Transplant Trial Watch

A randomized clinical trial of living donor nephrectomy: a plea for a differentiated appraisal of mini-open muscle splitting incision and hand-assisted laparoscopic donor nephrectomy.

Hofker HS, Nijboer WN, et al.

Transplant International 2012; 25(9):976-86.


Aims
To compare mini-open muscle splitting incision (MSI) versus hand-assisted laparoscopic (HAL) in living donor nephrectomy using a non-inferiority design.

Interventions
MSI versus HAL in living donor nephrectomy.

Participants
50 adult living kidney donors

Outcomes
The primary outcome was postoperative pain scored both in rest and during provocation by coughing using the visual analogue scale. Secondary outcomes included serum C-reactive protein (CRP), interleukin 6 (IL-6) as acute phase proteins, intra-operative variables (operating time, decrease in hemoglobin), peri-operative complications, quality of life, total morphine use, postoperative use of oral analgesics in the outpatient setting, time to return to work, and renal function in the donor (at 8 weeks) and recipient (at 3 months).

Follow-up
1 year

CET Conclusions
This small well designed trial in 50 living kidney donors suggests that there was less pain after mini-open muscle splitting incision (MSI) nephrectomy compared to hand assisted laparoscopic nephrectomy. There was less pain after surgery and also a reduced morphine requirement with the MSI technique and reduced inflammatory cytokine levels. However it should be noted that operative time for both techniques was considerable, around 4 hours for each technique, but in particular there were several complications in the MSI group that would give rise to concern. These were a DVT and pulmonary embolus in one patient, and a need for post operative blood transfusion in another patient as well as a renal artery thrombosis and a ureteric stenosis requiring reoperation. Thus although the authors claim that there is a case for saying that the MSI technique is superior to the HAL technique, I think that is a little premature based on this study.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
Yes

Trial registration
Clinicaltrials.gov - NCT00258986

Funding source
Non-industry funded