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

Study Overview
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Brief Summary
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Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due to the many advantages it offers over open nephrectomy, including significantly shorter hospitalization and recovery time, and significantly improved cosmetic result related to the nephrectomy scar(s). More recently, a new procedure has been introduced to the field of laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as the single incision site through which the entire donor nephrectomy is performed. The LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay, lessening recovery time, and improving satisfaction with the surgical scar. The investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in living kidney donors. The investigators will compare operative times and intra-operative donor management, intra- and post-operative complications, pain scores, analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and function and survival of the transplanted kidney for the two groups of subjects: (1) the group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the laparoendoscopic single site donor nephrectomy.

Official Title
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A Randomized, Prospective, Parallel Group Study of Conventional Laparoscopic Donor Nephrectomy (LDN) Versus Laparoendoscopic Single Site Donor Nephrectomy (LESS-DN) in Living Donor Kidney Transplantation

Conditions
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Living Donors, Nephrectomy, Kidney Transplantation, Surgery, Laparoscopic

Intervention / Treatment
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* Procedure: Laparoendoscopic single site donor nephrectomy
* Procedure: Conventional laparoscopic donor nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study. Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: LESS-DN<br> | Procedure: Laparoendoscopic single site donor nephrectomy<br>* Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy<br>|
| Active Comparator: Conventional LDN<br> | Procedure: Conventional laparoscopic donor nephrectomy<br>* Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity. | The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days on Oral Pain Medication After Discharge |  | 2 months | 
| Days Before Going Back to Work |  | 2 months | 
| Days to Normal Day-to-day Activities |  | 2 months | 
| Recovered by 2 Months After Donation |  | 2 months |