Status:

UNKNOWN

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

Lead Sponsor:

Asian Institute of Gastroenterology, India

Conditions:

Achalasia Cardia

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief 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 ach...

Detailed Description

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 there...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

December 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2020

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03784365

Start Date

December 1 2018

End Date

March 1 2020

Last Update

January 18 2020

Active Locations (1)

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1

Dr.Mohan Ramchandani

Hyderabad, RED ROSE Restaurant, India, 500082