|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR3096 |
|
Date of registration:
|
10/10/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Right-sided Hand-Assisted RetroPeritoneoscopic versus standard laparoscopic donor nephrectomy.
|
|
Scientific title:
|
Right-sided Hand-Assisted RetroPeritoneoscopic versus standard laparoscopic donor nephrectomy. - HARP-II |
|
Date of first enrolment:
|
1/4/2011 |
|
Target sample size:
|
40 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3096 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
J.N.M.
IJzermans |
|
Address:
|
Erasmus University Medical Center
PO Box 2040
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
+31 (0)10 7033727 |
|
Email:
|
j.ijzermans@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
K.W.J.
Klop |
|
Address:
|
Postbus 2040, Erasmus MC, kamer Z-838
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
|
|
Email:
|
k.klop@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. 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 criteria: Participants must not have undergone kidney or adrenal gland surgery on the left side and understand English sufficiently to fill out the questionnaires.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Donor nephrectomy, Live kidney donors
|
|
Intervention(s)
|
|
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(s)
|
|
Surgery time.
|
|
Secondary Outcome(s)
|
1. 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.
|
|
Source(s) of Monetary Support
|
|
Mrace Comittee, Erasmus MC, Fonds Nuts-Ohra
|
|