Intraoperative botulinum toxin injection in sleeve gastrectomy, a pilot randomized controlled trial.

[BACKGROUND] Botulinum toxin injection of the pylorus (BP) improves gastric transit after esophagectomy (Saeed et al. in Surg Endosc 38(10):6046-52, 2024). At our institution, BP has been used as an adjunct to sleeve gastrectomy (SG) to reduce post-operative nausea and vomiting (PONV). We studied the safety and efficacy of this practice.

[METHODS] A prospective, double-blinded randomized controlled trial of SG was performed with and without intraoperative BP at a large tertiary care medical center over a 3-year period was done. The primary outcome measured was safety of intraoperative BP during SG and followed by efficacy in treating PONV.

[RESULTS] We performed a prospective RCT on 57 SGs performed from 2019 to 2022. There were no differences in operative time (106.8 min BP vs. 106.4 min placebo, p = 0.94) and length of stay (1.68 days BP vs. 1.48 days placebo, p = 0.40). There were no intraoperative complications and one 30-day readmission for chest pain and dehydration in the placebo group. Utilization of outpatient hydration was equivalent (7.14% BP vs 6.90% placebo, p > 0.99). Anti-emetic usage (53.57% BP and 58.62% placebo, p = 0.70) and self-reported nausea (46.43% BP and 51.72% cohort, p = 0.79) were comparable.

[CONCLUSION] Intraoperative BP during SG is safe but does not improve peri-operative outcomes or patient-reported PONV when compared to standard ERAS measures. We were limited by reduction in elective bariatric case volume during the pandemic. Future study administering botulinum toxin preoperatively during endoscopy may be more successful.