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OpenTrials
Completed

NCT Number: NCT02699489

Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

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

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: MEnROL

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2016
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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