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

Asian Institute of Gastroenterology, India

Status and phase: Unknown; Phase 3

Conditions: Achalasia Cardia

Treatments: Drug: One dose of Cefo-perazone Sulbactum

Study type: Interventional

Funder types: Other

Identifiers

NCT03784365

SMAPP-01

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

First group

Active Comparator group

Description:

This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.

Treatment:

Drug: One dose of Cefo-perazone Sulbactum

Second group

Experimental group

Description:

This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure

Treatment:

Drug: One dose of Cefo-perazone Sulbactum