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
Scientific
Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 4580 |
|---|---|
| r.c.minnee@amc.uva.nl |
Study information
| Study design | Randomized active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 15/04/2002 |
| Completion date | 14/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
