Contact information
Type
Scientific
Primary contact
Dr R.C. Minnee
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 4580
r.c.minnee@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LAPNIER STUDY
Study hypothesis
The hypothesis was that donors who underwent a right sided Hand-Assisted Laparoscopic Donor Nephrectomy (HALDN) would have a shorter operation time.
Ethics approval
Ethics approval received from the Medical Ethical Commission on the 13th March 2002 (ref: MEC 02/225 # 02.17.1158).
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hand-Assisted Laparoscopic Donor Nephrectomy (HALDN)
Intervention
Specific preoperative donor evaluation included blood and urine examination, angiography, pyelography and renal scintigraphy. In case of bilateral multiple arteries they were only included in the study if both kidneys were judged transplantable by the surgeon. The hand-assisted laparoscopic donor nephrectomy (HALDN) is done transperitoneally.
After open dissection of the distal ureter and gonadal vein through a 7 - 8 cm Pfannenstiel incision the non dominant operators' hand is introduced through a handport and two 10 - 12 mm trocars are placed. The insufflation pressure was maximally 12 mmHg. The right or left colon was then mobilised. After transecting the ureter distally, the renal artery is transected with metal clips, while an endoscopic stapler is used to transect the renal vein. The kidney is extracted through the Pfannenstiel incision and cold flushed and preserved with University of Wisconsin solution (UW).
Postoperatively, all patients are treated equally with regard to feeding, pain regulation, mobilisation and postoperative care.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Operation time, measured during operation.
Secondary outcome measures
1. Donor morbidity, measurements were prospectively collected
2. Warm ischaemia time, measured during operation
3. Delayed graft function, measurements were prospectively collected
4. Urological complications, measurements were prospectively collected
5. Graft survival, measurements were prospectively collected until one year after transplantation when most patients went to peripheral centers
6. Quality of life, measured using the following questionnaires:
6.1. 36-item Short Form Health Survey (SF-36): donors received these forms preoperatively and at 1, 2, 4, weeks, 3, 6 and 12 months
6.2. Gastro-Intestinal Quality of Life index (GIQLI): donors received these forms preoperatively and at 1, 2, 4, weeks, 3, 6 and 12 months
6.3. Multidimensional Fatigue Inventory-20 (MFI-20) was administered preoperatively and at 1, 3, 6 and 12 months
6.4. Visual analogue scale (VAS) was measured preoperatively and at day 1, 2, 3, 7 and 28
Overall trial start date
15/04/2002
Overall trial end date
14/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Donors with age above eighteen years
2. An identical kidney with regard to renal vascular anatomy
3. Renal function and urinary tract
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Unilateral multiple renal arteries
Recruitment start date
15/04/2002
Recruitment end date
14/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary