Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study (SMAPP Trial).

Abstract

Infections are uncommon after peroral endoscopic myotomy (POEM) procedure. However, prophylactic antibiotics are routinely administered for variable duration during peri-operative period. In this study, we aimed to determine the difference in the rate of infections between single (SD-A) and multiple doses (MD-A) antibiotic prophylaxis groups. The study was a prospective, randomized, non-inferiority trial conducted at a single tertiary care centre from Dec 2018 to Feb 2020. Eligible patients undergoing POEM were randomized into SD-A and MD-A groups. SD-A group received one dose of antibiotic (IIIrd gen cephalosporin) within 30-min of POEM. In the MD-A group, the same antibiotic was administered for a total of three days. Primary aim of the study was to determine the incidence of infections in the two groups. Secondary outcomes included incidence of fever (> 100 °F), inflammatory markers [erythrocyte sedimentation rate (ESR), c-reactive protein(CRP)], serum procalcitonin and adverse events related to antibiotics. (NCT03784365). 114 patients were randomized to SD-A (57) and MD-A (57) antibiotic groups. Mean post-POEM CRP (0.8 ± 0.9 vs 1.5 ± 1.6), ESR (15.8 ± 7.8 20.6 ± 11.7) and procalcitonin (0.05 ± 0.04 0.29 ± 0.58) were significantly higher after POEM (p = 0.001). Post-POEM inflammatory markers (ESR, CRP and procalcitonin) were similar in both the groups. Fever on day-0 (10.5% vs 14%) and day-1 (1.7% vs 3.5%) was detected in similar proportion of patients. Post-POEM infections were recorded in 3.5% (1.7% vs 5.3%, p = 0.618). Single dose of antibiotic is non-inferior to multiple dose antibiotic prophylaxis. Elevation of inflammatory markers and fever after POEM represents inflammation and does not predict infection after POEM.

• Authors: Zaheer Nabi, Bhushan Bhaware, Mohan Ramchandani, Jahangeer Basha, Pradev Inavolu, Rama Kotla, Rajesh Goud, Santosh Darisetty, Duvvur Nageshwar Reddy
• Journal: Dysphagia (Dysphagia) Vol. 38 Issue 6 Pg. 1581-1588 (12 2023) ISSN: 1432-0460 [Electronic] United States
• PMID: 37142733 (Publication Type: Randomized Controlled Trial, Journal Article)
• Copyright: © 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Chemical References

• Procalcitonin
• Anti-Bacterial Agents

Topics

• Humans
• Esophageal Achalasia (etiology, surgery)
• Procalcitonin
• Prospective Studies
• Natural Orifice Endoscopic Surgery (adverse effects, methods)
• Treatment Outcome
• Anti-Bacterial Agents (therapeutic use)
• Myotomy (methods)
• Esophageal Sphincter, Lower (surgery)
• Retrospective Studies