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

ISRCTN	ISRCTN90285720
DOI	https://doi.org/10.1186/ISRCTN90285720
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

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

Primary study design	Interventional
Study design	Randomized active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title	Hand-assisted laparoscopic donor nephrectomy of the right or left kidney
Study acronym	LAPNIER
Study objectives	The 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) studied	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
Primary outcome measure(s)	Operation time, measured during operation.
Key secondary outcome measure(s)	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
Completion date	14/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key inclusion criteria	1. 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 criteria	1. Unilateral multiple renal arteries
Date of first enrolment	15/04/2002
Date of final enrolment	14/09/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.