Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

Phase 3

Completed

• Conditions: Renal Transplant Donor of Left Kidney
• Interventions: Procedure: Open donor nephrectomy; Procedure: Laparoscopic donor nephrectomy

• Registration Number: NCT02699489
• Lead Sponsor: Mansoura University

Brief 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-06
• Study Completion: 2015-11
• Study First Submitted: 2016-01-13
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open donor nephrectomy arm	Open donor nephrectomy	This group will undergo open donor nephrectomy
Laparoscopic donor nephrectomy arm	Laparoscopic donor nephrectomy	This group will undergo laparoscopic donor nephrectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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