Clinical Trials Logo
  1. Home
  2. Esophageal Achalasia
  3. NCT03404739

Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia

Esophageal Achalasia Clinical Trial

Official title:
Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia: A Triple-Blind, Randomized Controlled, Non-Inferiority Trial

Clinical Trial 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 focused on the efficacy, safety as well as technical aspects of POEM. 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. Other 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.

Thus, investigators intend to perform a prospective randomized study to confirm the validity of single-dose antimicrobial prophylaxis for the prevention of infectious complications following peroral endoscopic myotomy.

Clinical Trial 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 associated with peroral endoscopic myotomy. Six hundred sixty-six patients undergoing POEM for achalasia will be randomized to receive only single-dose ceftazidime (2g) or an additional 2 doses every 12 hours postoperatively (multi-dose group). POEM associated infectious complications will be assessed and recorded as regional infections, remote infections and systemic infections. Infection rate, adverse events related to antibiotics and POEM, Clavien-Dindo classification of surgical complications, length of hospital stay and efficacy of POEM will be compared. Body fluid bacterial culture will be conducted in patients suspected of infectious complications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03404739
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date October 1, 2017
Completion date January 2019
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962179 - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) N/A
Withdrawn NCT02663206 - Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders N/A
Active, not recruiting NCT00188344 - A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia N/A
Recruiting NCT04578769 - Assessment of Different Modified POEM for Achalasia N/A
Not yet recruiting NCT05010889 - Quality of Life After POEM for Achalasia
Recruiting NCT02572193 - To Assess the Feasibility of Same Day Discharge Following a POEM Procedure N/A
Terminated NCT02606578 - Achalasia Patient Reported Outcomes
Active, not recruiting NCT01750385 - Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia N/A
Completed NCT04112693 - Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study. N/A
Recruiting NCT05602272 - Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach
Recruiting NCT05113173 - Study on the Relationship Between Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
Completed NCT02999451 - Snare-assisted POEM for Treatment of Esophageal Achalasia N/A
Completed NCT00490750 - Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia N/A
Recruiting NCT02518542 - Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia N/A
Recruiting NCT00260585 - Esophageal Cancer Risk Registry
Recruiting NCT05899842 - Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia N/A
Completed NCT03702647 - Ropivacaine For Post-POEM Pain Control N/A
Recruiting NCT01637311 - Peroral Endoscopic Remyotomy for Failed Heller Myotomy N/A
Completed NCT00004416 - Randomized Study of Botulinum Toxin Type A for Achalasia N/A
Not yet recruiting NCT06027190 - Randomized Controlled Study of Optical 3D Navigated Repetitive Transcranial Magnetic Stimulation for Achalasia. N/A