ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000254796

Ethics application status

Approved

Date submitted

28/02/2013

Date registered

4/03/2013

Date last updated

4/03/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

Botulinum toxin versus botulinum toxin with low dose Glyceryltrinitrite (GTN) cream for healing of chronic anal fissure: prospective, randomised trial

Scientific title

Botulinum toxin versus botulinum toxin with low dose Glyceryltrinitrite (GTN) cream for healing of chronic anal fissure: prospective, randomised trial

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic anal fissure

Condition category

Condition code

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-A injection 20 units in total, 10 units intramuscular to each side of internal anal sphincter at 3 and 9 o`clock position and 1cm of 0.2% GTN cream applied topically to anal fissure area for 6 weeks thrice daily.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Botox-A injection 20 units to Internal anal sphincter

Control group

Active

Outcomes

Primary outcome [1]

Healing of anal fissure by direct visualization of fissure area using anal fissure grades.

Timepoint [1]

12 weeks

Secondary outcome [1]

Head aches with GTN by using numeric pain scale with range from 0-10.

Timepoint [1]

6 weeks.

Eligibility

Key inclusion criteria

All patients with chronic anal fissure(CAF) from the Waikato region of New Zealand, with ages ranging from 18-80 years.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

previous surgical treatment for anal fissure, pregnancy (current or planned) & lactation, inflammatory bowel disease, rectal or anal malignancy, unable to self administer medications, unable to complete necessary trial documentation or unable to attend necessary clinical follow up, any history of unexplained syncope or orthostatic hypotension, history of faecal incontinence, tuberculosis, HIV/AIDS, syphilis, peri-anal sepsis or fistulas, immunosuppressant and use of Viagra or other nitrate preparations for IHD

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)

Patients presenting after referral from GP to Anal fissure clinic in Waikato Hospital were assessed for their suitability for trial and then informed consent was obtained. Patients were allocated to group A (control) to receive 20 units of Botox injection only to internal anal sphincter and group B (exposure) to recieve 20 units of Botox injection and were prescribed with 0.2% GTN cream to apply 1cm of cream with glove to fissure area for 6 weeks.
Randomisation codes were generated by computer with study number from 1-50 before study started and patients were recruited to trial as they come in serial manner. There was no concealment in this study by means of third person.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised sequence generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Logistic regression for headache or not as the outcome and headache scores at baseline and group as explanatory variables.
Generalised linear mixed model to compare fissure pain score in two groups.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/03/2010

Actual

26/03/2010

Date of last participant enrolment

Anticipated

16/09/2011

Actual

16/09/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Waikato District Health Board

Address

Waikato Hospital, Pembroke street, Hamilton, Waikato 3204.
New Zealand.

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern-Y Regional Ethics Committee

Ethics committee address [1]

3rd Floor BNZ building, 354 Victoria street, Hamilton. 3204

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/09/2009

Approval date [1]

27/11/2009

Ethics approval number [1]

NTY/09/04/032

Summary

Brief summary

Anal fissure is one of the most common benign anorectal conditions, which may result from high internal anal sphincter (IAS) pressure. The goals of therapy are to break the cycle of sphincter spasm and tearing of anal mucosa, and to promote healing of fissure. Medical therapy is successful in the majority of patients with surgery reserved for refractory cases. Acute anal fissure usually heals spontaneously or with conservative treatment within six weeks, whereas chronic anal fissure is more intractable and is unlikely to heal with conventional conservative management.

Surgery by means of lateral internal sphincterotomy (LIS) carries the risk of permanent faecal incontinence. The risk has varied among reports from as low as 0 to as high as 24 percent. In Vitro and in vivo studies in animals have established that nitric oxide (NO) is probably the most important inhibitory neurotransmitter in IAS. Glyceryl trinitrite cream applied locally to the anus has been shown to cause lowering of IAS pressure in healthy subjects and to promote healing of anal fissures. Another non surgical agent for treatment for anal fissure is botulinum toxin (BT) which decreases the anal pressure by preventing release of acetylcholine from presynaptic nerve terminals. Maria et al reported a 73% healing rate for anal fissure after BT injection alone.

There is only one study previously, by Lysy et al., looking at the synergistic effect of BT and topical nitrates (isosorbide dinitrate) for healing of anal fissure, which showed significantly higher healing, 66%, in the combined treatment group compared to BT alone, 20%. Scholefield et al. conducted a dose finding study with different strengths of GTN for chronic anal fissure and found that 0.1% GTN cream has a higher healing rate compared to 0.2% cream, with a smaller percentage of patients reporting headaches: 18% versus 36% with 0.2% GTN cream.

The aims of the present study were to assess the efficacy, safety and patient compliance related to BT injection and combined treatment with BT injection and lowered dose 0.2% Glycerlytrinitite (GTN) cream for the treatment of CAF. We hypothesised that combined treatment would have a synergistic effect on healing and lowered dose GTN would help with patient compliance as GTN application is associated with severe headaches in some patients.

Trial website

none

Trial related presentations / publications

none

Public notes

none

Contacts

Principal investigator

Name

Dr Muhammad Asim

Address

Department of colorectal surgery, Waikato Hospital, Pembroke street, Hamilton. 3204

Country

New Zealand

Phone

+64211448889

Fax

aasim166@yahoo.com

Contact person for public queries

Name

Muhammad Asim

Address

Department of colorectal surgery, Waikato Hospital, Pembroke street, Hamilton. 3204

Country

New Zealand

Phone

+64211448889

Fax

aasim166@yahoo.com

Contact person for scientific queries

Name

Simione Lolohea

Address

Colorectal surgeon, Department of Colorectal Surgery, Waikato Hospital, Hamilton. 3204

Country

New Zealand

Phone

+64274822382

Fax

similolohea@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Botulinum toxin versus botulinum toxin with low-dose glyceryltrinitrate for healing of chronic anal fissure: A prospective, randomised trial.	2014

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically