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

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ClinicalTrials.gov Identifier: NCT03784365
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mohan Ramchandani, Asian Institute of Gastroenterology, India

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.


Condition or disease Intervention/treatment Phase
Achalasia Cardia Drug: One dose of Cefo-perazone Sulbactum Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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 Name: Multiple doses of Cefo-perazone Sulbactum




Primary Outcome Measures :
  1. Infectious complications associated with POEM [ Time Frame: 1 month ]
    The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups


Secondary Outcome Measures :
  1. Incidence of positive blood cultures [ Time Frame: 72 hours ]
    The main secondary outcome is difference in the incidence of positive blood cultures between the two groups

  2. Comparison of serum Procalcitonin between the two groups [ Time Frame: 72 hours ]
    Difference in the mean serum procalcitonin values between both the groups

  3. Comparison of inflammatory markers (CRP) between the two groups [ Time Frame: 72 hours ]
    Both the groups will be compared for mean blood C-reactive protein (CRP)

  4. Comparison of erythrocyte sedimentation rate (ESR) between the two groups [ Time Frame: 72 hours ]
    Both the groups will be compared for mean ESR at 1-hour

  5. Adverse events associated with administration of intravenous antibiotics [ Time Frame: 1-month ]
    Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784365


Contacts
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Contact: Bhushan Bhaware 9833022139 drbhushanbhaware3@gmail.com

Locations
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India
Dr.Mohan Ramchandani Recruiting
Hyderabad, RED ROSE Restaurant, India, 500082
Contact: Mohan Ramchandani    8297918513    ramchandanimohan@gmail.com   
Contact: Zaheer Nabi    9573058810    zaheernabi1978@gmail.com   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Principal Investigator: Mohan Ramchandani Asian Institute of Gastroenterology, Hyderabad, India
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Responsible Party: Mohan Ramchandani, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT03784365    
Other Study ID Numbers: SMAPP-01
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohan Ramchandani, Asian Institute of Gastroenterology, India:
oesophageal aperistalsis
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases