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临床试验/NCT04237558
NCT04237558已完成不适用

Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer in Mansoura University Hospitals: A Randomized Clinical Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年4月1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
52
试验地点
2
主要终点
Duration of operation

研究概览

简要总结

This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy ,using bipolar vessel sealer,in cases of abnormal uterine bleeding in Mansoura University Hospital in order to reach the optimum technique for our locality

详细描述

Hysterectomy is the surgical removal of the uterus. It is the commonest major gynecological surgery, next to caesarean section, with millions of procedures performed annually throughout the world.Approximately 90% of hysterectomies are performed for benign conditions.

Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. The optimal route of hysterectomy for a patient will depend on the pathological nature, size and shape of the vagina and uterus, uterine descent, endometriosis and the likelihood of pelvic adhesions, adnexal masses, previous pelvic surgery, available hospital technology, devices and the surgeon's preference.

Approaches to hysterectomy may be broadly categorized into four options: abdominal hysterectomy (AH); vaginal hysterectomy (VH); laparoscopic hysterectomy (LH) where at least some of the operation is conducted laparoscopically and robotic-assisted hysterectomy (RH).Vaginal and laparoscopic procedures are considered "minimally invasive" surgical approaches because they do not require a large abdominal incision and, thus, typically are associated with shortened hospitalization and postoperative recovery times compared with open abdominal hysterectomy.

This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy, using bipolar vessel sealer, in cases of abnormal uterine bleeding in order to reach the optimum technique with lower cost to be easily applied to low resource settings.

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
None

入排标准

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

入选标准

  • Women assigned for performing hysterectomy for abnormal uterine bleeding due to benign pathology.
  • Uterine size by bimanual examination ≤14 weeks gestational size.
  • Cases with uterine volumes ≤ 400cm3 will be included in this study.

排除标准

  • Patients with BMI > 30kg/m2
  • Uteri > 14 weeks gestational size by bimanual examination or volume > 400cm3
  • Women with positive pap smear for CIN or endometrial biopsy with atypia or carcinoma.
  • Patient with other known body malignancy.
  • Patient with other pelvic pathology, endometriosis or pelvic abscesses.
  • Patients with abdominal scars.

结局指标

主要结局

Duration of operation

时间窗: From start of surgery up to 24 hours

Duration of operation

次要结局

  • Time of requiring analgesics(Until 24 hours postoperatively)
  • Number of requiring analgesics(Until 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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