Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.
详细描述
Research Questions:
Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?
Research Hypothesis:
In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The presence of perimenopausal bleeding
- •Early stage endometrial carcinoma.
- •Endometrial hyperplasia with/without atypia.
排除标准
- •Obese patients i.e., BMI< 29 k.g/m
- •Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
- •Presence of adnexal mass.
- •End stage endometrial carcinoma stage 3 & 4.
研究组 & 干预措施
Total Laparoscopic Hysterectomy
The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.
干预措施: Hysterectomy (Procedure)
Total Abdominal hysterectomy
The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.
干预措施: Hysterectomy (Procedure)
结局指标
主要结局
Operative time
时间窗: From skin incision till closure of the vault "up to 4 hours".
Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.
次要结局
- Hospital stay(From admission to the hospital until the home discharge "up to 1 week".)
- Blood transfusion(From admission to the hospital until the home discharge "up to 1 week".)
- Postoperative pain(8 hours after the end of operation.)
- Incidence of operative complications(During operation.)
- Blood loss(From skin incision start until skin suturing is finished "up to 4 hours".)
- Incidence of postoperative complications(Up to 1 week postoperative.)
研究者
Rania Gamal Anwar Elskaan
Assistant Lecturer
Ain Shams Maternity Hospital