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

Achalasia Cardia Clinical Trial

— SMAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03784365
• Other study ID #: SMAPP-01
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2018
• Est. completion date: March 2020

Study information

• Verified date: January 2020
• Source: Asian Institute of Gastroenterology, India
• Contact: Bhushan Bhaware
• Phone: 9833022139
• Email: drbhushanbhaware3[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Achalasia Cardia
• Esophageal Achalasia

Intervention

Drug:
• One dose of Cefo-perazone Sulbactum
Antibiotic

Locations

Country	Name	City	State
India	Dr.Mohan Ramchandani	Hyderabad	RED ROSE Restaurant

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications associated with POEM	The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups	1 month
Secondary	Incidence of positive blood cultures	The main secondary outcome is difference in the incidence of positive blood cultures between the two groups	72 hours
Secondary	Comparison of serum Procalcitonin between the two groups	Difference in the mean serum procalcitonin values between both the groups	72 hours
Secondary	Comparison of inflammatory markers (CRP) between the two groups	Both the groups will be compared for mean blood C-reactive protein (CRP)	72 hours
Secondary	Comparison of erythrocyte sedimentation rate (ESR) between the two groups	Both the groups will be compared for mean ESR at 1-hour	72 hours
Secondary	Adverse events associated with administration of intravenous antibiotics	Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics	1-month