A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Operative Time (min)
研究概览
简要总结
The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.
详细描述
A prospective randomized open-label study was conducted. Women >18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.
Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus < 12 weeks, suspected malignancy and large adnexal masses (>5cm). Peri-operative outcomes were compared.
Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mobile uterus.
- •Uterine size up to 12 weeks gestation.
- •Benign lesions.
排除标准
- •Enlarged uterus > 12 weeks gestation.
- •Suspected malignancy.
- •Large adnexal masses.
研究组 & 干预措施
Total laparo hysterectomy
Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)
干预措施: Surgical procedure, Hysterectomy (Procedure)
Mini-lap hysterectomy
Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)
干预措施: Surgical procedure, Hysterectomy (Procedure)
结局指标
主要结局
Operative Time (min)
时间窗: Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)
Time in minutes taken for total hysterectomy
Estimated blood loss (mL)
时间窗: Through surgical intervention completion
Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values
次要结局
- Early postoperative complications(Within 30 days after operation)
研究者
Tarek Shokeir
Prof. Obstetrics & Gynecology
Mansoura University