Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia
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|ClinicalTrials.gov Identifier: NCT03404739|
Recruitment Status : Unknown
Verified January 2018 by Shanghai Zhongshan Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 19, 2018
Last Update Posted : November 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Drug: Saline Solution Drug: Ceftazidime||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||666 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||single- versus multiple-dose antimicrobial prophylaxis|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Sequentially numbered, opaque sealed envelopes(SNOSE) will be the method to conceal allocation from the study team.|
|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|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Single-dose group
Ceftazidime 2g at the start of POEM
Drug: Saline Solution
These patients will be given only one dose of ceftazidime at the start of POEM plus 2 doses of saline solution every 12 hours after the procedure.
Active Comparator: Multiple-dose group
Ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure
These patients will be given ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure.
- Infectious complications associated with POEM [ Time Frame: From operation day to 4 weeks after the procedure ]Including regional, remote and systemic infections.
- Pathogens for causing infection [ Time Frame: From operation day to 4 weeks after the procedure ]Body fluid will be collected and cultured in patients suspected of infectious complications
- Adverse effects of antibiotics [ Time Frame: From operation day to 4 weeks after the procedure ]Any adverse events related to ceftazidime will be recorded.
- Clavien-Dindo classification of surgical complications [ Time Frame: From operation day to 4 weeks after the procedure ]Clavien-Dindo classification of surgical complications is recorded if adverse events happen related to POEM
- Length of hospital stay [ Time Frame: From admission to discharge ]Length of hospital stay will be extracted.
- Efficacy of POEM [ Time Frame: admission to 4 weeks after POEM ]Eckardt score will be compared before and after POEM.Clinical scoring system for achalasia (Eckardt score) Score Symptom Weight loss (kg)(0-3), Dysphagia(0-3), Retrosternal pain(0-3), Regurgitation(0-3)
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): NCT03404739
|Zhongshan Hospital, Fudan University|
|Shanghai, Shanghai, China, 200032|
|Study Chair:||Ping-Hong Zhou, MD, PhD||Zhongshan Hospital, Fudan University, Shanghai, China|