Mansoura Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL): A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),
研究概览
简要总结
A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol
详细描述
The MEnROL trial is a phase III randomized controlled trial of Open versus Laparoscopic donor nephrectomy within a standardized enhanced recovery program. Eligible donors were randomized in a 1:1 ratio.
Laparoscopic procedures are performed by a single surgeon (AMM) while Open donor nephrectomies (ODN) were performed by an experienced team that included the laparoscopic surgeon. ODN were performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted. Laparoscopic donor nephrectomy (LDN) was performed via a standard 4-port distribution. Control of the hilar vessels was performed using extra-large Hem-o-Lok clips (Weck- Covidien, Research Triangle Park, NC) and graft extraction was performed via a pre-prepared Pfannenstiel incision.
Donors are enrolled in our enhanced recovery program for donor nephrectomy. The program was compliant with the Enhanced Recovery After Surgery Group (ERAS) guidelines. All donors receive epidural analgesia and are maintained on non-narcotic postoperative analgesics. Criteria for hospital discharge include ambulation, adequate pain control with oral analgesics, and sustained intake of solid food.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Donor aged 18 years or more.
- •Donors who have the ability to understand information and materials provided.
- •Donors who didn't express a preference for either open or laparoscopic surgery.
- •Donors who are fit for both open and laparoscopic intervention
- •Donors in whom evaluation revealed left kidney with single renal artery suitable for donation.
- •Donors able to give signed written informed consent.
排除标准
- •Donors who had a preference for either open or laparoscopic surgery.
- •Donors in whom the right kidney was chosen for donation.
- •Donors with double renal arteries in kidneys chosen for donation.
- •Donors who didn't sign consent.
结局指标
主要结局
Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),
时间窗: 6 weeks
次要结局
- Length of Hospital stay(up to 2 weeks)
- Duration of the procedure(up to 24 hours)
- Peri-operative complications(90 days)
- Recipient complications(90 days)
- Ischemia times(up to 1 day)
- One year graft loss(1 year)
- Short Form-36 (SF-36) health survey(6 weeks)
研究者
ahmed mansour
Lecturer in Urology, Urology and Nephrology Center
Mansoura University