Esophagus DisorderNCT03944863
Impact of Antibiotic Prophylaxis in Per-oral Endoscopic Myotomy for Esophageal Motor Disorders
An observational study of Esophagus Disorder and Esophageal Achalasia, run by Société Française d'Endoscopie Digestive.
Trial summary
No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Disorder, Esophageal Achalasia
- What is being tested?
- Antibiotics
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision. Under-age patients were excluded.
Who may be able to join
- Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision
Who cannot join
- Under-age patients were excluded
About this study
Official title: Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders
No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety.
This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.
- Conditions
- Esophagus Disorder, Esophageal Achalasia
- Being tested
- Antibiotics
- Keywords
- antibiotic prophylaxis, per oral endoscopic myotomy
- Medical subject headings
- Esophageal Diseases, Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
| Study group | Role | What they receive |
|---|---|---|
| POEM + Antibiotic prophylaxis | Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days Receives: Drug: Antibiotics | |
| POEM + No antibiotic prophylaxis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of postoperative complications, according to Cotton's classification
Depending on whether or not antibiotic prophylaxis was administered
Measured: 7 Days
Secondary outcomes (3)
The evaluation of the efficacy of the procedure
According to the Eckard score
Measured: 1 Month
The occurence of perioperative and postoperative complications
According to Cotton's classification
Measured: 7 Days
The C-Reactive Protein and white blood cells count sampled
Blood test the day after the procedure, level of CRP in mg/L
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study startDec 2013
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944863
- Sponsor's protocol ID
- Antibiotic Prophylaxis POEM
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders
- ClinicalTrials.gov ID
- NCT03944863
- Acronym / sponsor ID
- Antibiotic Prophylaxis POEM
- Conditions
- Esophagus Disorder, Esophageal Achalasia
- Keywords
- antibiotic prophylaxis, per oral endoscopic myotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety.
This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POEM + Antibiotic prophylaxis | – | Drug: AntibioticsCefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days |
| POEM + No antibiotic prophylaxis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision. Under-age patients were excluded.
Key inclusion criteria (1 listed)
- Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision
Key exclusion criteria (1 listed)
- Under-age patients were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics | Drug | POEM + Antibiotic prophylaxis |
Primary outcome
The occurence of postoperative complications, according to Cotton's classification
Time frame: 7 Days
Depending on whether or not antibiotic prophylaxis was administered
3 secondary outcomes
The evaluation of the efficacy of the procedure
Time frame: 1 Month
The occurence of perioperative and postoperative complications
Time frame: 7 Days
The C-Reactive Protein and white blood cells count sampled
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Disorder and Esophageal Achalasia, run by Société Française d'Endoscopie Digestive.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurence of postoperative complications, according to Cotton's classification (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.