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

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

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.

Study Overview

• Status: Unknown
• Conditions: Achalasia Cardia
• Intervention / Treatment: Drug: One dose of Cefo-perazone Sulbactum

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • RED ROSE Restaurant
    • Hyderabad, RED ROSE Restaurant, India, 500082
      • Recruiting
      • Dr.Mohan Ramchandani
      • Contact: Mohan Ramchandani; Phone Number: 8297918513; Email: ramchandanimohan@gmail.com
      • Contact: Zaheer Nabi; Phone Number: 9573058810; Email: zaheernabi1978@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First group; This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.	Drug: One dose of Cefo-perazone Sulbactum; Antibiotic; Other Names: Multiple doses of Cefo-perazone Sulbactum
Experimental: Second group; This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure	Drug: One dose of Cefo-perazone Sulbactum; Antibiotic; Other Names: Multiple doses of Cefo-perazone Sulbactum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of positive blood cultures	The main secondary outcome is difference in the incidence of positive blood cultures between the two groups	72 hours
Comparison of serum Procalcitonin between the two groups	Difference in the mean serum procalcitonin values between both the groups	72 hours
Comparison of inflammatory markers (CRP) between the two groups	Both the groups will be compared for mean blood C-reactive protein (CRP)	72 hours
Comparison of erythrocyte sedimentation rate (ESR) between the two groups	Both the groups will be compared for mean ESR at 1-hour	72 hours
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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Mohan Ramchandani, Asian institute of Gastroenterology, hyderabad, India

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: oesophageal aperistalsis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: SMAPP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No