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临床试验/NCT01949597
NCT01949597撤回不适用

Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen

Institut Universitari Dexeus1 个研究点 分布在 1 个国家开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Recurrences

研究概览

简要总结

The recurrence of endometriosis after surgery a formidable challenge for the gynecologist. Recurrence rates reported in the literature are very high, being 21.5% at 2 years and 40-50% at 5 years. Several theories attempt to explain these high figures. The three most widely accepted are:

  • The presence of residual endometriotic tissue or residual endometriotic cells not completely eradicated during surgery
  • The growth of undetected microscopic endometriosis during surgery
  • The development of endometriotic lesions de novo Patients with symptomatic endometriosis diagnosed by ultrasound or MRI and suitable for surgery will participate in the study. The surgical specimens sent for pathology from bladder, vagina, uterosacral, sigma or rectum will be properly marked for studying the presence of endometriosis.

详细描述

Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for deep endometriosis will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study.

Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with symptomatic endometriosis superior to 6 in a visual scale (VAS; Huskisson, 1974)diagnosed by ultrasound or MRI and suitable for laparoscopic surgery

排除标准

  • previous surgeries for deep endometriosis
  • Non complete surgery

结局指标

主要结局

Recurrences

时间窗: Two years after surgery

Evaluate clinical recurrence rate of endometriosis after complete surgery

次要结局

未报告次要终点

研究者

发起方
Institut Universitari Dexeus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignacio Rodriguez MSc

Epidemiologist

Institut Universitari Dexeus

研究点 (1)

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