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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General information
Randomized
Not randomized
randnrand
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 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.
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.
جهت اصلاح متدولوژی و ارزیابی بهتر تاثیر پروسیجر به عنوان کارآزمایی بالینی گروه کنترل اضافه شد.
جهت اصلاح متدولوژی و ارزیابی بهتر تاثیر پروسیجر به عنوان کارآزمایی بالینی گروه کنترل اضافه شد.
برای جلوگیری از سوگیری در مطالعه هر دو روش به عنوان انجام پروسیجر یا ادامه با دارو به بیماران توضیح داده شد و انتخاب گروه با نظر بیمار بود که در ارائه قبلی اصلاح نشده بود.
جهت اصلاح متدولوژی و ارزیابی بهتر تاثیر پروسیجر به عنوان کارآزمایی بالینی گروه کنترل اضافه شد. برای جلوگیری از سوگیری در مطالعه هر دو روش به عنوان انجام پروسیجر یا ادامه با دارو به بیماران توضیح داده شد و انتخاب گروه با نظر بیمار بود که در ارائه قبلی اصلاح نشده بود.
Patients are assigned to two groups using the random block method. The number of blocks will be 2, and in each block 24 patients will be included in the study order. Random allocation of blocks of patients to two treatment groups will be done through the online sealed envelope software. The blocks are placed in sealed envelopes and will be available to prescribers daily.
Patients are assigned to two groups using the random block method. The number of blocks will be 2, and in each block 24 patients will be included in the study order. Random allocation of blocks of patients to two treatment groups will be done through the online sealed envelope software. The blocks are placed in sealed envelopes and will be available to prescribers daily.
بیماران با استفاده از روش بلوک های تصادفی به دو گروه تخصیص داده می شود. تعداد بلوک ها 2 تا خواهد بود و در هر بلوک 24 بیمار بر اساس ترتیب ورود به مطالعه قرار می گیرند. تخصیص تصادفی بلوک های بیماران به دو گروه درمانی از طریق نرم افزارآنلاین sealed envelope انجام خواهد شد. بلوک ها در پاکت های دربسته قرار داده شده و به طور روزانه در اختیار تجویز کننده ها قرارا خواهد گرفت.
بیماران با استفاده از روش بلوک های تصادفی به دو گروه تخصیص داده می شود. تعداد بلوک ها 2 تا خواهد بود و در هر بلوک 24 بیمار بر اساس ترتیب ورود به مطالعه قرار می گیرند. تخصیص تصادفی بلوک های بیماران به دو گروه درمانی از طریق نرم افزارآنلاین sealed envelope انجام خواهد شد. بلوک ها در پاکت های دربسته قرار داده شده و به طور روزانه در اختیار تجویز کننده ها قرارا خواهد گرفت.
Protocol summary
Study aim
Investigating the safety and effectiveness of anti reflux mucosal ablation (ARMA) in improving reflux symptoms in patients resistant to treatment with proton pump inhibitors
Design
Clinical trial with control group, with parallel group randomized trial with single blinded, convenience sampling on 48 patients with refractory reflux
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Heartburn, hiatal hernia, flatulence, sore throat, dysphagia, heaviness after eating, quality of life
General information
Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
Mina Moghtaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 0065
Email address
minamoghtaderi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
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)
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Koodakyar St. Danshjoo Blv, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.SBMU.RIGLD.REC.1402.003
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux disease
ICD-10 code
K21.9
ICD-10 code description
Gastro-esophageal reflux disease without esophagitis
Primary outcomes
1
Description
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)
Timepoint
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
Method of measurement
Gastroesophageal reflux disease-related quality of life questionnaire (GERD-HRQL), assessment of the frequency of gastroesophageal reflux disease symptoms (FSSG), upper endoscopy
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology and Liver Clinic, Taleghani Hospital
Full name of responsible person
Mina Moghtaderi
Street address
Research Center of Gastroenterology and Liver Diseases, Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 23031
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
School of Medicine, Koodakyar St. Danshjoo Blv, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 23871
Email
Dean.medicalschool@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Moghtaderi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gastroentrohepatologist
Street address
Gastroenterology and Liver Research Center, Taleghani Hospital, Arabi St., Valenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Fax
Email
Minamoghtaderi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Moghtaderi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Research Center, Taleghani Hospital, Arabi St., Valenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Fax
Email
Minamoghtaderi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Moghtaderi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Research Center, Taleghani Hospital, Arabi St., Valenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Fax
Email
Minamoghtaderi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD