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Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study
Zaheer Nabi1, Bhushan Bhaware2, Mohan Ramchandani2
1Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India. Zaheernabi1978@gmail.com.
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.
Insights
A single dose of antibiotic prophylaxis is as effective as multiple doses for peroral endoscopic myotomy (POEM) procedures. This finding suggests that shorter antibiotic durations can be safely used, reducing potential side effects and healthcare costs.
Area of Science:
- Gastroenterology
- Surgical Innovation
- Infectious Disease Prevention
Background:
- Peroral endoscopic myotomy (POEM) is a minimally invasive procedure for esophageal motility disorders.
- Prophylactic antibiotics are commonly used during POEM, but their optimal duration is debated.
- Reducing antibiotic exposure is crucial to combat antimicrobial resistance.
Purpose of the Study:
- To compare the incidence of infections between single-dose (SD-A) and multiple-dose (MD-A) antibiotic prophylaxis after POEM.
- To evaluate secondary outcomes including fever, inflammatory markers, and antibiotic-related adverse events.
Main Methods:
- A prospective, randomized, non-inferiority trial involving 114 patients undergoing POEM.
- Patients were randomized to receive either a single dose or three days of a third-generation cephalosporin.
- Infections, fever, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and procalcitonin levels were monitored.
Main Results:
- The incidence of post-POEM infections was similar between the SD-A and MD-A groups (3.5% overall; 1.7% vs 5.3%, p=0.618).
- Post-procedure inflammatory markers (CRP, ESR, procalcitonin) and fever rates were comparable in both groups.
- No significant difference in antibiotic-related adverse events was noted.
Conclusions:
- Single-dose antibiotic prophylaxis is non-inferior to multiple-dose prophylaxis for POEM.
- Elevated inflammatory markers and fever post-POEM likely indicate inflammation, not necessarily infection.
- These findings support de-escalation of antibiotic duration in POEM procedures.
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