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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 : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mohan Ramchandani, Asian Institute of Gastroenterology, India

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
estimate the % of bacteremia associated with POEM. [ Time Frame: 1 month ]
The primary outcome of the study is to estimate the % of bacteremia associated with POEM.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Official Title  ICMJE Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Brief Summary

Achalasia cardia is a primary oesophageal motility disorder of unknown etiology characterized manometrically by oesophageal aperistalsis and insufficient relaxation of the lower oesophageal sphincter (LES) in response to deglutition. Causative mechanism is unknown but may be related to genetic predisposition or autoimmunity.

Because of the unknown aetiology of achalasia, a curative treatment is not available.

Palliative treatment options are aimed to reduce the gradient across the LES, alleviating the primary symptoms of dysphagia and regurgitation, improving esophageal emptying, and preventing the development of megaesophagus.

Detailed Description

Treatment modalities include pharmacological therapy, endoscopic injection of botulinum toxin (Botox), pneumatic dilatation (PD), Laparoscopic Heller Myotomy (LHM) and Per Oral Endoscopic Myotomy (POEM). POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). No longer considered as an experimental treatment POEM has achieved remarkable initial outcomes for treating achalasia with approximately 10,000 procedures performed worldwide till date. Numerous studies have focused on the efficacy, safety as well as technical aspects of POEM.

Bacteremia can occur after endoscopic procedures and has been advocated as a surrogate marker for IE risk. The highest rates of bacteremia have been reported with esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts.

However, few efforts have been made to the issue of antimicrobial prophylaxis in POEM. Postoperative prophylactic antibiotics are universally initiated on call to the operating room or at the start of POEM and consist of second-generation cephalosporins. The mean duration of antibiotic regimen after POEM was 3 days ranging from 1 day to 7 days.

Numerous studies have shown that a single dose of antibiotic prophylaxis in a variety of surgical procedures. Few studies have shown that prolonged administration of antibiotics for longer than 24 hours add no benefit in many surgeries. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Achalasia Cardia
Intervention  ICMJE Drug: 3Rd Generation Cephalosporins
Antibiotic
Other Name: β-lactam antibiotics
Study Arms  ICMJE
  • Active Comparator: First group
    will receive only one antibiotic(3rd generation cephalosporins) before the procedure
    Intervention: Drug: 3Rd Generation Cephalosporins
  • Experimental: Second group
    will receive antibiotic(3rd generation cephalosporins) for three subsequent days.Post POEM procedure,blood cultures were drawn after 6hour of procedure and Day 3.
    Intervention: Drug: 3Rd Generation Cephalosporins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bhushan Bhaware 9833022139 drbhushanbhaware3@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03784365
Other Study ID Numbers  ICMJE SMAPP-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohan Ramchandani, Asian Institute of Gastroenterology, India
Study Sponsor  ICMJE Asian Institute of Gastroenterology, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohan Ramchandani Asian Institute of Gastroenterology, Hyderabad, India
PRS Account Asian Institute of Gastroenterology, India
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP