Hand-assisted laparoscopic donor nephrectomy of the right or left kidney

ISRCTN ISRCTN90285720
DOI https://doi.org/10.1186/ISRCTN90285720
Secondary identifying numbers N/A
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
07/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R.C. Minnee
Scientific

Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 566 4580
Email r.c.minnee@amc.uva.nl

Study information

Study designRandomized active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleHand-assisted laparoscopic donor nephrectomy of the right or left kidney
Study acronymLAPNIER
Study objectivesThe hypothesis was that donors who underwent a right sided Hand-Assisted Laparoscopic Donor Nephrectomy (HALDN) would have a shorter operation time.
Ethics approval(s)Approved 13/03/2002, Medical Ethical Commission, ref: MEC 02/225 # 02.17.1158
Health condition(s) or problem(s) studiedHand-Assisted Laparoscopic Donor Nephrectomy (HALDN)
InterventionSpecific 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 typeProcedure/Surgery
Primary outcome measureOperation time, measured during operation.
Secondary outcome measures1. 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 study start date15/04/2002
Completion date14/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Total final enrolment60
Key inclusion criteria1. Donors with age above 18 years
2. An identical kidney with regard to renal vascular anatomy
3. Renal function and urinary tract
4. Written informed consent
Key exclusion criteria1. Unilateral multiple renal arteries
Date of first enrolment15/04/2002
Date of final enrolment14/09/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results 27/07/2008 07/10/2021 No No

Editorial Notes

07/10/2021: Abstract and total final enrolment added.