Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The operative time
研究概览
简要总结
The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.
详细描述
Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate that the techniques are feasible provided that both optimal surgical technical expertise with advanced skills and optimal instrumentation are available. Recently, Lee et al. performed the multiple channel single port-access laparoscopic-assisted vaginal hysterectomy (SPA-LAVH) in 24 patient. All cases but 3 were performed exclusively through a single port. The median operative time, weight of the uterus, and estimated blood loss were 119 minutes (range 90 to 255 minutes), 347 g (range 225 to 732 g), and 400 mL (range 100 to 1000 mL), respectively. The median hospital stay (postoperative day) was 3 days (range 3 to 7). Although there are a limited number of studies demonstrating the feasibility of single-port access laparoscopic-assisted vaginal hysterectomy (LAVH), single-port surgery is "new-old" (i.e., a revisited and unstandardized technique) because the major disadvantage of limited movement caused by collisions of the laparoscopic instruments has been mitigated by the development of multi-channel approaches. Therefore, the investigators used a 2-channel single-port system, which was different from the previously published 3-channel single-port technique11,12 to reduce collisions and aid the assistant in controlling the scope without interfering with the surgeon's instruments. To our knowledge, there are no randomize control trial to evaluate of 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of 2-channel and multiple-channel single port laparoscopy in the treatment of benign uterine disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
- •American Society of Anesthesiologists (ASA) physical status of patient: classification I-II
排除标准
- •The procedure will be required to conversion to laparotomy.
- •Any cardio-vascular diseases.
- •Malignant disease
研究组 & 干预措施
single port laparoscopic surgery
2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders
干预措施: comparison multiple channel port laparoscopic surgery (Device)
结局指标
主要结局
The operative time
时间窗: We will follow the patients until one month after the surgery.
We will follow the patients until one month after the surgery. The primary outcome measure of this trial is the effect and safety of single port-access laparoscopic-assisted vaginal hysterectomy.
次要结局
- blood loss(one month)
- weight of the uterus(one month)
- hospital length of stay(one month)
- morbidity(one month)
研究者
vghtpe user
Director
Taipei Veterans General Hospital, Taiwan
