ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

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]

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]

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]

8 weeks after commencement of treatment

Secondary outcome [1]

Improvement in pain score on 0 to 10 visual analogue scale

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Khyber Pakhtunkhwa

Funding & Sponsors

Funding source category [1]

University

Name [1]

Khyber Medical College

Address [1]

Khyber Medical College
University of Peshawar Campus
Main University Road
Peshawar

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Research and Ethical Review Board

Ethics committee address [1]

Department of Medical Education 
Khyber Medical College
University of Peshawar Campus
Main University Road
Peshawar

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

06/10/2021

Approval date [1]

14/03/2022

Ethics approval number [1]

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

Dr Nisar Ahmed

Address

Department of Surgery
Khyber Medical College
Main University Road
Peshawar

Country

Pakistan

Phone

+923215113569

Fax

nisar.ahmed@kmc.edu.pk

Contact person for public queries

Name

Nisar Ahmed

Address

Department of Surgery
Khyber Medical College
Main University Road
Peshawar

Country

Pakistan

Phone

+923215113569

Fax

nisar.ahmed@kmc.edu.pk

Contact person for scientific queries

Name

Nisar Ahmed

Address

Department of Surgery
Khyber Medical College
Main University Road
Peshawar

Country

Pakistan

Phone

+923215113569

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
13371	Study protocol			nisar.ahmed@kmc.edu.pk		382829-(Uploaded-01-02-2022-18-54-21)-Study-related document.docx
15418	Ethical 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.

Trial Review

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