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

Not Applicable

Completed

• Conditions: Nephrectomy; Surgery, Laparoscopic; Living Donors; Kidney Transplantation
• Interventions: Procedure: Conventional laparoscopic donor nephrectomy; Procedure: Laparoendoscopic single site donor nephrectomy

• Registration Number: NCT01236326
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Primary Completion: 2013-06
• Study Completion: 2013-10
• Results First Submitted: 2015-07-29
• Results First Submitted QC: 2015-07-29
• Results First Posted: 2015-08-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.

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Exclusion Criteria

• There are no exclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional LDN	Conventional laparoscopic donor nephrectomy	-
LESS-DN	Laparoendoscopic single site donor nephrectomy	-

Primary Outcome Measures

Name	Time	Method
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.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NewYork-Presbyterian Hospital/Weill Cornell Medical Center; 🇺🇸 New York, New York, United States