Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

Renal Transplant Donor of Left Kidney Clinical Trial

— MEnROL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699489
• Other study ID #: MEnROL
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2016
• Last updated: February 29, 2016
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant Donor of Left Kidney

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),		6 weeks	No
Secondary	Short Form-36 (SF-36) health survey	Scores of Short Form-36 questionnaire	6 weeks	No
Secondary	Length of Hospital stay	Length of hospital stay in days	up to 2 weeks	No
Secondary	Ischemia times	Warm and Cold ischemia times in minutes	up to 1 day	No
Secondary	Duration of the procedure	Duration of the procedure in minutes	up to 24 hours	No
Secondary	Peri-operative complications	Incidence of peri-operative complications in both groups	90 days	No
Secondary	One year graft loss	Incidence of one year graft loss in both groups	1 year	No
Secondary	Recipient complications	Incidence of recipient complications in both groups	90 days	No