Clinical Trials Logo

Clinical Trial Summary

Achalasia cardia is a primary oesophageal motility disorder of unknown etiology. Recently, peroral endoscopic myotomy (POEM) has gained widespread acceptance as an effective treatment modality for achalasia.

Major adverse events are uncommon with POEM. Since the operator works close to mediastinum during the POEM procedure, there is a potential for infectious complications. Therefore, intravenous antibiotics are universally used to prevent infection-related adverse events. There is no fixed protocol or duration of antibiotics for the same.


Clinical Trial Description

POEM is a novel minimally invasive treatment for achalasia, which emerged as an offshoot of natural orifice transluminal endoscopic surgery (NOTES). Major adverse events during POEM are rare and therefore, the procedure is considered safe.

Bacteremia can occur after endoscopic procedures like esophageal dilation, sclerotherapy of varices, and instrumentation of obstructed bile ducts. Bacteremia has been advocated as a surrogate marker for risk of infection-related complications. In POEM procedure, the endoscopist works in close proximity to mediastinum and peritoneal cavity. Therefore, the potential for infection-related complications is high. However, despite of different antibiotic protocols at different centers, the reported incidence of infection-related complications is very low. At present, prophylactic antibiotics are universally initiated before starting the POEM procedure and continued for a variable duration after POEM ranging from 1 day to 7 days.

Data from surgical studies indicate that prolonged administration of antibiotics for longer than 24 hours may not be beneficial. 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.

With this background, we planned a study to evaluate the difference in the infectious complications between short vs long duration antibiotic in patients with achalasia undergoing POEM. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03784365
Study type Interventional
Source Asian Institute of Gastroenterology, India
Contact Bhushan Bhaware
Phone 9833022139
Email drbhushanbhaware3@gmail.com
Status Recruiting
Phase Phase 3
Start date December 1, 2018
Completion date March 2020

See also
  Status Clinical Trial Phase
Recruiting NCT06189859 - Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy Phase 3
Completed NCT03186248 - Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia. N/A
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT04951739 - To Investigate the Incidence of Reflux in Patients After Per-oral Endoscopic Myotomy in Achalasia Cardia Patients
Active, not recruiting NCT03438838 - Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia N/A
Active, not recruiting NCT06290882 - Endoscopic Versus Robotic Myotomy for Treatment of Achalasia N/A
Completed NCT05729971 - Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
Recruiting NCT02025790 - POEM Versus Pneumatic Dilatation in Achalasia Cardia N/A