Micro-laparoscopic Versus Single-port Total Hysterectomy: a Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34 were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS and LESS.
详细描述
Between May 2011 and February 2012 a prospective randomized study was carried out at the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome-Italy.
Consenting patients scheduled to be submitted to a total laparoscopic hysterectomy for benign, pre-malignant and malignant disease were evaluated for this study. Inclusion criteria for total laparoscopic hysterectomy were: appropriate medical status for laparoscopic surgery; uterine size < 12 weeks of pregnancy; no previous longitudinal major abdominal surgery. Patients who had a pelvic organ prolapse greater than grade I, were excluded from this study.
Pre-operative work-up included gynecologic examination, trans-vaginal ultrasound. In case of early endometrial and cervical cancer a staging MRI or CT was performed.
Our institutional review board approved the study (Protocol number P/473/CE/2011), and all women gave their informed consent to use their data. All patients were adequately informed concerning the possible risks and benefits of the described technique and signed a written consent agreeing to undergo the procedure and to eventual conversion to LPS or laparotomy, if necessary.
Patients were randomly assigned to either a hysterectomy with LESS or with M-LPS. The surgeon was notified of the allocation in theater on the morning of the procedure. The same surgical team performed both techniques. Assignment to one of the two surgical approaches was on 1:1, using a block randomized computer-generated list.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •appropriate medical status for laparoscopic surgery;
- •uterine size < 12 weeks of pregnancy;
- •no previous longitudinal major abdominal surgery.
排除标准
- •pelvic organ prolapse greater than grade I
研究组 & 干预措施
micro-laparoscopy
M-LPS hysterectomy was performed through one optical trans-umbilical 5 mm trocar and three 3 mm sovra-pubic ancillary ports. A 5 mm 0° endoscope and 3 mm laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation and bipolar coagulator.
干预措施: micro-laparoscopy (Procedure)
laparoendoscopic single site surgery
LESS hysterectomy was performed through a multi-channel single trocar inserted in the umbilicus using an open technique (1.5-2 cm cutaneous incision), as previously reported. Intra-abdominal visualization was obtained with a 0° 5-mm telescope with a flexible tip.Working straight 5-mm instruments were inserted into the remaining 2 ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator and a multifunctional versatile laparoscopic device, which grasps, coagulates and transects simultaneously. In order to prevent clashing between instruments and surgeon's hands and to facilitate surgical manoeuvres, the combination of one 33 cm-long instrument with a 43 cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl.
干预措施: Laparoendoscopic single site surgery (Procedure)
结局指标
主要结局
Post-operative pain
时间窗: within 8 hours after surgery
次要结局
未报告次要终点
研究者
Prof. Giovanni Scambia
Clinical Professor
Catholic University of the Sacred Heart