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临床试验/NCT01048931
NCT01048931Unknown3 期

To Compare to Single-port Access Laparoscopic-assisted Vaginal Hysterectomy (LAVH) and Multiple Ports LAVH: A Randomized Controlled Trial

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
3 期
入组人数
100
试验地点
2
主要终点
To assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The pain score and morbidity associated with surgery will be noted.

研究概览

简要总结

Minimally invasive surgery has become the standard treatment for many gynecologic disease processes. In the last decade, numerous studies have demonstrated that laparoscopic approaches to various gynecologic oncology conditions-particularly for early-stage endometrial and cervical cancers as well as select pelvic masses-is feasible and results in shorter hospital stays, improved quality of life and comparable surgical and oncologic outcomes to abdominal staging [1-5].For instance, the typical gynecologic robotic surgical procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an even less invasive alternative to conventional laparoscopy surgery has been developed: laparoendoscopic single-site surgery (LESS), also known as single-port surgery. 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. However, to our knowledge, there are no randomize control trial to evaluate of single port or multiple ports laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of SPA-LAVH in the treatment of benign uterine disease.

详细描述

Overall Study Design:

Participants:

This clinical controlled trial will be undertaken among patients who will receive laparoscopic-assisted vaginal hysterectomy.

Interventions:

All the patients will receive laparoscopic surgery using CO2 gas as distension medium. At the end of the surgery, in the control group, CO2 was removed by passive exsufflation through the port site. The patients will be placed in the Trendelenburg position (30 degrees).

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
30 Years 至 70 Years(Adult, Older Adult)
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.

结局指标

主要结局

To assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The pain score and morbidity associated with surgery will be noted.

时间窗: 1 year

次要结局

  • To evaluate the cosmetic outcome.(1 year)

研究者

申办方类型
Other Gov

研究点 (2)

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