Achalasia Cardia
Conditions
Keywords
oesophageal aperistalsis
Brief 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.
Detailed 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.
Interventions
DRUGOne dose of Cefo-perazone Sulbactum
Antibiotic
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* All the patient(aged 18-65) who underwent POEM for achalasia cardia.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infectious complications associated with POEM | 1 month | The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events associated with administration of intravenous antibiotics | 1-month | Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics |
| Comparison of erythrocyte sedimentation rate (ESR) between the two groups | 72 hours | Both the groups will be compared for mean ESR at 1-hour |
| Incidence of positive blood cultures | 72 hours | The main secondary outcome is difference in the incidence of positive blood cultures between the two groups |
| Comparison of serum Procalcitonin between the two groups | 72 hours | Difference in the mean serum procalcitonin values between both the groups |
| Comparison of inflammatory markers (CRP) between the two groups | 72 hours | Both the groups will be compared for mean blood C-reactive protein (CRP) |
Countries
India
Contacts
Primary ContactBhushan Bhaware
Outcome results
None listed