Background

Chemical pyloroplasty (CP) using botulinum toxin benefits patients after esophagectomy or with gastroparesis by muscular relaxation of the pylorus. CP has not been studied as an adjunct to bariatric surgery.

Methods

Prospective, double-blinded, randomized clinical trial of patients undergoing sleeve gastrectomy (SG), comparing those treated by CP to those treated by placebo. Either saline containing 100u botulinum toxin or saline only are injected into the pylorus at the termination of SG. Primary outcomes are postoperative use of antiemetic medications and hospital length of stay. Secondary outcomes include patient-reported nausea scores, 30-day hospital readmission rate and complication rate.

Results

Out of 54 patients randomized to the protocol, preliminary analysis demonstrates that when comparing patients treated with CP versus those treated with placebo, there was no difference in adverse outcomes. In addition, there was no significant difference in the mean doses of postoperative antiemetic medication (0.9 vs. 1, p = 0.87); mean hospital length of stay (1.6 vs. 1.5, p = 0.6); patient reported mean episodes of nausea (1.5 vs. 2.2, p = 0.07); or overall mean satisfaction scores (4.2 vs. 4.6, p = 0.13).

Conclusions

A pilot study demonstrates that CP during SG is safe but does not have significantly different effect on postoperative outcomes when compared to placebo. An ongoing randomized controlled trial that was limited by the COVID-19 pandemic may demonstrate significant differences in patient outcomes.