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临床试验/NCT01236326
NCT01236326已完成不适用

A Randomized, Prospective, Parallel Group Study of Conventional Laparoscopic Donor Nephrectomy (LDN) Versus Laparoendoscopic Single Site Donor Nephrectomy (LESS-DN) in Living Donor Kidney Transplantation

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2010年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.

研究概览

简要总结

Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due to the many advantages it offers over open nephrectomy, including significantly shorter hospitalization and recovery time, and significantly improved cosmetic result related to the nephrectomy scar(s). More recently, a new procedure has been introduced to the field of laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as the single incision site through which the entire donor nephrectomy is performed. The LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay, lessening recovery time, and improving satisfaction with the surgical scar. The investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in living kidney donors. The investigators will compare operative times and intra-operative donor management, intra- and post-operative complications, pain scores, analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and function and survival of the transplanted kidney for the two groups of subjects: (1) the group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the laparoendoscopic single site donor nephrectomy.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.

排除标准

  • •There are no exclusion criteria.

研究组 & 干预措施

LESS-DN

Active Comparator

干预措施: Laparoendoscopic single site donor nephrectomy (Procedure)

Conventional LDN

Active Comparator

干预措施: Conventional laparoscopic donor nephrectomy (Procedure)

结局指标

主要结局

The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.

时间窗: 1 year

The Primary Endpoint of the Study Will be Patient Self-reported "Return to 100%", as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity.

次要结局

  • Days on Oral Pain Medication After Discharge(2 months)
  • Days Before Going Back to Work(2 months)
  • Days to Normal Day-to-day Activities(2 months)
  • Recovered by 2 Months After Donation(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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