Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

Mansoura University224 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Renal Transplant Donor of Left Kidney

Interventions

Laparoscopic donor nephrectomyPROCEDURE

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 nephrectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

Short Form-36 (SF-36) health survey

Scores of Short Form-36 questionnaire

Time frame: 6 weeks

Length of Hospital stay

Length of hospital stay in days

Time frame: up to 2 weeks

Ischemia times

Warm and Cold ischemia times in minutes

Time frame: up to 1 day

Duration of the procedure

Duration of the procedure in minutes

Time frame: up to 24 hours

Peri-operative complications

Incidence of peri-operative complications in both groups

Time frame: 90 days

One year graft loss

Incidence of one year graft loss in both groups

Time frame: 1 year

Recipient complications

Incidence of recipient complications in both groups

Time frame: 90 days

Data from ClinicalTrials.gov

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