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临床试验/NCT04522232
NCT04522232已完成不适用

Laparoscopic Hysterectomy With Prior Uterine Artery Ligation vs Conventional Laparoscopic Hysterectomy

National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
1
主要终点
blood loss

研究概览

简要总结

A randomized controlled trial was done on 127 women planned for TLH, and divided into two groups; group A includes women that underwent conventional TLH, and group B includes women that underwent TLH with prior uterine artery ligation at its origin. Both grouped were compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • any benign uterine pathology such as:
  • fibroid uterus
  • endometrial hyperplasia with failed hormonal therapy
  • DUB with failed medical and hormonal treatment
  • uterine prolapse.

排除标准

  • gynecologic malignancy
  • presence of contraindications to laparoscopy.

结局指标

主要结局

blood loss

时间窗: during the Laparoscopy

The total blood loss was calculated from the suction apparatus. No irrigation was used throughout the surgery until the total blood loss was calculated. Peritoneal lavage was done with normal saline solution.

operation time

时间窗: during the Laparoscopy

start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars

次要结局

  • intraoperative or postoperative complications(during the Laparoscopy and during the hospital stay (24 hours postoperative))

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mazen Abdel Rasheed

Principal Investigator

National Research Centre, Egypt

研究点 (1)

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