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Right-sided Hand-Assisted RetroPeritoneoscopic versus standard laparoscopic donor nephrectomy.


- candidate number10426
- NTR NumberNTR3096
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-okt-2011
- Secondary IDs2010-168 METC Erasmus MC
- Public TitleRight-sided Hand-Assisted RetroPeritoneoscopic versus standard laparoscopic donor nephrectomy.
- Scientific TitleRight-sided Hand-Assisted RetroPeritoneoscopic versus standard laparoscopic donor nephrectomy.
- ACRONYMHARP-II
- hypothesisTo determine the best approach for right-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) studiedDonor nephrectomy, Live kidney donors
- Inclusion criteria1. Potential participants are those willing and approved to donate a kidney by life;
2. Participants must be able to donate the right kidney, not have undergone kidney or adrenal gland surgery on the right side and understand English sufficiently to fill out the questionnaires.
- Exclusion criteriaParticipants must not have undergone kidney or adrenal gland surgery on the left side and understand English sufficiently to fill out the questionnaires.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate29-feb-2012
- Target number of participants40
- InterventionsThis trial randomizes donors for either laparoscopic or hand-assisted retroperitoneoscopic (HARP) donor nephrectomy to assess the role of HARP for kidney donation.
- Primary outcomeSurgery time.
- Secondary outcome1. Quality of life (SF-36, EQ-5D);
2. Costefficacy from a healthcare and societal perspective;
3. Intra- and postoperative complications;
4. Postoperative pain-recovery;
5. Hospital stay and resumption of work;
6. Kidney function of donor and recipient;
7. Transplantfunction of the recipient.
- TimepointsFollow-up will be one year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES K.W.J. Klop
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.N.M. IJzermans
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Mrace Comittee, Erasmus MC, Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryTransplantation 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. 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 right-sided donor nephrectomy.
- Main changes (audit trail)
- RECORD10-okt-2011 - 18-okt-2011


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