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临床试验/NCT06386276
NCT06386276招募中不适用

Surgical TReatment of Women With Deep ENDometriosis Infiltrating the Sigmoid Colon and/or the Rectum. A Monocentric Archive

Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年10月11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
250
试验地点
1
主要终点
To assess the rate of recurrence

研究概览

简要总结

TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age >/= 18 years;
  • presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.

排除标准

  • age <18 years:
  • presence of coexisting inflammatory bowel disease;
  • patients who have received previous pelvic radiotherapy.

结局指标

主要结局

To assess the rate of recurrence

时间窗: 10 years

Rate/percentage

To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection

时间窗: 10 years

Percentage

To assess the rate of conversion to open surgery

时间窗: 10 years

Rate/percentage

To assess the rate of endometriosis-free bowel resection margins

时间窗: 10 years

Rate/percentage

To assess the rate of complications

时间窗: 10 years

Rate/percentage

次要结局

  • To assess the operating time(10 years)
  • To assess the gastrointestinal function recovery(10 years)
  • To assess the reproductive outcomes(10 years)
  • To assess the intraoperative blood loss(10 years)
  • To assess the duration of hospital stay(10 years)

研究者

发起方
Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Falcone

Medical Doctor

Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.

研究点 (1)

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