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临床试验/NCT03228654
NCT03228654终止4 期

Electrosurgical Unipolar Vessel Sealing Versus Purohit Technique in Vaginal Hysterectomy . ( A Pilot Randomized Clinical Trial)

Ain Shams University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
10
试验地点
2
主要终点
Intraoperative blood loss

研究概览

简要总结

Hysterectomy is one of the most common surgical procedures in gynecologic practice. Inspiteof the development of alternative treatments, the incidence of hysterectomy doesn't appear to be declining. Routes for hysterectomy include abdominal, vaginal, laparoscopic or combined approaches.Vaginal hysterectomy is the method of choice for removal of the uterus in patients with benign gynecological diseases. A Cochrane review of surgical approaches to hysterectomy for benign gynecological diseases concluded that, wee possible vaginal hysterectomy should be performed in preference to abdominal hysterectomy.

详细描述

A pilot prospective randomized clinical trial will be conducted at Ain shams University Maternity Hospital during the period from August 2016 to August 2018.

A sample size of 50 cases will be recruited from women presenting to the outpatient gynecologic clinic of Ain Shams University Maternity Hospital planned to undergo vaginal hysterectomy for benign cause. selected patients should be in age group from 40 to 70 years. Uterus size should be < 12 weeks with absence of significant scarring in the pelvis from previous surgeries. Endometriosis, Adnexal mass, malignancy, thinned out cervix should be excluded. After approval of the ethical committee , a detailed explanation of the procedure will e informed to the participant & her approval to be involved in the study, an informed written consent will be taken. After that, included patients will be randomized into 2 groups each one include 25 patients. First group includes women who will undergo vaginal hysterectomy using monopolar electrocautery. Second group includes women who will undergo vaginal hysterectomy using Purohit's technique. Principles of Purohit technique are 1. Vaginal walls are incised by monopolar current(30-50W).2.A right angle forceps is used o elevate, hook, stretch, spread and retract all the lateral attacements of uterus & vessels from their posterior aspects; tissues are coagulated using bipolar current (45 W) and divided between the prongs of forceps. 3. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.

Meanwhile the principles for vaginal hysterectomy using unipolar electrocautery are 1.Vaginal walls are incised by monopolar current(40 W) 2.A curved Bulldog clamp is applied just 0.5 cm lateral to uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lteral border of the uterus medial to the artery with maximum thickness 1 cm. 3. Uterine vessels are individually secured. 4. conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for bipolar forceps and scissors.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • uterine size <12 weeks.
  • presence of benign cause for the hysterectomy e.g. fibroid uterus, perimenopausal beeding not responding to medical treatment or complex endometrial hyperplasia without atypia.
  • Absence of significant scarring in the pelvis from previous surgeries.

排除标准

  • Suspected or known gynecological malignancy.
  • uterine size >12 weeks.
  • Endometriosis
  • Presence of adnexal mass.
  • cervix flushed with the vagina.
  • presence of significant scarring in the pelvic area from previous surgery.

结局指标

主要结局

Intraoperative blood loss

时间窗: 5 minutes after end if the procedure

assessment of blood loss by assessing blood loss amount in suction bottle as well as soaked guzes and towels.

次要结局

  • Hospital stay(1 week after procedure)
  • operative time(5 minutes after end of the procedure)
  • postoperative pain(24 hours postoperative)

研究者

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

Ahmed Abass

Lecturer

Ain Shams University

研究点 (2)

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