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OpenTrials
Completed

NCT Number: NCT01236326

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • There are no exclusion criteria.

Treatment and study plan

Laparoendoscopic single site donor nephrectomy

Procedure

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

Conventional laparoscopic donor nephrectomy

Procedure

Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

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.

    Time frame: 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 outcomes

  1. Days on Oral Pain Medication After Discharge

    Time frame: 2 months

  2. Days Before Going Back to Work

    Time frame: 2 months

  3. Days to Normal Day-to-day Activities

    Time frame: 2 months

  4. Recovered by 2 Months After Donation

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2010
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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