Condition category
Surgery
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
28/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes