Determining the effect of glycerin suppository administration in patients with chronic anal fissure referred to Alzahra Hospital clinic in 2021
Design
Clinical trial with control group, with parallel groups, single blinded, randomized, on 120 patients
Stratified randomization will be done through randomization software
Settings and conduct
Study is single-blind.Patients are randomly divided into 2groups of 60. treatment,in the controls is using a topical combination of lidocaine ointment and 2% diltiazem q8hr,and in the interventions is in the form of pediatric glycerin suppository(1gr)5 minutes after using lidocaine ointment and diltiazem every morning .The use of lidocaine and diltiazem ointment the same as the controls q8hr. Patients are visited 3 times and the information is recorded in a serial examination based on a checklist after treatment;Then visited again after three months.
Participants/Inclusion and exclusion criteria
Inclusion crteria:posterior or anterior fisher history of autoimmune disease,Immunity dificiency disease and previous gastrointestinal cancer,people over 40 years or positive family history of GI cancer with a normal colonoscopy؛no weight loss in the last 6 months and anorexia.With a positive FIT result or iron deficiency anemia,patient can be included in the study if colonoscopy and endoscopy are normal.Not entering :unwillingness to continue treatment؛smoking and spicy spices
Intervention groups
Treatment in the control:a topical combination of lidocaine ointment and diltiazem 2% q8hr.In the intervention:administration of pediatric glycerin suppository(1g) 5 minutes after using lidocaine ointment and diltiazem every morning, then the combination of lidocaine and diltiazem q8hr
Main outcome variables
Reduction of requiring surgery in patients with chronic anal fissure؛
Prevention of surgery complications including gas and stool incontinence and anal stenosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210717051915N1
Registration date:2021-07-31, 1400/05/09
Registration timing:prospective
Last update:2021-07-31, 1400/05/09
Update count:0
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Mohammad Eslamian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1995
Email address
nazi.raees@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Glycerin suppository application in patients with Chronic anal fissure
Public title
Evaluation of the effect of Glycerin suppository on anal fissure healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Posterior or anterior fissure No previous history of autoimmune disease No history of immunodeficiency disease No history of previous gastrointestinal cancer People over 40 years of age with normal colonoscopy No risk factor including weight loss during 6 Last month No anorexia No history of gastrointestinal genetic cancers (such as FAP, HNPCC) If a person is positive with FIT or a person with iron deficiency anemia, if he has a normal colonoscopy and endoscopy can be included in the study
Exclusion criteria:
Reluctance to continue treatment smoking and spicy spices
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligibility; After obtaining informed consent, are divided into two groups (control and intervention) through randomization software, and since we want the percentage of alcoholism to be the same in both groups, at the time of randomization, alcoholism is considered as a category. And we will use stratified randomization and finally 60 patients will be evaluated in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding is done and it is a single-blinded (the person who fills in the questionnaire
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Isfahan University of Medical Sciences
Street address
Deputy of Research and Technology- Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
Approval date
2021-07-16, 1400/04/25
Ethics committee reference number
IR.MUI.MED.REC.1400.315
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
1) Patients' pain score 2) Percentage of constipation improvement in the intervention group 3) Percentage of bleeding improvement in the intervention group 4) Percentage of improvement of incomplete stool discharge in the intervention group 5) Percentage of burning sensation in the intervention group 6) Percentage of itching improvement in the intervention group
Timepoint
1) Pain score of the intervention group with the control group before and after treatment (first day, second weekend, fourth weekend) 2) constipation of the intervention group and control group (first day, second weekend, fourth weekend) 3) bleeding Intervention group and control group (first day, second weekend, fourth weekend) 4) incomplete defecation of the intervention group and control group (first day, second weekend, fourth weekend) 5) burning of the intervention group and control group (first day , Second weekend, fourth weekend) 6) itching Intervention and control group (first day, second weekend, fourth weekend)
Method of measurement
1) Measuring pain through Visual Analogue Scale 2) Percentage of improvement of constipation through checklist 3) Percentage of improvement of bleeding through checklist 4) Percentage of improvement of incomplete stool discharge through checklist 5) Percentage of improvement of burning through checklist 6) Percentage of itching recovery through checklist
Secondary outcomes
1
Description
1) Headache improvement 2) Quality of life indicators score
Timepoint
1) Improvement of headache after treatment (second weekend, fourth weekend) 2) score of quality of life indicators before and after treatment (first day, second weekend, fourth weekend)
Method of measurement
1) Improvement of headache through a checklist 2) Score of quality of life indicators based on WHO-QOL 100 questionnaire
Intervention groups
1
Description
Intervention group: treatment is in the form of pediatric glycerin suppository 1 g, 5 minutes after using lidocaine ointment and diltiazem every morning, and the use of lidocaine and diltiazem ointment is the same as the control group every 8 hours during the day; Some lubricant gel can be impregnated around the suppository to facilitate passage. Iran Najo Pharmaceutical Co. Tehran-Iran
Category
Treatment - Drugs
2
Description
Control group: Treatment of fissure in this group is using a topical combination of lidocaine ointment and diltiazem 2% every 8 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Al-Zahra hospital clinic
Full name of responsible person
Mohammad Eslamian
Street address
Al-Zahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
nazi.raees@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Isfahan University of Medical Science
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Email
nazi.raees@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Eslamin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
mr.esl67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Eslamian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra University Hospita, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
mr.esl67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Eslamian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra University Hospital, Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
mr.esl67@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
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
Title and more details about the data/document
Information on the complications of the disease before treatment and changes after treatment can be shared.
When the data will become available and for how long
four months after the end of the clinical trial (February 2021)
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
According to the statistical analyzes, the data are evaluated and in case of positive results, this new treatment and intervention can be used as a new treatment and reduction of complications from previous treatments such as surgery in patients with chronic anal fissure.
From where data/document is obtainable
Dr. Mohammad Islamian - General Surgeon - Isfahan University of Medical Sciences- mr.esl67@gmail.com
What processes are involved for a request to access data/document
After the trial, the data are processed and reported within one to two months, depending on the type of variables and the type of statistical analysis, with the cooperation of a statistical consultant
Comments
The course of future releases will be announced in more detail