Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study Comparing Hand-assisted Laparoscopic and Mini-incision Muscle Splitting Incision Living Donor Nephrectomy

NCT00258986

Living Donors

COMPLETED PHASE3

Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy

NCT00460889

Living Renal Donor

WITHDRAWN

Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation

NCT01236326

Living Donors Nephrectomy Kidney Transplantation +1 more

COMPLETED NA

Retroperitoneoscopic Donor Nephrectomy

NCT03893656

Transplant; Complication, Failure

COMPLETED

Outcome of Renal Transplant on a Defunctionalized Bladder

NCT02665572

Renal Transplantation Into a Defunctionalized Bladder

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplant Donor of Left Kidney

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic donor nephrectomy arm

This group will undergo laparoscopic donor nephrectomy

Group Type EXPERIMENTAL

Laparoscopic donor nephrectomy

Intervention Type 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 arm

This group will undergo open donor nephrectomy

Group Type ACTIVE_COMPARATOR

Open donor nephrectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes