To determine the best approach for left-sided live donor nephrectomy to optimise donor’s safety and comfort while reducing donation related costs, with equal or better quality of life for the HARP-technique.
ID
Bron
Verkorte titel
Aandoening
live kidney donors, surgical technique
nierdonatie bij leven, chirurgische techniek
Ondersteuning
- Fonds Nuts-Ohra
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary study parameters/outcome of the study: <br>
- 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.
Achtergrond van het onderzoek
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 patient’s mortality and decrease the transplantation waiting list.
Implementation of live donation offers the possibility to transplant before the kidney disease reaches it’s 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 donor’s 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.
Doel van het onderzoek
To determine the best approach for left-sided live donor nephrectomy to optimise donor’s safety and comfort while reducing donation related costs, with equal or better quality of life for the HARP-technique.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
This trial randomizes donors for either laparoscopic or hand-assisted retroperitoneoscopic (HARP) donor nephrectomy to assess the role of HARP for kidney donation.
Publiek
L.F.C. Dols
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7032848
l.dols@erasmusmc.nl
Wetenschappelijk
L.F.C. Dols
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7032848
l.dols@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Participants must not have undergone kidney or adrenal gland surgery on the left side and understand English sufficiently to fill out the questionnaires.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1371 |
NTR-old | NTR1433 |
Ander register | : MEC-2007-198 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |