NCT02699489

Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

Mansoura Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL): A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol

Detailed description

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.

Conditions

• Renal Transplant Donor of Left Kidney

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic donor nephrectomy	Laparoscopic donor nephrectomy performed via a standard 4-port distribution. Control of the hilar vessels is performed using extra-large Hem-o-Lok clips (Weck- Covidien, Research Triangle Park, NC) and graft extraction is performed via a pre-prepared Pfannenstiel incision
PROCEDURE	Open donor nephrectomy	Open donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-06-01
• Completion: 2015-11-01
• First posted: 2016-03-04
• Last updated: 2016-03-04