Randomized Controlled Trial of Enhanced Recovery After Surgery Protocols in Live Kidney Donors: ERASKT Study.
Saks, J., et al.Transplantation Direct 2024; 10(7): e1663.
Aims
The aim of this study was to assess whether the enhanced recovery after surgery (ERAS) protocol resulted in improved outcomes in living kidney donors postoperation.
Interventions
Participants were randomised to either the ERAS group or the conventional care (control) group.
Participants
46 patients (aged 18-80 years) with American Society of Anesthesiologists (ASA) Physical Status 1–3 scheduled to undergo living donor nephrectomy.
Outcomes
The primary endpoint was postoperative opioid consumption. The secondary endpoints included intraoperative fluid administration, pain scores postoperation, first oral intake and duration of hospital stay.
Follow-up
3 days postoperation.
CET Conclusions
This is a well-written report of a very interesting study in living kidney donation. Patients were enrolled in the study and then randomized by computer-generated list. The patient, surgeon and anaesthesiologist were blinded to the group allocation at that stage. In the lead up to surgery patients were given nutritional advice and education according to their allocation without specific reference to which group they were in by the unblinded nutritionist and transplant coordinator. The anaesthesiologist providing the TAP block was also clearly aware of the group allocation, but not involved in data collection. The study group received a comprehensive package of pre-op, intra-op and post-operative interventions. Post-operatively discharge was according to established criteria and decisions regarding nutrition and catheter removal were made by the blinded rounding surgeon. Altogether the investigating team took many steps to maintain blinding and prevent interference of placebo effect on the study outcome. The study was powered adequately based upon the primary outcome of post-operative opioid use. However, 6 patients were lost to follow up, a number also having had TAP block, and the analysis was then per-protocol rather than intention to treat. It is also possible that, despite the blinding measures taken, a systematic bias could not be completely prevented. However, the ERAS group had a significant reduction in opioid consumption within the first 48 hours, which is a robust and objective outcome. The pain scores are significantly improved in the ERAS group as well, and they had earlier catheter removal. On average they were discharged 10 hours earlier. Despite some concerns about blinding, this study does provide good evidence for the positive impact of a multi-modal ERAS pathway for living kidney donors.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT04110080