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

Last updated: January 14, 2020
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

3

Condition

Esophageal Disorders

Achalasia

Treatment

N/A

Clinical Study ID

NCT03784365
SMAPP-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All the patient(aged 18-65) who underwent POEM for achalasia cardia.

Exclusion

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 Design

Total Participants: 40
Study Start date:
December 01, 2018
Estimated Completion Date:
March 31, 2020

Study 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.

Connect with a study center

  • Dr.Mohan Ramchandani

    Hyderabad, RED ROSE Restaurant 500082
    India

    Active - Recruiting

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