NCT03784365

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

December 20, 2018

Last Update Submit

January 14, 2020

Conditions

Achalasia Cardia

Keywords

oesophageal aperistalsis

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Secondary Outcomes (5)

  • Incidence of positive blood cultures

    72 hours

  • Comparison of serum Procalcitonin between the two groups

    72 hours

  • Comparison of inflammatory markers (CRP) between the two groups

    72 hours

  • Comparison of erythrocyte sedimentation rate (ESR) between the two groups

    72 hours

  • Adverse events associated with administration of intravenous antibiotics

    1-month

Study Arms (2)

First group

ACTIVE COMPARATOR

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

Drug: One dose of Cefo-perazone Sulbactum

Second group

EXPERIMENTAL

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

Drug: One dose of Cefo-perazone Sulbactum

Interventions

One dose of Cefo-perazone SulbactumDRUG

Antibiotic

Also known as: Multiple doses of Cefo-perazone Sulbactum
First groupSecond group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patient(aged 18-65) who underwent POEM for achalasia cardia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Mohan Ramchandani

Hyderabad, RED ROSE Restaurant, 500082, India

RECRUITING

Related Publications (1)

  • Nabi Z, Bhaware B, Ramchandani M, Basha J, Inavolu P, Kotla R, Goud R, Darisetty S, Reddy DN. Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study (SMAPP Trial). Dysphagia. 2023 Dec;38(6):1581-1588. doi: 10.1007/s00455-023-10585-y. Epub 2023 May 4.

    PMID: 37142733DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Mohan Ramchandani

    Asian Institute of Gastroenterology, Hyderabad, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhushan Bhaware

CONTACT

9833022139drbhushanbhaware3@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterologist

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 21, 2018

Study Start

December 1, 2018

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

IN(1)