Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL)

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

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

Study Overview

• Status: Completed
• Conditions: Renal Transplant Donor of Left Kidney
• Intervention / Treatment: Procedure: Laparoscopic donor nephrectomy; Procedure: Open donor nephrectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Donor aged 18 years or more.
2. Donors who have the ability to understand information and materials provided.
3. Donors who didn't express a preference for either open or laparoscopic surgery.
4. Donors who are fit for both open and laparoscopic intervention
5. Donors in whom evaluation revealed left kidney with single renal artery suitable for donation.
6. Donors able to give signed written informed consent.

Exclusion Criteria:

1. Donors who had a preference for either open or laparoscopic surgery.
2. Donors in whom the right kidney was chosen for donation.
3. Donors with double renal arteries in kidneys chosen for donation.
4. Donors who didn't sign consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic donor nephrectomy arm; This group will undergo laparoscopic donor nephrectomy	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
Active Comparator: Open donor nephrectomy arm; This group will undergo open donor nephrectomy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36 (SF-36) health survey	Scores of Short Form-36 questionnaire	6 weeks
Length of Hospital stay	Length of hospital stay in days	up to 2 weeks
Ischemia times	Warm and Cold ischemia times in minutes	up to 1 day
Duration of the procedure	Duration of the procedure in minutes	up to 24 hours
Peri-operative complications	Incidence of peri-operative complications in both groups	90 days
One year graft loss	Incidence of one year graft loss in both groups	1 year
Recipient complications	Incidence of recipient complications in both groups	90 days

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MEnROL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data are readily shared with requesting authorities