Effect of helicobacter pylori treatment versus placebo on the prevention of the recurrence of sinonasal polyps after functional endoscopic surgery: a triple-blind randomized clinical trial
To assess the effect of helicobacter pylori treatment versus placebo on the prevention of the recurrence of sinonasal polyps after functional endoscopic surgery
Design
This is a triple-blind randomized clinical trial, phase III, in which 50 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with sinonasal polyps who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be triple-blinded so that neither patients nor the physician will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Sinonasal polyps,
Helicobacter pylori antigen positive
Exclusion criteria:
Dyspepsia or peptic ulcer or gastritis,
Chronic abstractive pulmonary disease
Intervention groups
Intervention group:
Sinonasal polyps surgery by functional endoscopic plus nasal Fluticasone spray one puff every 12 hours, tablet Cefixime 400 mg once daily, tablet Loratadine 10 mg every 12 hours, and nasal irrigation three times daily for 2 weeks as well as Helicobacter pylori treatment with four-drug regimen including capsule Amoxicillin 1 g every 12 hours, tablet metronidazole 500 mg every 12 hours, tablet bismuth 420 mg every 12 hours, and tablet Pantoprazole 40 mg every 12 hours for 2 weeks
Control group:
Sinonasal polyps surgery by functional endoscopic plus nasal Fluticasone spray one puff every 12 hours, tablet Cefixime 400 mg once daily, tablet Loratadine 10 mg every 12 hours, and nasal irrigation three times daily for 2 weeks as well as tablet placebo every 12 hours for 2 weeks
Main outcome variables
Primary outcome:
The recurrence of sinonasal polyps
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N309
Registration date:2019-10-17, 1398/07/25
Registration timing:retrospective
Last update:2019-10-17, 1398/07/25
Update count:0
Registration date
2019-10-17, 1398/07/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of helicobacter pylori treatment versus placebo on the prevention of the recurrence of sinonasal polyps after functional endoscopic surgery: a triple-blind randomized clinical trial
Public title
Effect of helicobacter pylori treatment versus placebo on the prevention of the recurrence of sinonasal polyps after functional endoscopic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Sinonasal polyps,
Helicobacter pylori antigen positive
Exclusion criteria:
Dyspepsia or peptic ulcer or gastritis,
Chronic abstractive pulmonary disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.UMSHA.REC.1397.92
Health conditions studied
1
Description of health condition studied
Nasal polyp
ICD-10 code
J33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
The recurrence of sinonasal polyps
Timepoint
1 and 3 and 6 months after the intervention
Method of measurement
By endoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Sinonasal polyps surgery by functional endoscopic plus nasal Fluticasone spray one puff every 12 hours, tablet Cefixime 400 mg once daily, tablet Loratadine 10 mg every 12 hours, and nasal irrigation three times daily for 2 weeks as well as Helicobacter pylori treatment with four-drug regimen including capsule Amoxicillin 1 g every 12 hours, tablet metronidazole 500 mg every 12 hours, tablet bismuth 420 mg every 12 hours, and tablet Pantoprazole 40 mg every 12 hours for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Sinonasal polyps surgery by functional endoscopic plus nasal Fluticasone spray one puff every 12 hours, tablet Cefixime 400 mg once daily, tablet Loratadine 10 mg every 12 hours, and nasal irrigation three times daily for 2 weeks as well as tablet placebo every 12 hours for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr. Aram Toolabi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Toolabi_a@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Aram Toolabi
Position
Resident of ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Toolabi_a@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Javaneh Jahanshahi
Position
ENT Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Jahanshahi287@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available