Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy
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
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
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
Mona Gamil
Resident
Kafrelsheikh University
