drugset / Trial / NCT03784365

Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia

NCT03784365 ↗

Phase 3 Unknown 40 enrolled Asian Institute of Gastroenterology, India
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2018-12-01
Primary completion
2020-02
Completion
2020-03

Outcome

Met primary endpoint

paper Single dose of antibiotic is non-inferior to multiple dose antibiotic prophylaxis. PMID 37142733 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefo-perazone Sulbactum Unknown — Intravenous

Indications