NCT06356831招募中不适用
National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis
研究概览
简要总结
National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis
时间窗: at inclusion
number of Endometriosis 's patient treat by cryoablation or surgical
次要结局
- 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)
- 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)
- Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis(through study completion average 3 years)
- Assess the complication rate between the two groups(at 1 month, 6month 1year 2 years and 3 years after treatmeant)
- Assess the Severity of Complications according to Clavien Dindo for the surgeon(at inclusion)
- Assess the recidivism rate at 3 years(at 3 years)
- Characterize the epidemiology of parietal endometriosis nodules(at inclusion)
- To assess the impact of hormone treatment on parietal endometriosis(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(at inclusion)
- 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)
- Evaluate the aesthetic impact of the treatments(at 1 month after treatmeant)
- 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)
- 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)
- Assess the demographic distribution of parietal endometriosis(At inclusion)
研究者
研究点 (18)
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