Abdominal Versus Vaginal Uterine Bisection for Retrieval of Large Uteri During Laparoscopic Hysterectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Retrieval time of uterus
研究概览
简要总结
Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri
详细描述
Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.
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
- Single (Participant)
盲法说明
Closed envelopes containing allocations
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •large uterus ≥ 12weeks,
- •benign pathology,
- •mobile uterus
- •BMI less than 30kg/m2
排除标准
- •unfit for laparoscopy,
- •Extensive pelvic adhesions,
- •Extensive endometriosis
- •malignancy
- •virgin cases
研究组 & 干预措施
Study group
Vaginal bisection of uterus
干预措施: Vaginal bisection (Procedure)
Control group
Abdominal bisection
干预措施: Abdominal bisection (Procedure)
结局指标
主要结局
Retrieval time of uterus
时间窗: 6 months
Time from end of colpotomy to extraction of uterus
Blood loss
时间窗: 6 months
Amount of blood in suction
次要结局
- Injury of other organs(6 months)
研究者
Ayman S Dawood, MD
Assistant professor
Tanta University