Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

NCT02699489 | Completed Phase 3 DMC

• 1 other identifier: MEnROL
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Transplant Donor of Left Kidney

Outcome Measures

Primary Outcomes (1)

• Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),

  6 weeks

Secondary Outcomes (7)

• Short Form-36 (SF-36) health survey

  6 weeks

• Length of Hospital stay

  up to 2 weeks

• Ischemia times

  up to 1 day

• Duration of the procedure

  up to 24 hours

• Peri-operative complications

  90 days

Study Arms (2)

Laparoscopic donor nephrectomy arm

EXPERIMENTAL

This group will undergo laparoscopic donor nephrectomy

Procedure: Laparoscopic donor nephrectomy

Open donor nephrectomy arm

ACTIVE COMPARATOR

This group will undergo open donor nephrectomy

Procedure: Open donor nephrectomy

Interventions

Laparoscopic donor nephrectomy PROCEDURE

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

Laparoscopic donor nephrectomy arm

Open donor nephrectomy PROCEDURE

Open donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted

Open donor nephrectomy arm

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Urology, Urology and Nephrology Center

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: March 4, 2016
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share