Skip to main content
Clinical Trials/NCT03784365
NCT03784365UnknownPhase 3

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

Asian Institute of Gastroenterology, India1 site in 1 country40 target enrollmentStarted: December 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Infectious complications associated with POEM

Study Overview

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 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.

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

First group

Active Comparator

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

Intervention: One dose of Cefo-perazone Sulbactum (Drug)

Second group

Experimental

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

Intervention: One dose of Cefo-perazone Sulbactum (Drug)

Outcomes

Primary Outcomes

Infectious complications associated with POEM

Time Frame: 1 month

The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups

Secondary Outcomes

  • Comparison of serum Procalcitonin between the two groups(72 hours)
  • Comparison of erythrocyte sedimentation rate (ESR) between the two groups(72 hours)
  • Incidence of positive blood cultures(72 hours)
  • Adverse events associated with administration of intravenous antibiotics(1-month)
  • Comparison of inflammatory markers (CRP) between the two groups(72 hours)

Investigators

Sponsor
Asian Institute of Gastroenterology, India
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohan Ramchandani

Consultant Gastroenterologist

Asian Institute of Gastroenterology, India

Study Sites (1)

Loading locations...

Similar Trials