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Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL)

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ClinicalTrials.gov Identifier: NCT02699489
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
ahmed mansour, 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

Condition or disease Intervention/treatment Phase
Renal Transplant Donor of Left Kidney Procedure: Laparoscopic donor nephrectomy Procedure: Open donor nephrectomy Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mansoura Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL): A Randomized Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Laparoscopic donor nephrectomy arm
This group will undergo laparoscopic donor nephrectomy
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

Active Comparator: Open donor nephrectomy arm
This group will undergo open donor nephrectomy
Procedure: Open donor nephrectomy
Open donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted




Primary Outcome Measures :
  1. Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20), [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Short Form-36 (SF-36) health survey [ Time Frame: 6 weeks ]
    Scores of Short Form-36 questionnaire

  2. Length of Hospital stay [ Time Frame: up to 2 weeks ]
    Length of hospital stay in days

  3. Ischemia times [ Time Frame: up to 1 day ]
    Warm and Cold ischemia times in minutes

  4. Duration of the procedure [ Time Frame: up to 24 hours ]
    Duration of the procedure in minutes

  5. Peri-operative complications [ Time Frame: 90 days ]
    Incidence of peri-operative complications in both groups

  6. One year graft loss [ Time Frame: 1 year ]
    Incidence of one year graft loss in both groups

  7. Recipient complications [ Time Frame: 90 days ]
    Incidence of recipient complications in both groups



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: ahmed mansour, Lecturer in Urology, Urology and Nephrology Center, Mansoura University
ClinicalTrials.gov Identifier: NCT02699489     History of Changes
Other Study ID Numbers: MEnROL
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data are readily shared with requesting authorities