3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Score on SF 36 psychical health survey 6 weeks after surgery
研究概览
简要总结
Background:
No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.
Objective:
To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.
Design:
Investigator-initiated, blinded, randomised controlled trial.
Intervention description:
Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.
Trial size Roskilde/Herlev Hospital, Denmark:
200 patients in each arm of the 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.
排除标准
- •Women not suitable for laparoscopic hysterectomy including:
- •Ultrasound appraisal of uterus weight > 1000 gram
- •Need for prolapse surgery and therefore indication for vaginal hysterectomy.
- •Inability to give informed consent
研究组 & 干预措施
2-Dimensional laparoscopic hysterectomy
traditional 2-D laparoscopy
干预措施: 2-D laparoscopy (Device)
3-Dimensional laparoscopic hysterectomy
experimental 3-D laparoscopy
干预措施: 3-D laparoscopy (Device)
结局指标
主要结局
Score on SF 36 psychical health survey 6 weeks after surgery
时间窗: 6 weeks
Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively.
时间窗: 3 days
次要结局
- Operative time(4 hours)
- Major complications during the operation, postoperative complications(6 weeks)
- Minor complications during the operation, postoperative complications(6 weeks)
- Score on SF 36 mental health survey 6 weeks after surgery(6 weeks)
- Length of hospital stay(6 weeks)
研究者
Elise Hoffmann
MD
Zealand University Hospital