PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial.
Golriz, M., et al.BMJ Open 2020; 10(10): e032286.
Aims
This protocol aims to examine the preventative effect of metal clips around the edges of a small fenestration on post-kidney transplantation lymphatic complications (PKTL).
Interventions
Participants will be randomised to one of two groups: with small fenestration only or with small fenestration and clipping around the edges.
Participants
Deceased donor kidney transplant reicipients.
Outcomes
The primary outcome is the incidence of post-transplant symptomatic lymphatic complications. The secondary outcomes include estimated blood loss, duration of operation, surgical complications, length of hospital stay, postoperative complications, all-cause mortality, total perirenal fluid accumulation, serum creatinine levels, blood urea nitrogen (BUN) level, glomerural filtration rate (GFR), delayed graft function and primary non-function.
Follow-up
6 months
CET Conclusions
This is the protocol for an interesting RCT in renal transplantation. Whilst there is prior existing evidence regarding prophylactic peritoneal fenestration, and even the size of fenestration, there is no evidence regarding clipping the edges of the window. The study protocol has good descriptions of the randomisation methods, blinding methods and statistical analysis. The power calculation has been done to detect a small difference in incidence (only 5%) at 6 months follow up, which may be too small to be clinically significant in the face of any potential complication, such as intestinal herniation.
Trial registration
ClinicalTrials.gov - NCT03682627