Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000432718
Ethics application status
Approved
Date submitted
1/02/2022
Date registered
17/03/2022
Date last updated
6/06/2023
Date data sharing statement initially provided
17/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Botox for the treatment of chronic anal fissure: A randomized controlled trial
Scientific title
Efficacy of Botox versus glyceryl trinitrate for the treatment of chronic anal fissure: A randomized controlled trial
Secondary ID [1] 305376 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1270-5022
Trial acronym
BOCHRAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Anal Fissure 323728 0
Condition category
Condition code
Surgery 321256 321256 0 0
Other surgery
Oral and Gastrointestinal 321486 321486 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Botox (Botolinum Toxin Type A)
A solution of Botulinum Toxin in 0.9% saline will be made in 50 Units/ml concentration. 0.4 ml of the prepared solution will be injected in the intersphincteric groove on either side of the midline anteriorly (total amount of Botulinum Toxin used per patient will be 40 Units). The injection would be performed with the patient either in left lateral position or knee-elbow position.
The treatment will be administered in single session by the principal investigators in operating room where patient monitoring is available.
Intervention code [1] 321786 0
Treatment: Drugs
Comparator / control treatment
Glyceryl Trinitrate 0.2% ointment
Patients will be asked to apply the ointment, approximately 3 to 5 ml, inside the anal canal using the tube applicator three times daily for eight weeks. Adherence to the treatment will be confirmed from the patient verbally.
Control group
Active

Outcomes
Primary outcome [1] 329037 0
Fissure healing characterized by re-epithelialization of the fissure base assessed by clinical examination by a general surgeon with more than 5 years experience in the field. The assessor will be blinded to the initial treatment.
Timepoint [1] 329037 0
8 weeks after commencement of treatment
Secondary outcome [1] 401247 0
Improvement in pain score on 0 to 10 visual analogue scale
Timepoint [1] 401247 0
8 weeks after commencement of treatment

Eligibility
Key inclusion criteria
All adult patients (Age greater than or equal to 18 years) with chronic anal fissure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to Botox
Coexistent other anal conditions like hemorrhoids, fistula in ano etc
Fissures not located posteriorly or anteriorly
Coexistent inflammatory bowel disease like ulcerative colitis, crohn's disease
History of cluster headaches or migraine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomly assigned to one of the two treatment arms according to computer generated lists. Randomization sequence will be generated by Trials Unit, Institute of Public Health and Social Sciences, Khyber Medical University (IPHSS KMU) Peshawar. The treatment options will be enclosed in opaque envelopes by a researcher not associated with the trial. The randomization code will not be available to the principal investigators before the enrollment of all the study sample.

Upon qualifying for enrollment and consenting to participate in the study, the patient will be asked to pick one envelope and the appropriate treatment revealed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Allocation Ratio: 1:1
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Age: Comparison of two groups will be done via independent T test
2. Gender: Chi square test will be used for comparison of two groups
3. Duration of fissure: Independent sample T test will be used
4. Fissure Healing: Being a dichotomous variable, Chi square test will be used
5. Pain score: Independent sample T test will be used for comparison of pain improvement (End point pain score - Baseline pain score) in both groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2023
Actual
Date of last participant enrolment
Anticipated
12/10/2023
Actual
Date of last data collection
Anticipated
12/12/2023
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 24143 0
Pakistan
State/province [1] 24143 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 309745 0
University
Name [1] 309745 0
Khyber Medical College
Country [1] 309745 0
Pakistan
Primary sponsor type
University
Name
Khyber Medical College
Address
Khyber Medical College
University of Peshawar Campus
Main University Road
Peshawar
Country
Pakistan
Secondary sponsor category [1] 311897 0
None
Name [1] 311897 0
Address [1] 311897 0
Country [1] 311897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309501 0
Institutional Research and Ethical Review Board
Ethics committee address [1] 309501 0
Department of Medical Education
Khyber Medical College
University of Peshawar Campus
Main University Road
Peshawar
Ethics committee country [1] 309501 0
Pakistan
Date submitted for ethics approval [1] 309501 0
06/10/2021
Approval date [1] 309501 0
14/03/2022
Ethics approval number [1] 309501 0
136/DME/KMC

Summary
Brief summary
Chronic anal fissure is a common condition. An acute tear at the anal verge, if fails to heal within six weeks, leads to chronicity; characterized by increased anal tone, epithelial breach and fibrosis at the base of the fissure. The aim of the treatment, therefore, is to reduce the anal tone and increase the blood supply for healing.
Traditionally the treatment has been surgical i.e. lateral internal sphincterotomy under anaesthesia. Apart from surgery, several pharmacological options, aimed at reducing anal tone, have also been used with variable success rates. Out of those Glyceryl Trinitrate (GTN), Diltiazem and Botulinum toxin (Botox) have been studied with successful outcomes.
The current research regarding comparison of GTN and Botox is limited, and the RCTs conducted so far have either short follow up duration or small sample sizes. Moreover no study has been conducted locally to compare the efficacy of the two drugs.
The hypothesis of the study is that Botox injection leads to healing of the fissure more effectively than GTN.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114374 0
Dr Nisar Ahmed
Address 114374 0
Department of Surgery
Khyber Medical College
Main University Road
Peshawar
Country 114374 0
Pakistan
Phone 114374 0
+923215113569
Fax 114374 0
Email 114374 0
nisar.ahmed@kmc.edu.pk
Contact person for public queries
Name 114375 0
Dr Nisar Ahmed
Address 114375 0
Department of Surgery
Khyber Medical College
Main University Road
Peshawar
Country 114375 0
Pakistan
Phone 114375 0
+923215113569
Fax 114375 0
Email 114375 0
nisar.ahmed@kmc.edu.pk
Contact person for scientific queries
Name 114376 0
Dr Nisar Ahmed
Address 114376 0
Department of Surgery
Khyber Medical College
Main University Road
Peshawar
Country 114376 0
Pakistan
Phone 114376 0
+923215113569
Fax 114376 0
Email 114376 0
nisar.ahmed@kmc.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
1. Baseline Assessments
2. Assessment of outcome variables
3. Adverse events if any
When will data be available (start and end dates)?
01 March 2022 till 28 February 2023
Available to whom?
1. Original Researchers
2. Institutional Research Board
3. Trial Registry
Available for what types of analyses?
1. Original Research
2. Meta analysis/ Systematic Review
How or where can data be obtained?
email the corresponding author
nisar.ahmed@kmc.edu.pk


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13371Study protocol  nisar.ahmed@kmc.edu.pk 382829-(Uploaded-01-02-2022-18-54-21)-Study-related document.docx
15418Ethical approval  nisar.ahmed@kmc.edu.pk 382829-(Uploaded-14-03-2022-22-36-11)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.