Renal Transplant Donor of Left KidneyPhase 3MEnROLNCT02699489
Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy
A Phase 3 study testing Laparoscopic donor nephrectomy and Open donor nephrectomy in people with Renal Transplant Donor of Left Kidney, run by Mansoura University.
Trial summary
A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplant Donor of Left Kidney
- What is being tested?
- Laparoscopic donor nephrectomy and Open donor nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Mansoura Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL): A Randomized Controlled Trial
A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol
Read the 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.
- Conditions
- Renal Transplant Donor of Left Kidney
- Being tested
- Laparoscopic donor nephrectomy, Open donor nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic donor nephrectomyProcedure or surgery
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 nephrectomyProcedure or surgery
Open donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic donor nephrectomy arm | Experimental | This group will undergo laparoscopic donor nephrectomy Receives: Procedure: Laparoscopic donor nephrectomy |
| Open donor nephrectomy arm | Active comparator | This group will undergo open donor nephrectomy Receives: Procedure: Open donor nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),
Measured: 6 weeks
Secondary outcomes (7)
Short Form-36 (SF-36) health survey
Scores of Short Form-36 questionnaire
Measured: 6 weeks
Length of Hospital stay
Length of hospital stay in days
Measured: up to 2 weeks
Ischemia times
Warm and Cold ischemia times in minutes
Measured: up to 1 day
Duration of the procedure
Duration of the procedure in minutes
Measured: up to 24 hours
Peri-operative complications
Incidence of peri-operative complications in both groups
Measured: 90 days
One year graft loss
Incidence of one year graft loss in both groups
Measured: 1 year
Recipient complications
Incidence of recipient complications in both groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Donor of Left KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699489
- Sponsor's protocol ID
- MEnROL
- Acronym
- MEnROL
- Status last verified
- Feb 2016
- First submitted
- 13 Jan 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data are readily shared with requesting authorities
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mansoura Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy (MEnROL): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02699489
- Acronym / sponsor ID
- MEnROL / MEnROL
- Conditions
- Renal Transplant Donor of Left Kidney
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic donor nephrectomy arm | Experimental | Procedure: Laparoscopic donor nephrectomyThis group will undergo laparoscopic donor nephrectomy |
| Open donor nephrectomy arm | Active comparator | Procedure: Open donor nephrectomyThis group will undergo open donor nephrectomy |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic donor nephrectomyLaparoscopic 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 | Procedure or surgery | Laparoscopic donor nephrectomy arm |
| Open donor nephrectomyOpen donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted | Procedure or surgery | Open donor nephrectomy arm |
Primary outcome
Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),
Time frame: 6 weeks
7 secondary outcomes
Short Form-36 (SF-36) health survey
Time frame: 6 weeks
Length of Hospital stay
Time frame: up to 2 weeks
Ischemia times
Time frame: up to 1 day
Duration of the procedure
Time frame: up to 24 hours
Peri-operative complications
Time frame: 90 days
One year graft loss
Time frame: 1 year
Recipient complications
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Individual participant dataSharing planned: Yes. Individual participant data are readily shared with requesting authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic donor nephrectomy and Open donor nephrectomy in people with Renal Transplant Donor of Left Kidney, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20), (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.