跳至主要内容
临床试验/NCT05779462
NCT05779462招募中不适用

Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
1
主要终点
the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI

研究概览

简要总结

Endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age. There is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult. It therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented. The clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively. The persistence of hypo-mobility could also help to understand treatment failures.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient referred for suspected pelvic endometriosis requiring pelvic MRI
  • Female, nulliparous,
  • patient with signed written consent, patient with health insurance,
  • patient willing to comply with all study procedures and duration

排除标准

  • BMI > 35,
  • history of hereditary collagen and elastic tissue disease,
  • history of pelviperitonitis,
  • history of major pelvic surgery,
  • inability to receive informed information,
  • inability to participate in the entire study,
  • lack of social security coverage,
  • refusal to sign consent

结局指标

主要结局

the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI

时间窗: Baseline

次要结局

  • the statistical association between the symptoms of patients with endometriosis and the mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort during dynamic MRI.(Baseline)
  • the measurement of variation in mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort between the initial dynamic MRI of patients with(Baseline)
  • the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI.(Baseline)
  • the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI.(Baseline)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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