Vaginal Hysterectomy Versus Laparoscopically Assisted Hysterectomy for Large Uteri ( A Pilot Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Operative time of the procedure
研究概览
简要总结
The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes
详细描述
Study setting : Ain Shams University Maternity Hospital Study Design : Pilot prospective randomized clinical trial Study population: The patients will be recruited from women presenting to the outpatient clinic of Ain Shams University Maternity Hospital planned to undergo hysterectomy for benign cause according to inclusion/ exclusion criteria which will be mentioned later.
Study duration : the study will be carried out during the period from August 2014 to August 2016.
Sample size: total of 50 cases will be included in the study to be divided into two groups, the first group will undergo vaginal hysterectomy and the second will undergo Laparoscopic assisted vaginal hysterectomy.
intervention: after approval of the ethical committee, a detailed explanation of the procedure will be informed to the participant and after her approval to involve in the study, an informed written consent will be taken. Detailed medical history will be obtained from all participants recruited in the study along with complete clinical examination and necessary laboratory and radiological investigations. Each patient will have a case record form in which the data regarding history, examination, investigations, operation costs and postoperative events will be recorded
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 70 years.
- •Uterine weight more than 280gm. the weight will be estimated sonographically using algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)= 50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the dome of the fundus to the level of the external os and (W) is the maximum width of the uterus at the level of the cornua and (AP) is the anteroposterior diameter of the uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine length.
- •Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.
排除标准
- •Patients medically unfit for laparoscopy as severely compromised cardiac patients.
- •Obese patients (BMI>30).
- •Presence of endometriosis.
- •Previous myomectomy
- •Presence of adnexal mass
- •Known or suspected gynecological malignancy.
结局指标
主要结局
Operative time of the procedure
时间窗: Range from 90 minutes to 210 minutes
In case of vaginal hysterectomy, the operative time will be measured from the vaginal incision to closure of the vaginal vault. in cases of Laparoscopic assisted vaginal hysterectomy, the time will be measured from the introduction of the laparoscopic camera port till stitching the laparoscopic incisions after ensuring adequate hemostasis. the time of any concomitant procedures was excluded
次要结局
- Postoperative Pain(the first 24hrs after the procedure)
- postoperative hospital stay(range from 24 hours to 168 hours)
- Postoperative complications(1 month after the procedure)
- Estimated intraoperative blood loss(the operative time of the procedure which range from 90 minutes to 210 minutes)
- Hospital costs(within the period of hospital admission which range from 2 to 8 days)
- intraoperative complications(the operative time of the procedure which range from 90 minutes to 210 minutes)
研究者
Ibrahim Mohamed Ibrahim Ali
lecturer in obstetrics and gynecology
Ain Shams Maternity Hospital