire

    Time frame: 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)

  14. 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

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Léo Razakamanantsoa, Dr

CONTACT

[email protected]

0157023567

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: Endomercyo

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 10, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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