Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia (SMAPP)

NCT03784365 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Asian Institute of Gastroenterology, India
Phase	Phase 3
Status	UNKNOWN
Enrolment	40
Start date	2018-12-01
Completion	2020-03

Conditions

• Achalasia Cardia

Interventions

• One dose of Cefo-perazone Sulbactum

Primary outcomes

• Infectious complications associated with POEM — 1 month
  The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups

Countries

India