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临床试验/NCT06220253
NCT06220253尚未招募不适用

Comparison of Learning Curves for Two Different Techniques in Vaginal Hysterectomy: Traditional Versus Minimally Invasive Bipolar Coagulation Technique

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Learning curve comparison

研究概览

简要总结

Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.

详细描述

This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.

Patients will be randomized 1:1 in two groups:

  1. Study group: bipolar coagulation technique
  2. Comparison group: reabsorbable stitches The primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women.

Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.

The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Women aged >18 years
  • Genital prolapse > II degree in accordance with the "POP-Q System" eligible for vaginal hysterectomy
  • Understanding and signing of informed consent for surgical procedure

排除标准

  • Need for simultaneous bilateral adnexectomy
  • Previous cesarian section
  • Patients with abdominal laparoscopic or laparotomy history
  • Patients with malignant pathology and/or adnexal pathology
  • Confirmed or presumed pregnancy

结局指标

主要结局

Learning curve comparison

时间窗: immediate post operative time

The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique.

次要结局

  • Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.(3 days after the surgical procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Salvatore

Principal Investigator

IRCCS San Raffaele

研究点 (2)

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