Clinical trial NCT03784365: Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Official title: Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Achalasia Cardia
Keywords: oesophageal aperistalsis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Infectious complications associated with POEM
timeFrame: 1 month
Secondary outcomes:
measure: Incidence of positive blood cultures
timeFrame: 72 hours
measure: Comparison of serum Procalcitonin between the two groups
timeFrame: 72 hours
measure: Comparison of inflammatory markers (CRP) between the two groups
timeFrame: 72 hours
measure: Comparison of erythrocyte sedimentation rate (ESR) between the two groups
timeFrame: 72 hours
measure: Adverse events associated with administration of intravenous antibiotics
timeFrame: 1-month
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dr.Mohan Ramchandani
state: RED ROSE Restaurant
Study officials:
affiliation: Asian Institute of Gastroenterology, Hyderabad, India
name: Mohan Ramchandani
role: PRINCIPAL_INVESTIGATOR
References: