|- candidate number||3926|
|- NTR Number||NTR1433|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-sep-2008|
|- Secondary IDs||MEC-2007-198 |
|- Public Title||Hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy|
|- Scientific Title||Hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy|
|- hypothesis||To determine the best approach for left-sided live donor nephrectomy to optimise donorís safety and comfort while reducing donation related costs, with equal or better quality of life for the HARP-technique.|
|- Healt Condition(s) or Problem(s) studied||Donor nephrectomy, Live kidney donors|
|- Inclusion criteria||1. Potential participants are those willing and approved to donate a kidney by life. |
2. Participants must be able to donate the left kidney, not have undergone kidney or adrenal gland surgery on the left side and understand English sufficiently to fill out the questionnaires.
|- Exclusion criteria||1. Participants must not have undergone kidney or adrenal gland surgery on the left side and understand English sufficiently to fill out the questionnaires. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-jul-2008|
|- planned closingdate||24-jul-2010|
|- Target number of participants||190|
|- Interventions||This trial randomizes donors for either laparoscopic or hand-assisted retroperitoneoscopic (HARP) donor nephrectomy to assess the role of HARP for kidney donation. |
|- Primary outcome||Primary study parameters/outcome of the study: |
- Physical function, which is a dimension of quality of life. This is measured with the SF-36 questionnaire and includes items like walking stairs and carrying groceries.
|- Secondary outcome||Secondary study parameters/outcome of the study: |
- Costefficacy from a healthcare and societal perspective
- Intra- and postoperative complications
- Other quality of life dimensions
- Postoperative pain-recovery
- Hospital stay and resumption of work
- Kidney function of donor and recipient
- Transplantfunction of the recipient.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L.F.C. Dols|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.N.M. IJzermans|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Mrace Comittee, Erasmus MC, Fonds Nuts-Ohra|
|- Brief summary||Transplantation is the only treatment offering long-term benefit to patients with chronic kidney failure. As the number of patients suffering end stage renal disease increases, the recruitment of more kidney donors is important. Live kidney donation is the most realistic option to reduce donor shortage. Increasing the number of donors may reduce patientís mortality and decrease the transplantation waiting list. |
Implementation of live donation offers the possibility to transplant before the kidney disease reaches itís terminal phase necessitating dialysis. Thus, this so called pre-emptive transplantation may prevent unnecessary surgical intervention to establish dialysis (including costs and mortality). To date the number of non-related live kidney donations is rising.
Living kidney donor nephrectomy is performed on healthy individuals who receive no direct therapeutic benefit of the procedure themselves. In order to guarantee donorís safety, it is important to optimise the surgical approach. Recently we demonstrated the benefit of laparoscopic nephrectomy to the donor. However, this method is characterized by high costs, long operation times and requires a well-trained surgeon. Especially on the left side we experience more intra-operative complications. An alternative to the fully laparoscopic approach may be the hand-assisted retroperitoneoscopic technique.
The peritoneum remains intact and the risk of visceral injuries is reduced. Due to the hand-assistance the procedure is fast and the time on the operation table may be reduced significantly. The feasibility of this method has been demonstrated recently , but as to date there are no data available advocating the use of one technique above the other. This randomised controlled trial compares the hand-assisted retroperitoneal approach to the current standard, the transabdominal laparoscopic technique, to define the most optimal approach for left-sided donor nephrectomy.
|- Main changes (audit trail)|
|- RECORD||5-sep-2008 - 16-sep-2008|