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

• Status: Recruiting
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asian Institute of Gastroenterology, India
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular; Cephalosporins

Criteria

Inclusion Criteria:

• All the patient(aged 18-65) who underwent POEM for achalasia cardia.

Exclusion Criteria:

• Unwillingness to give written informed consent

• Patients with multiple co morbidities.

• Immunocompromised patients /on steroid therapy.

• Patients with indications for antibiotic prophylaxis (infective endocarditis).

• Patients who have received antibiotics in the last 1 week .

• Patients who have possible signs of infection during preparation for POEM