Evaluation of blind anal fistula treatment (BAFT) for anal fistula treatment
Design
Randomized clinical trial with control group, randomized (six-block), single-blind, with parallel groups and phase 2-3
Settings and conduct
In this randomized clinical trial study, 50 patients will be divided into two groups and after division, the relevant surgical procedure will be performed for them; For the intervention group, surgery will be performed by BAFT method and the control group will perform surgery by routine method and finally their recovery will be compared. The person analyzing the results will be unaware of the grouping of patients and will remain blind during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria are candidates for pre-anal fistula surgery and Exclusion criteria: History of diabetes, patients with coagulation problems and patients with inflammatory bowel disease.
Intervention groups
This study will be a randomized, single-blind clinical trial in Imam Reza Hospital (Tabriz University of Medical Sciences) with the participation of 50 patients. Patients will be randomly divided into two groups, the surgical intervention group will perform BAFT method and the control group will perform routine surgery. Finally, patients' pain and recovery status will be assessed.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N29
Registration date:2022-04-28, 1401/02/08
Registration timing:prospective
Last update:2022-04-28, 1401/02/08
Update count:0
Registration date
2022-04-28, 1401/02/08
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of blind anal fistula treatment (BAFT) for anal fistula treatment
Public title
Blind anal fistula treatment (BAFT) for anal fistula treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for preanal fistula surgery
Exclusion criteria:
History of diabetes
Patients with coagulation problems
Patients with inflammatory bowel disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block random division method (4 blocks) is used. One of the study partners, for whom blindness has not been performed, names the treatment with the letters A and B. The researcher then distributes packages A and B among the patients referred to participate in the study by block random division method (4). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. How to create a random sequence using randomization was simple. To make a random sequence, we give possible blocks (6 blocks) from one to 6 numbers. Depending on the sample size, any number of 4 blocks that are needed will be used. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyzer will be unaware of the grouping of patients and will only analyze the data; Therefore, the person analyzing the results will be blind during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.TBZMED.REC.1400.1151
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Anal fistula healing
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: A total of 25 patients will be included in this group after random allocation. Patients will be hospitalized and then transferred to the operating room. The BAFT method will then be used for their surgery. Before surgery and two weeks after surgery, the severity of pain and the extent of anal fistula healing in patients will be evaluated.
Category
Treatment - Surgery
2
Description
Control group: A total of 25 patients will be included in this group after random allocation. Patients will be hospitalized and then transferred to the operating room. Then the routine method of anal fistula surgery will be used for their surgery. Before surgery and two weeks after surgery, the severity of pain and the extent of anal fistula healing in patients will be evaluated.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ramin Azhogh
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Shahabi_p@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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