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Comparative study of the effectiveness of two methods of drug therapy and band ligating in controlling bleeding and treatment in patients with hemorrhoids of grade 2 and 3

Protocol summary

Study aim
1. Determining the frequency distribution of hemorrhage in patients undergoing drug treatment, ten days after starting treatment 2. Determining the frequency distribution of the necessary turns of the ligation band to stop the bleeding 3. Determining the frequency distribution of the necessary turns of the ligation band to remove the hemorrhoid (eradication) 4. Comparison of the frequency distribution of hemorrhage in patients treated with ligation band and drug treatment 5. Comparison of frequency distribution of recurrence in one-year follow-up period in patients undergoing ligation and drug treatment
Design
Randomized, parallel group trial without blinding. Randomization was done with a randomization random numbers software.
Settings and conduct
The study is performed in the clinics of Khorshid and AlZahra hospitals. The control group receives drug treatment and the intervention group undergoes ligation. The drug treatment group is re-visited ten days after the start of treatment. The ligation band group is visited every month to a year and, if necessary, is re-ligated bandage until the hemorrhoid warts are completely removed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with grade 2 and3 hemorrhoids and rectal bleeding without other anorectal problems Exclusion criteria: 1. Conscious dissatisfaction 2. Coagulation problems 3. Immune deficiency 4. Cirrhosis of the liver 5. portal hypertension
Intervention groups
Sixty patients with a diagnosis of grade 2 or 3 internal hemorrhoids are randomly divided into two groups. Half of the patients are treated with antihemorrhoid ointment. The second group of patients are treated with ligation band method.
Main outcome variables
Type of treatment, independent, nominal; recurrence, dependent, nominal; bleeding, dependent, nominal; age, underlying, continuous; sex, underlying, nominal; response time, dependent, continuous

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210630051748N1
Registration date: 2021-07-13, 1400/04/22
Registration timing: prospective

Last update: 2021-07-13, 1400/04/22
Update count: 0
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
azam teimouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3071
Email address
a_teimouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-27, 1400/05/05
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of two methods of drug therapy and band ligating in controlling bleeding and treatment in patients with hemorrhoids of grade 2 and 3
Public title
Comparison of the effectiveness of drug treatment and elastic band therapy in the treatment of hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with grade 2 and 3 hemorrhoids and with anal bleeding who do not have another anorectal problem
Exclusion criteria:
concomitant external hemorrhoids coagulation disorder immunodeficiency liver cirrhosis taking anticoagulants drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of double blocks
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
Isfahan university of medical science ethical committee
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.MUI.MED.REC.1400.239

Health conditions studied

1

Description of health condition studied
Hemorrhoid
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis

Primary outcomes

1

Description
Recurrence of hemorrhoid after band ligation or medical treatment
Timepoint
Four weeks after intervention
Method of measurement
Physical examination

2

Description
Bleeding
Timepoint
Four weeks after intervention
Method of measurement
Measuring bleeding volume by cc

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Band ligation; The patients supposed to be treated with band ligation are required to lie in the knee chest or lateral position. First, the anus is lubricated with Lidocaine gel, and then the anoscope is inserted into the anus, and with a hemorrhoidectomy device connected to a suction tube, one or two elastic bands are used to ligate the band. Then, the patient is given the necessary explanations for not using suppositories and ointments during this period. The patient is then recommended to return for re-examination one month after hemorrhoidectomy and, if necessary, re-ligation. The patient then visits every month for complete removal of the hemorrhoid patches and one year after complete recovery the patient returns for re-evaluation to check for recurrence.
Category
Treatment - Other

2

Description
Control group: Medical treatment; These patients are treated with anti-hemorrhoid ointment. Patients are then told to see their doctor again after a month. These referrals are repeated every month for a year.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Alzahra Hospital
Full name of responsible person
Azam Teimouri
Street address
Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

2

Recruitment center
Name of recruitment center
Isfahan Khorshid Hospital
Full name of responsible person
Azam teimouri
Street address
Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
dean@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
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
Azam Teimouri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azam Teimouri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azam Teimouri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
a_teimouri@med.mui.ac.ir

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
Excel file of all variables without mentioning name and address
When the data will become available and for how long
From Farvardin1401 for one year
To whom data/document is available
Physicians and researchers
Under which criteria data/document could be used
In order to conduct more clinical studies and to treat patients better
From where data/document is obtainable
Dr. Azam Teimouri
What processes are involved for a request to access data/document
Sending an email to the project executor, receiving a response email and specifying the reason for the need for data, reviewing the request, sending the data
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