Comparison of internal sphincterotomy and medical treatment with Aloevera gel in chronic anal fissure
Design
Two arm parallel group randomised trial
Settings and conduct
In this clinical trail, 50 patients who will be scheduled for chronic anal fissure in Velayat hospital of Qazvin will be randomly divided in 2 equal 25 patient group. All patients will be notified about treatment conditions and consent form will be obtained. In group A, surgical and routine care is performed, and in group B, the Alveolar gel is used three times a day. All patients are examined within two, four and six weeks after treatment, and they are assessed for itching, pain, bleeding and wound healing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic fissure that require treatment. Exclusion criteria : patients with Diabetes; Crohn's disease; Ulcerative colitis; Cancer and Pregnancy.
Intervention groups
Treatment group with internal sphincterotomy and medical treatment group with Aloevera gel
Main outcome variables
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in itching of chronic anal fissure.
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in bleeding of chronic anal fissure.
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in the pain of chronic anal fissure.
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in wound healing of chronic anal fissure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043425N1
Registration date:2019-05-16, 1398/02/26
Registration timing:prospective
Last update:2019-05-16, 1398/02/26
Update count:0
Registration date
2019-05-16, 1398/02/26
Registrant information
Name
Davoud Karimzadeh Aghda
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
davoud.karim65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Internal Sphincterotomy and Medical Treatment with Aloevera Gel in Chronic Anal Fissure
Public title
Medical Treatment with Aloevera Gel in Chronic Anal Fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic fissure that require treatment.
Exclusion criteria:
Diabetes
Crohn's disease
Ulcerative colitis
Cancer
Pregnancy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with Win Pepi
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 Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Vice chancellor for research
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.QUMS.REC.1397.203
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
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in itching of chronic anal fissure
Timepoint
Two, four and six weeks after treatment
Method of measurement
The itching score is defined from 0 lack of itching up to 4 very severe itching.
2
Description
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in bleeding of chronic anal fissure
Timepoint
Two, four and six weeks after treatment
Method of measurement
Permanent bleeding after defication means high bleeding, bleeding occasionally during defication means middle bleeding and the presence of thin transparent blood without bleeding during defication means that the bleeding is low and the absence of bleeding, for at least 5 days, means no bleeding.
3
Description
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in the pain of chronic anal fissure
Timepoint
Two, four and six weeks after treatment
Method of measurement
The complete absence of pain means relief in pain and having any rate of pain means no relief in pain.
4
Description
Comparison of internal sphincterotomy and medical treatment with Aloevera gel in wound healing of chronic anal fissure
Timepoint
Two, four and six weeks after treatment
Method of measurement
Full recovery of wound means anoderm healing without scarring and inflammation, relative healing of the wound means reducing inflammation and swelling of the wound, lack of wound healing means remaining the wound or worsening as abscess or fistula.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Internal sphincterotomy. This method is an operation performed on the internal anal sphincter muscle. The procedure helps by lowering the resting pressure of the internal anal sphincter, which improves blood supply to the fissure and allows faster healing.
Category
Treatment - Surgery
2
Description
Intervention group: Medical treatment with Aloevera gel. Aloevera gel as much as a knuckle three times a day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Educational and Treatment Center
Full name of responsible person
Davoud Karimzade Aghda
Street address
Taavon Square, 22 Bahman Blvd, Minoodar
City
Qazvin
Province
Qazvin
Postal code
2709437422
Phone
+98 28 3379 0620
Email
info@qums.ac.ir
Web page address
https://www.qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3367 5880
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Davoud Karimzadeh Aghda
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
davoud.karim65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Farahaninik
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taavon Sqare, 22 Bahman Blvd, Minoodar, Velayat Educational and Treatment Center
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3379 0622
Email
dr.zfarahaninik@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Davoud Karimzadeh Aghda
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Taavon Sqare, 22 Bahman Blvd, Minoodar, Velayat Educational and Treatment Center
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3379 0622
Email
davoud.karim65@gmail.com
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