Transplant Trial Watch

Bipolar vessel sealing system versus silk ligation of lymphatic vessels in renal transplant recipient lymphatic complications: a randomized controlled trial.

Sigdel, P. R., et al.

International Urology & Nephrology 2021 [record in progress].


Aims
This study aimed to investigate lymphatic complications of bipolar vessel sealing system compared to silk ligation of lymphatic vessels following renal transplantation.

Interventions
Participants were randomised to either the silk ligation group or the bipolar vessel sealing group.

Participants
68 renal transplant recipients.

Outcomes
Lymphatic complications.

Follow-up
3 months

CET Conclusions
This paper reports the comparison of silk ligation of lymphatics versus bipolar cautery using the Ethicon ENSEAL device. The study was randomised but not blinded and there is no power calculation. Potentially a larger study would have been needed to find any difference in symptomatic lymphocoele as the reported rate was only 9% (not significantly different between study arms). Patients had a routine ultrasound scan at 6 and 12 weeks, which found fluid collections present in 25-30% of patients, with no significant difference between study arms. The study does not report how many patients required a drain to be reinserted after its first removal. The authors report a rate of 22% for significant lymphorrheoa, but this is defined as output over 50ml/day beyond day 5 and the wider significance of this is unclear from this study. There is a suggestion at the end that larger multicentre studies are required, but it seems to me that both the suture ligation and bipolar sealing have equally low rates of significant lymphocoele.

Jadad score
2

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
UMIN000039354

Funding source
No funding received