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临床试验/NCT01564602
NCT01564602Unknown不适用

Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年1月最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

vghtpe user

Director

Taipei Veterans General Hospital, Taiwan

研究点 (2)

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