Evaluation of the efficacy of topical hydrocortisone in the treatment of rectal fissure in patients undergoing pharmacological treatment referred to Fatemi Hospital
Determining the effectiveness of topical hydrocortisone in the treatment of anal fissures in patients undergoing drug treatment referred to the clinic of Fatemi Hospital and Kosar Clinic of Ardabil Medical Sciences
Design
The sample size will be 200 people, which will be in two parallel groups of 100 people. There is no randomization in the study. Blindness has not been observed. The study is in the third phase of clinical trial.
Settings and conduct
The study will be conducted in the clinic of Fatemi Hospital and Kosar Clinic of Ardabil Medical Sciences. 200 patients will be included in the study. In the first group, routine treatment and in the second group, in addition to routine treatment, hydrocortisone ointment will be prescribed. Correction and randomization in the study have not been observed.
Participants/Inclusion and exclusion criteria
Including criteria:
Patients with chronic anal fissures
Age 15 to 40 years
Excluding criteria:
• Addiction to any drug
• History of pre-anal surgery
• Existence of simultaneous hemorrhoids
• Acute fissures
• Any Fisher's symptoms in diseases such as Crohn's or tuberculosis or malignancy
• People with Crohn's disease
• People with ulcerative colitis
• Patients with hypothyroidism
Intervention groups
Intervention Group 1: This group includes 100 patients with chronic Fisher's disease. For 3 months, these patients are treated with Diltiazem 2.% pea gel about half a gram every 8 hours, psyllium powder is dissolved in a glass of water and consumed every morning. Lactulose 5 cc syrup every 8 hours. 1% topical hydrocortisone topical ointment made by Abu Reihan Company will consume the size of a pea weighing approximately 0.35 grams every 8 hours. The second intervention group is exactly the same as the first intervention group, except that it will not be prescribed hydrocortisone.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191224045888N1
Registration date:2020-05-29, 1399/03/09
Registration timing:retrospective
Last update:2020-05-29, 1399/03/09
Update count:0
Registration date
2020-05-29, 1399/03/09
Registrant information
Name
Mir Salim Seyd Sadegi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
m.notash@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-08-21, 1398/05/30
Trial completion date
2019-08-21, 1398/05/30
Scientific title
Evaluation of the efficacy of topical hydrocortisone in the treatment of rectal fissure in patients undergoing pharmacological treatment referred to Fatemi Hospital
Public title
The effect of topical hydrocortisone in the treatment of anal fisher
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic Anal Fisher
Exclusion criteria:
Any drug addiction
Peri anal surgery history
Hemorrhoids at the same time
Acute Fisher
Patients with Crohn's disease
Patients with ulcerative colitis
Patients with hypothyroidism
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
No. 1,Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613874595
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.ARUMS.REC.1399.027
Health conditions studied
1
Description of health condition studied
Chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
Pain scale
Timepoint
On first visit, 2 weeks later, 6 weeks later, 3 months later
Method of measurement
NRS (numerical rating scale) questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1:This group includes 100 patients with chronic Fisher's disease. For 3 months, these patients are treated with Diltiazem 2.% made by sobhan company pea gel about half a gram every 8 hours, psyllium powder made by poorsina company is dissolved in a glass of water and consumed every morning. Lactulose 5 cc syrup made by emad darman pars every 8 hours. 1% topical hydrocortisone topical ointment made by Abu Reihan Company will consume the size of a pea weighing approximately 0.35 grams every 8 hours. The second intervention group is exactly the same as the first intervention group, except that it will not be prescribed hydrocortisone.
Category
Treatment - Drugs
2
Description
Intervention group 2: This group includes 100 patients with chronic Fisher's disease.This group is treated exactly with the drugs of the first group, except that they will not receive hydrocortisone.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Dr Mahdi Notash
Street address
No. 1, Emam khomeyni Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
m.notash@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh Naftchi
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
56138745852
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Mahdi Notash
Position
Resident General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 1, Emam khomeyni Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843789
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mahdi Notash
Position
Resident General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 1, Emam khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843789
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mahdi Notash
Position
Resident General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 1, Emam khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The questionnaires will be made available anonymously and with a file number.
When the data will become available and for how long
After completing the study
To whom data/document is available
University professors
Under which criteria data/document could be used
En In order to find out how to work in SPSS file, anonymous questionnaires will only be available with file number.
From where data/document is obtainable
Contact Dr. Mahdi Notash
What processes are involved for a request to access data/document
Information is available after contacting Dr. Mahdi Notash and University approval