Comparison of fistulectomy surgery with sphincterolasty in the treatment of anal fistula
Design
In order to randomly allocate the samples to two groups, a simple random method will be used, which is determined by the qualified patient's referral based on the entry and exit criteria, and by using a table of random numbers and selecting even or odd numbers for the allocation of the patient to the relevant group. The study is blinded from the point of view of the patients and the evaluator, and the patient and the evaluator are not aware of the possible outcomes and complications after the operation, but the surgeon is.
Settings and conduct
The intended study will be a single-blind randomized clinical trial on patients referred to Imam Khomeini Hospital in Sari during the years 1401-1402.
Participants/Inclusion and exclusion criteria
1.Patients with anal fistula referred to Imam Hospital in the age range of 15-80 years
2.Consent to participate in the study
Intervention groups
Patients with anal fistula referred to Imam Hospital in the age range of 15-80 years
Main outcome variables
Gas and stool incontinence
Recurrence rate
Duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221211056784N1
Registration date:2022-12-26, 1401/10/05
Registration timing:registered_while_recruiting
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Akram Kalani sarokolaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4204 1154
Email address
akram.kalani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-12, 1401/09/21
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation clinical consequence of fistulectomy with or with out immediate sphincteroplasty in the treatment of anal fistula
Public title
Fistulectomy with or with out primery repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with anal fistula in 15_80 age
Exclusion criteria:
Pregnancy
History of anal surgery
Coagulation disorder
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
By calculating the sample size, taking into account a certain number of patients, they will be divided into two equal groups, the number of measurement times is 4 times.
The sample collection is based on the goal and based on the entry and exit criteria.
In order to randomly allocate the samples to two groups, a simple random method will be used, which is determined by the qualified patient's referral based on the entry and exit criteria, and by using a table of random numbers and selecting even or odd numbers for the allocation of the patient to the relevant group. The study is blinded from the point of view of the patients and the evaluator, and the patient and the evaluator are not aware of the possible outcomes and complications after the operation, but the surgeon knows.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to randomly allocate the samples to two groups, a simple random method will be used, which is determined by the qualified patient's referral based on the entry and exit criteria, and by using a table of random numbers and selecting even or odd numbers for the allocation of the patient to the relevant group. The study is blinded from the point of view of the patients and the evaluator, and the patient and the evaluator are not aware of the possible outcomes and complications after the operation, but the surgeon is.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sari University of Medical Sciences
Street address
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
City
Sari
Province
Mazandaran
Postal code
4764647343
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1401.002
Health conditions studied
1
Description of health condition studied
Anal fistula
ICD-10 code
K60.3
ICD-10 code description
Anal fistula
Primary outcomes
1
Description
Recurrence rate
Timepoint
One week, two weeks, 1, 3, 6 and 12 months after the surgery, the patients are re-examined and they are studied in recurrence rate
Method of measurement
through a questionnaire
2
Description
Gas and stool incontinence
Timepoint
One week, two weeks, 1, 3, 6 and 12 months after the surgery
Method of measurement
through a questionnaire
3
Description
Postoperative satisfaction rate
Timepoint
One week, two weeks, 1, 3, 6 and 12 months after the surgery
Method of measurement
through a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: primary sphincteroplasty after fistulectomy in this group after fistulectomy is performed simultaneously in the same primary tissue repair operation with thread. And the results of this type of tissue repair, including the rate of recurrence and incontinence, are compared with the control group
Category
Treatment - Surgery
2
Description
Control group: fistulectomy without sphincteroplasty. In this group, after sphincterotomy, the tissue defect is repaired in a secondary way and over time, and there is no intervention after sphincterotomy for repair.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
akram kalani
Street address
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
City
Sari
Province
Mazandaran
Postal code
۴۷۳۴۳۴۷۶۴۶
Phone
+98 11 4204 1154
Email
neda_kalani22@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran university of medical science
Full name of responsible person
Dr. Pedram Ebrahim Nehad
Street address
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
City
Sari
Province
Mazandaran
Postal code
4734347646
Phone
+98 11 4204 1154
Email
neda_kalani22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran university of medical science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Akram kalani
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
City
Ghaemshahr
Province
Mazandaran
Postal code
۴۷۳۴۳۴۷۶۴۶
Phone
+98 11 4204 1154
Email
neda_kalani22@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akram kalani
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
City
Sari
Province
Mazandaran
Postal code
۴۷۳۴۳۴۷۶۴۶
Phone
+98 11 4204 1154
Email
neda_kalani22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akram kalani
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam khomeini hospital., Amir mazandarani Ave .,Sari., Iran
City
Sari
Province
Mazandaran
Postal code
۴۷۳۴۳۴۷۶۴۶
Phone
+98 11 4204 1154
Email
neda_kalani22@yahoo.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