Achalasia Cardia Clinical Trial
Official title:
Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently,
peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment
modality for achalasia.
Major adverse events are uncommon with POEM. Since the operator works close to mediastinum
during the POEM procedure, there is a potential for infectious complications. Therefore,
intravenous antibiotics are universally used to prevent infection-related adverse events.
There is no fixed protocol or duration of antibiotics for the same.
POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of
natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are
rare and therefore, the procedure is considered safe.
Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of
varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a
surrogate marker for risk of infection-related complications. In POEM procedure, the
endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the
potential for infection-related complications is high. However, despite of different
antibiotic protocols at different centers, the reported incidence of infection-related
complications is very low. At present, prophylactic antibiotics are universally initiated
before starting the POEM procedure and continued for a variable duration after POEM ranging
from 1 day to 7 days.
Data from surgical studies indicate that prolonged administration of antibiotics for longer
than 24 hours may not be beneficial. Prolonged use of antibiotics not only increases the
costs and exposure to drug toxicity directly but also may be associated with an increased
risk of acquired antibiotic resistance as well as infection with Clostridium difficile.
With this background, we planned a study to evaluate the difference in the infectious
complications between short vs long duration antibiotic in patients with achalasia undergoing
POEM.
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