SMAPPRandomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
One dose of Cefo-perazone Sulbactum
Deglutition Disorders+3
+ Digestive System Diseases
+ Esophageal Achalasia
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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