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Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia (SMAPP)

Primary Purpose

Achalasia Cardia

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
One dose of Cefo-perazone Sulbactum
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia Cardia focused on measuring oesophageal aperistalsis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr.Mohan RamchandaniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

First group

Second group

Arm Description

This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.

This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure

Outcomes

Primary Outcome Measures

Infectious complications associated with POEM
The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups

Secondary Outcome Measures

Incidence of positive blood cultures
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
Difference in the mean serum procalcitonin values between both the groups
Comparison of inflammatory markers (CRP) between the two groups
Both the groups will be compared for mean blood C-reactive protein (CRP)
Comparison of erythrocyte sedimentation rate (ESR) between the two groups
Both the groups will be compared for mean ESR at 1-hour
Adverse events associated with administration of intravenous antibiotics
Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics

Full Information

First Posted
December 20, 2018
Last Updated
January 14, 2020
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT03784365
Brief Title
Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Acronym
SMAPP
Official Title
Randomized Control Study Comparing Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia Cardia
Keywords
oesophageal aperistalsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First group
Arm Type
Active Comparator
Arm Description
This group will receive an intravenous antibiotic for three days. The first dose will be given within half hour before the POEM procedure.
Arm Title
Second group
Arm Type
Experimental
Arm Description
This group will receive only one dose of intravenous antibiotic within half hour before the POEM procedure
Intervention Type
Drug
Intervention Name(s)
One dose of Cefo-perazone Sulbactum
Other Intervention Name(s)
Multiple doses of Cefo-perazone Sulbactum
Intervention Description
Antibiotic
Primary Outcome Measure Information:
Title
Infectious complications associated with POEM
Description
The primary outcome of the study is to estimate the difference in the incidence of infectious complications in the two groups
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Incidence of positive blood cultures
Description
The main secondary outcome is difference in the incidence of positive blood cultures between the two groups
Time Frame
72 hours
Title
Comparison of serum Procalcitonin between the two groups
Description
Difference in the mean serum procalcitonin values between both the groups
Time Frame
72 hours
Title
Comparison of inflammatory markers (CRP) between the two groups
Description
Both the groups will be compared for mean blood C-reactive protein (CRP)
Time Frame
72 hours
Title
Comparison of erythrocyte sedimentation rate (ESR) between the two groups
Description
Both the groups will be compared for mean ESR at 1-hour
Time Frame
72 hours
Title
Adverse events associated with administration of intravenous antibiotics
Description
Both the groups will be compared for the incidence of complications associated with the use of intravenous antibiotics
Time Frame
1-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bhushan Bhaware
Phone
9833022139
Email
drbhushanbhaware3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohan Ramchandani
Organizational Affiliation
Asian Institute of Gastroenterology, Hyderabad, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr.Mohan Ramchandani
City
Hyderabad
State/Province
RED ROSE Restaurant
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohan Ramchandani
Phone
8297918513
Email
ramchandanimohan@gmail.com
First Name & Middle Initial & Last Name & Degree
Zaheer Nabi
Phone
9573058810
Email
zaheernabi1978@gmail.com

12. IPD Sharing Statement

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Single-Versus Multiple-dose Antimicrobial Prophylaxis for Peroral Endoscopic Myotomy in Achalasia

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