Protocol summary
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Study aim
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Investigating the safety and effectiveness of anti reflux mucosal ablation (ARMA) in improving reflux symptoms in patients resistant to treatment with proton pump inhibitors
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Design
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Clinical trial with control group, with parallel group randomized trial with single blinded, convenience sampling on 48 patients with refractory reflux
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Settings and conduct
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The intervention in Taleghani Hospital was performed in a randomized manner and with blinding of one strain in the person evaluating the result
For the intervention group, mucosal ablation is performed on the side of the cardia at the EGJ site with a circumference of about 270 degrees. All patients are treated with S-Omeprazole 20 mg every 12 hours after the intervention.Control group patients are treated with S-Omeprazole every 12 hours without performing the procedure. Patients are followed up monthly by phone to check adherence to drug treatment. After one and three months, the GERD-HRQL and FSSG questionnaires were completed again for the patients. After 3 months, all patients undergo gastroscopy. Side effects will also be reviewed.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients aged 20 to 65 years, at least one typical symptom of reflux more than 2 times a week in the last six months, sliding hiatal hernia, minimum Hill grade one and maximum three, and informed consent. Exclusion criteria: pregnancy, age less than 20 years, primary esophageal motility disorders, sliding hiatal hernia more than 3 cm and Hill degree 4
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Intervention groups
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Patients in the intervention group undergo endoscopy after 6 hours of fasting and are subjected to ablation of 270 degrees by argon gas in the cardia.
Patients in the control group are treated with omeprazole 20 mg every 12 hours.
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Main outcome variables
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Heartburn, hiatal hernia, flatulence, sore throat, dysphagia, heaviness after eating, quality of life
General information
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Reason for update
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In order to improve the methodology and better evaluate the effect of the procedure, a control group was added as a clinical trial.
In order to avoid bias in the study, both methods were explained to the patients as performing the procedure or continuing with the drug, and the selection of the group was based on the patient's opinion, which was not modified in the previous presentation.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200217046520N2
Registration date:
2023-10-03, 1402/07/11
Registration timing:
registered_while_recruiting
Last update:
2024-04-25, 1403/02/06
Update count:
2
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Registration date
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2023-10-03, 1402/07/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-10-02, 1402/07/10
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Expected recruitment end date
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2024-02-29, 1402/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of anti-reflux mucosal ablation (ARMA) in reducing the symptoms of esophageal reflux (GERD) in patients resistant to treatment with proton pump inhibitors (PPI)
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Public title
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Investigating the effect of anti-reflux mucosal ablation (ARMA) in reducing the symptoms of esophageal reflux (GERD) in patients resistant to treatment with proton pump inhibitors (PPI)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 20 and 65 years
At least one typical symptom of reflux more than twice a week
Sliding hiatal hernia
Hill grade minimum I and maximum III
Exclusion criteria:
Pregnancy
Primary motility disorders of the esophagus
Hiatal hernia sliding more than 3 cm
Hill grade IV
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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To avoid bias in evaluating the results, the person who examines the results of the intervention effects does not know which group was subjected to ARMA or the control group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-04, 1402/06/13
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Ethics committee reference number
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IR.SBMU.RIGLD.REC.1402.003
Health conditions studied
1
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Description of health condition studied
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Gastroesophageal reflux disease
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ICD-10 code
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K21.9
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ICD-10 code description
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Gastro-esophageal reflux disease without esophagitis
Primary outcomes
1
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Description
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The reduction of reflux symptoms in gastroesophageal reflux disease-related quality of life questionnaire (GERD-HRQL) and the frequency of gastroesophageal reflux disease symptoms (FSSG)
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Timepoint
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Measurement of patients' symptoms based on questionnaires at the beginning of the study (before the start of the intervention) and 1 and 3 months after anti reflux mucosal ablation
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Method of measurement
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Gastroesophageal reflux disease-related quality of life questionnaire (GERD-HRQL), assessment of the frequency of gastroesophageal reflux disease symptoms (FSSG), upper endoscopy
Intervention groups
1
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Description
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Intervention group: 24 patients aged 20 to 65 with reflux resistant to treatment with proton pump inhibitors, referring to Gastroenterology Clinic in Taleghani hospital, first complete the GERD-HRQL and FSSG questionnaires and then undergo endoscopy and ARMA And then 1 month and 3 months later, the questionnaires are completed again, and after 3 months, endoscopy is performed again. Data analysis is done using SPSS version 26 software. P less than 0.05 is considered as statistically significant level.
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Category
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Treatment - Other
2
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Description
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Control group: 24 patients aged 20 to 65 with reflux resistant to treatment with proton pump inhibitors referred to the gastroenterology clinic of Taleghani Hospital, first completed the GERD-HRQL and FSSG questionnaires and then were treated with 20 mg of omeprazole. They are placed every 12 hours, and then 1 month and 3 months later, the questionnaires are completed again, and after 3 months, endoscopy is performed again. Data analysis is done using SPSS version 26 software. P less than 0.05 is considered as statistically significant level.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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there is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available