Suspended

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

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What is being tested

One dose of Cefo-perazone Sulbactum

Drug
Who is being recruted

Deglutition Disorders+3

+ Digestive System Diseases

+ Esophageal Achalasia

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2018
See protocol details

Summary

Principal SponsorAsian Institute of Gastroenterology, India
Study ContactBhushan Bhaware
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleRandomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
NCT03784365
Principal SponsorAsian Institute of Gastroenterology, India
Study ContactBhushan Bhaware
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal AchalasiaEsophageal DiseasesGastrointestinal DiseasesEsophageal Motility Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Dr.Mohan Ramchandani

Hyderabad, IndiaOpen Dr.Mohan Ramchandani in Google Maps
SuspendedOne Study Center