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临床试验/NCT06976905
NCT06976905尚未招募不适用

Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
34
试验地点
1
主要终点
Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hours

研究概览

简要总结

To compare between myoma screw and uterine manipulator in manipulation of large uterus in total laparoscopic hysterectomy

详细描述

Hysterectomy is performed on 1,500,000 women worldwide each year to treat benign disorders such leiomyoma, prolapse, and irregular bleeding, as well as gynecologic malignancies. Prior to the introduction of the first laparoscopic procedures in the late 1980s, hysterectomy was traditionally accomplished by laparotomy or the vaginal route. Total laparoscopic hysterectomy (TLH) became the most commonly used hysterectomy technique in the last ten years, especially in developed nations, because laparoscopic hysterectomy has some advantages over other hysterectomy types, including high patient satisfaction, an earlier return to work, less blood loss, the ability to diagnose and treat other pelvic diseases, and the ability to maintain thorough intraperitoneal haemostasis.

However, there are some drawbacks to TLH as well, such as its expensive cost, lengthier operating time, and requirement for advanced technological instruments including uterine manipulators (UM) and sealing devices.

In order to facilitate colpotomy by defining the cervicovaginal junction and enable safer dissection around the cervix, the main goal of utilising a UM is to extend the distance between the cervix and ureter.There isn't enough clinical data in the literature to say whether using UM meets these expectations, though.Additionally, the use of UMs has been linked to a number of specific problems, such as uterine rupture, intestinal perforation, and vaginal wall laceration.UMs are also not appropriate in certain cases, such as vaginal stenosis, anatomical differences that make it difficult to identify the uterus or cervix, and patients who refuse vaginal penetration because they are virgins. There is still no "optimal UM" that is consistently safe, effective, and economical, despite the fact that numerous UMs have been developed in recent decades.

Some studies have suggested alternatives including the use of certain sutures, gripping forceps, or myoma screws (MS) as answers to the issues that arise with the use of UM. When performing a myomectomy using the vaginal method, laparotomy, or laparoscopy, the MS is a conventional, reusable instrument. MSs are renowned for their ability to deliver a powerful three-dimensional traction force. Additionally, using MS does not require specialised knowledge like UMs do.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Large uterus with fundal level 12-24w diagnosed by TAS( Transabdominal Ultrasound)/TVUS(Transvaginal ultrasound)
  • •Adenomyosis

排除标准

  • •BMI more than 40
  • •patients with contraindication for laparscopic surgery e.g cardiac and cirrhotic patients

研究组 & 干预措施

Myoma screw usage in total laparoscopic hysterectomy in large uterus

Experimental

Using myoma screw from abdominal approach in manipulation Instead of traditional uterine mani Pulator

干预措施: Total laparoscopic hysterectomy (Procedure)

Uterine manipulator in total laparoscopic hysterectomy in large uterus

Experimental

Using traditional uterine manipulator via vagina in uterine manipulation

干预措施: Total laparoscopic hysterectomy (Procedure)

结局指标

主要结局

Comparison between Magneshkar uterine manipulator and myoma screw in operation time in hours

时间窗: During surgery in hours

Using myoma screw as a manipulator in total laparoscopic hysterectomy

次要结局

  • Volume of blood loss in ml liters(Day 1)

研究者

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

Mona Gamil

Resident

Kafrelsheikh University

研究点 (1)

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