Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

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

Detailed Description
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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.

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

Conditions
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Renal Transplant Donor of Left Kidney

Intervention / Treatment
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* Procedure: Laparoscopic donor nephrectomy
* Procedure: Open donor nephrectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic donor nephrectomy arm<br>This group will undergo laparoscopic donor nephrectomy | Procedure: Laparoscopic donor nephrectomy<br>* 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<br>|
| Active Comparator: Open donor nephrectomy arm<br>This group will undergo open donor nephrectomy | Procedure: Open donor nephrectomy<br>* Open donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20), |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-36 (SF-36) health survey | Scores of Short Form-36 questionnaire | 6 weeks | 
| Length of Hospital stay | Length of hospital stay in days | up to 2 weeks | 
| Ischemia times | Warm and Cold ischemia times in minutes | up to 1 day | 
| Duration of the procedure | Duration of the procedure in minutes | up to 24 hours | 
| Peri-operative complications | Incidence of peri-operative complications in both groups | 90 days | 
| One year graft loss | Incidence of one year graft loss in both groups | 1 year | 
| Recipient complications | Incidence of recipient complications in both groups | 90 days |