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

NCT ID: NCT01236326

Last Updated: 2019-06-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-10-31

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.

Detailed Description

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Conditions

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Living Donors Nephrectomy Kidney Transplantation Surgery, Laparoscopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LESS-DN

Group Type ACTIVE_COMPARATOR

Laparoendoscopic single site donor nephrectomy

Intervention Type PROCEDURE

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

Conventional LDN

Group Type ACTIVE_COMPARATOR

Conventional laparoscopic donor nephrectomy

Intervention Type PROCEDURE

Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Interventions

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Laparoendoscopic single site donor nephrectomy

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

Intervention Type PROCEDURE

Conventional laparoscopic donor nephrectomy

Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph J Del Pizzo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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NewYork-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1009011249

Identifier Type: -

Identifier Source: org_study_id

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