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临床试验/NCT05420662
NCT05420662已完成不适用

The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes in Abdominal Hysterectomy Operations

Kocaeli University2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
Vaginal Length Difference

研究概览

简要总结

If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is significantly shortened.

详细描述

In a classical abdominal hysterectomy, the Cardinal ligaments and the Sacrouterine ligaments are cut before the uterus leaves the vagina, and the vaginal cuff is cut deeper in the vagina over the cervix and separated from the vagina. During this procedure, the vaginal tissue in the Portio vaginalis comes out and causes a loss of vaginal length. If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is significantly shortened.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who underwent hysterectomy due to abnormal uterine bleeding
  • Myoma uteri, little than 5 cm which does not disrupt the uterine anatomy

排除标准

  • Myoma uteri, which disrupts the uterine anatomy
  • Intra-abdominal adhesions
  • Endometrial intraepithelial neoplasia
  • Endometrial cancer
  • Ovarian cancer
  • Cervical cancer

结局指标

主要结局

Vaginal Length Difference

时间窗: Preoperative one hour and postoperative one hour

The difference between preoperative and postoperative vaginal length will be calculated

次要结局

  • Operation time(One to two hours)

研究者

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

Şener Gezer

Assistant Professor

Kocaeli University

研究点 (2)

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