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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236326
• Other study ID #: 1009011249
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: October 2013

Study information

• Verified date: May 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• There are no exclusion criteria.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Laparoendoscopic single site donor nephrectomy
Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
• Conventional laparoscopic donor nephrectomy
Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days on Oral Pain Medication After Discharge		2 months
Secondary	Days Before Going Back to Work		2 months
Secondary	Days to Normal Day-to-day Activities		2 months
Secondary	Recovered by 2 Months After Donation		2 months