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

NCT01236326 | Completed Results

• 1 other identifier: 1009011249
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Living Donors; Nephrectomy; Kidney Transplantation; Surgery, Laparoscopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

LESS-DN

ACTIVE COMPARATOR

Procedure: Laparoendoscopic single site donor nephrectomy

Conventional LDN

ACTIVE COMPARATOR

Procedure: Conventional laparoscopic donor nephrectomy

Interventions

Laparoendoscopic single site donor nephrectomy PROCEDURE

Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy

LESS-DN

Conventional laparoscopic donor nephrectomy PROCEDURE

Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Conventional LDN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Limitations and Caveats

Inability to secure complete data on the donor questionnaires (25% of subjects did not return 2-month questionnaire); no validated tool available to assess donor recovery and satisfaction; clinical donor follow-up was suboptimal.

Results Point of Contact

• Title: Meredith J. Aull, Pharm.D.
• Organization: Weill Cornell Medical College

mea9008@med.cornell.edu

(212) 746-0727

Study Officials

• Joseph J Del Pizzo, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 12, 2019
• Results First Posted: August 26, 2015

Record last verified: 2019-05

Locations

US (1)