Status:
UNKNOWN
Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Esophageal Achalasia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Peroral endoscopic myotomy is a novel, promising endoscopic technique for achalasia considering its minimal invasive characteristics and comparable efficacy to Heller myotomy. Numerous studies have fo...
Detailed Description
This prospective randomized trial is performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of infectious complications associa...
Eligibility Criteria
Inclusion
- Diagnosed of esophageal achalasia
- Patients or legal surrogates willing and competent to give informed consent and to comply with follow up visits and tests
Exclusion
- Patients with ASA score ≥3
- Patients with indications for antibiotic prophylaxis(infective endocarditis or other conditions) as determined by the American Society for Gastrointestinal Endoscopy
- Patients who have received antibiotics in the past seven days
- Patients who have possible signs of infection during preparation for POEM
- Pregnant
- Immunodeficient patients such as severe neutropenia(\<0.5x1068/l) and/or advanced hematological malignancy
- Under steroid therapy
- Patients who develop intraoperative severe adverse events including severe choking and aspiration during endotracheal intubation requiring antibiotic treatment as well as severe pneumothorax, perforation, bleeding and mucosal injury cannot be closed by clips.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT03404739
Start Date
October 1 2017
End Date
January 1 2019
Last Update
November 7 2018
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032