N/A
N=105
Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation
Living Donors · Nephrectomy · Kidney Transplantation · Surgery, Laparoscopic
Bottom Line
View on ClinicalTrials.gov: NCT01236326 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: 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. — 43; 45 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laparoendoscopic single site donor nephrectomy (Procedure); Conventional laparoscopic donor nephrectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
43; 45 | — |
| SECONDARY Days on Oral Pain Medication After Discharge |
6; 7 | — |
| SECONDARY Days Before Going Back to Work |
24; 27 | — |
| SECONDARY Days to Normal Day-to-day Activities |
30; 33 | — |
| SECONDARY Recovered by 2 Months After Donation |
35; 31 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.
Exclusion Criteria
- There are no exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01236326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.