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Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systematic protein pump inhibitor therapy | Experimental |
| |
| Protein pump inhibitor therapy as necessary | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein pump inhibitor therapy systematically | Drug | Lansoprazole 30mg once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of pathological acid reflux between groups | According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure >6% on 24-hour esophageal pH-metry | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of pathological acid reflux between groups | According to the Lyon 2018 criteria: Esophagitis grade C or D according to the Los Angeles classification and/or acid exposure >6% on 24-hour esophageal pH-metry | Month 12 |
| Patient quality of life between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Debourdeau | Contact | 06.68.31.94.89 | a-debourdeau@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Debourdeau | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HM | Recruiting | Marseille | France |
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WHOQOL-BREF questionnaire |
| Week 6 |
| Patient quality of life between groups | WHOQOL-BREF questionnaire | Month 6 |
| Patient quality of life between groups | WHOQOL-BREF questionnaire | Month 12 |
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Week 6 |
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Month 6 |
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Month 12 |
| Quantity of PPI consumed between groups | Number of boxes of Lansoprazole consumed as recorded in PPI logbook | Month 3 |
| Quantity of PPI consumed between groups | Number of boxes of Lansoprazole consumed as recorded in PPI logbook | Month 6 |
| Quantity of PPI consumed between groups | Number of boxes of Lansoprazole consumed as recorded in PPI logbook | Month 12 |
| Treatment tolerance between groups | Occurrence of adverse events as recorded by the doctor during patient interview using a scale of Grade 1 (minor) to Grade 5 (death) | Month 12 |
| Achalasia symptoms between groups | Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms)) | Week 6 |
| Achalasia symptoms between groups | Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms)) | Month 6 |
| Achalasia symptoms between groups | Measured as Eckardt score >3 (score ranging from 0 (no symptoms)-12 (maximum symptoms)) | Month 12 |
| Pyrosis symptoms between groups | Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal | Month 6 |
| Pyrosis symptoms between groups | Classified according to Rome IV criteria: Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal | Month 12 |
| Patient quality of life between groups | WHOQOL-BREF questionnaire | Inclusion |
| Patient health-related quality of life between groups | Gastroesophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL) | Inclusion |
| CHU de Montpellier | Recruiting | Montpellier | France |
|
| Clinique mutualiste Beausoleil | Recruiting | Montpellier | France |
|
| CHU de Nîmes | Recruiting | Nîmes | France |
|
| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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