MEnROL: Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20), [6 weeks]
Secondary Outcome Measures
- Short Form-36 (SF-36) health survey [6 weeks]
Scores of Short Form-36 questionnaire
- Length of Hospital stay [up to 2 weeks]
Length of hospital stay in days
- Ischemia times [up to 1 day]
Warm and Cold ischemia times in minutes
- Duration of the procedure [up to 24 hours]
Duration of the procedure in minutes
- Peri-operative complications [90 days]
Incidence of peri-operative complications in both groups
- One year graft loss [1 year]
Incidence of one year graft loss in both groups
- Recipient complications [90 days]
Incidence of recipient complications in both groups
Eligibility Criteria
Criteria
Inclusion Criteria:
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Donor aged 18 years or more.
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Donors who have the ability to understand information and materials provided.
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Donors who didn't express a preference for either open or laparoscopic surgery.
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Donors who are fit for both open and laparoscopic intervention
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Donors in whom evaluation revealed left kidney with single renal artery suitable for donation.
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Donors able to give signed written informed consent.
Exclusion Criteria:
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Donors who had a preference for either open or laparoscopic surgery.
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Donors in whom the right kidney was chosen for donation.
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Donors with double renal arteries in kidneys chosen for donation.
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Donors who didn't sign consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEnROL