Clinical trial NCT02699489: Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy
Official title: Mansoura Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant Donor of Left Kidney
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 224
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),
timeFrame: 6 weeks
Secondary outcomes:
measure: Short Form-36 (SF-36) health survey
timeFrame: 6 weeks
measure: Length of Hospital stay
timeFrame: up to 2 weeks
measure: Ischemia times
timeFrame: up to 1 day
measure: Duration of the procedure
timeFrame: up to 24 hours
measure: Peri-operative complications
timeFrame: 90 days
measure: One year graft loss
timeFrame: 1 year
measure: Recipient complications
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: