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Trial registered on ANZCTR


Registration number
ACTRN12611001167954
Ethics application status
Approved
Date submitted
19/10/2011
Date registered
8/11/2011
Date last updated
8/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial comparing anal fistula closure rates between anal fistula plug insertion and ligation of intersphincteric fistula tract in patients with complex anal fistula of cryptoglandular origin
Scientific title
Randomised controlled trial comparing anal fistula closure rates between anal fistula plug insertion and ligation of intersphincteric fistula tract in patients with complex anal fistula of cryptoglandular origin
Secondary ID [1] 273242 0
Nil
Universal Trial Number (UTN)
U1111-1124-9640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex anal fistula 279003 0
Condition category
Condition code
Surgery 279186 279186 0 0
Surgical techniques
Oral and Gastrointestinal 279207 279207 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
Ligation of intersphincteric fistula tract (LIFT):
A pre-operative questionnaire assessing symptoms of incontinence will be completed after recruitment into the study. Following a sodium phosphate enema given one hour pre-operatively, the LIFT procedure is performed in the lithotomy or prone position under general anaesthesia with intravenous administration of 500mg metronidazole for antibiotic prophylaxis. Preparation of the operative site with Betadine and draping is performed in the standard manner. The internal opening is visualised with an anal retractor by the injection of water or hydrogen peroxide solution via the external opening. The fistula tract is cannulated with a Lockhart-Mummery fistula probe, the seton removed and an incision made adjacent to the intersphincteric groove. The intersphincteric plane is entered with the diathermy blade and artery forceps. The external and internal anal sphincter muscles are retracted apart and the fistula tract is encircled in the intersphincteric plane. The fistula probe is removed and the tract is suture ligated with 2/0 polyglactin on both the internal sphincter side and external sphincter side and is subsequently divided. Confirmation of division and secure ligation is made by further injection of saline or peroxide via the external opening of the fistula tract. Limited excision of the external opening is then performed and is left open. The intersphincteric incision is closed with interrupted 3/0 polyglactin sutures. The approximate duration of the procedure will be 60 to 90 minutes. Oral ciprofloxacin 250mg twice daily and metronidazole 200mg every 8 hours are prescribed for 2 weeks
Intervention code [1] 269576 0
Treatment: Surgery
Comparator / control treatment
Anal fistula plug (AFP) insertion:
The AFP group will have the same pre-operative and intra-operative preparations. After confirmation of the internal opening as described above, the fistula tract is gently curetted and cannulated. The AFP is then inserted snugly, trimmed so that there is no plug material protruding and then secured to the internal sphincter with 2/0 vicryl sutures. The mucosa adjacent to the internal opening will then be closed over the top of the end of the AFP. The AFP is trimmed so that the plug does not protrude via the external opening, which is also left open. The approximate duration of the procedure will be 60 to 90 minutes. Oral ciprofloxacin and metronidazole are prescribed for 2 weeks as described previously.
Control group
Active

Outcomes
Primary outcome [1] 279821 0
Fistula healing rate will be assessed clinically in outpatient setting from the absence of symptoms of pain & discharge from the fistula tract or surgical wounds. Endoanal ultrasonography or MRI will not be performed as granulation tissue is present in both healing and recurring fistulas and thus have similar appearances on both imaging modalities.
Timepoint [1] 279821 0
6, 12, 26 and 52 weeks after intervention
Secondary outcome [1] 294513 0
Continence as assessed using the Cleveland Clinic Florida Fecal Incontinence Score
Timepoint [1] 294513 0
6, 12, 26 and 52 weeks after intervention

Eligibility
Key inclusion criteria
Patients with complex transphincteric anal fistula of cryptoglandular origin determined by examination under anaesthesia and endoanal ultrasography will be eligible for the study following the insertion of a seton into the fistula tract for a minimum of 6 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Active anorectal or perianal sepsis
2) Anovaginal or rectovaginal fistulas
3) Ileo-anal pouch vaginal fistulas
4) Allergy or intolerance to porcine products
5) Ulcerative colitis or Crohn’s disease
6) Previous anal fistula plug, LIFT procedure, fistulotomy, lateral anal sphincterotomy and anal sphincter repair
7) Pregnancy at recruitment or parturition during study follow-up period
8) Patients deemed unable to give informed consent on clinical grounds

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270068 0
Hospital
Name [1] 270068 0
Concord Repatriation General Hospital
Country [1] 270068 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Hospital Rd
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 269034 0
None
Name [1] 269034 0
Address [1] 269034 0
Country [1] 269034 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272024 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 272024 0
Concord Repatriation General Hospital
Hospital Rd
Concord
NSW 2139
Ethics committee country [1] 272024 0
Australia
Date submitted for ethics approval [1] 272024 0
Approval date [1] 272024 0
01/09/2011
Ethics approval number [1] 272024 0
HREC/11/CRGH/135

Summary
Brief summary
Multiple surgical techniques have been described in the surgical literature for the treatment of high anal fistulas.
High anal fistulas include a large proportion of the anal sphincter muscles and therefore, laying open these fistula
tracts (which is the most effective way to treat a fistula) is not an option due to the high likelihood of faecal
incontinence. The anal fistula plug is a technique used to induce fistula tract healing and closure by plugging the
internal opening. This has gained popularity in the past 5 years. The Concord Hospital Colorectal Unit published the
outcomes from anal fistula plugs in 2010 and reported a success rate of 35%.

A new technique called Ligation of the Intersphincteric Fistula Tract or 'LIFT' was described in 2007 for treating high
anal fistulas. This also aims to disrupt the fistula tract but does so by tying off the tract close to its internal opening
without injury to the surrounding anal sphincter muscle mechanism. Success rates of this technique in published
case series range between 54 to 94%, although followup
and definitions of successful fistula closure varies
between studies. Both techniques are simple procedures that involve no muscle division.

The aim of this project is to assess and evaluate the rates of successful fistula closure comparing the two
techniques of the anal fistula plug versus the 'LIFT' procedure. To allow effective comparison between techniques, we are conducting a randomised trial on patients with high anal fistulas at Concord Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33225 0
Address 33225 0
Country 33225 0
Phone 33225 0
Fax 33225 0
Email 33225 0
Contact person for public queries
Name 16472 0
Dr Kelvin Kwok
Address 16472 0
Concord Repatriation General Hospital
Department of Colorectal Surgery
Hospital Rd
Concord
NSW 2139
Country 16472 0
Australia
Phone 16472 0
+61 2 9767 5000
Fax 16472 0
Email 16472 0
Kelvin.Kwok@sswahs.nsw.gov.au
Contact person for scientific queries
Name 7400 0
Dr Kelvin Kwok
Address 7400 0
Concord Repatriation General Hospital
Department of Colorectal Surgery
Hospital Rd
Concord
NSW 2139
Country 7400 0
Australia
Phone 7400 0
+61 2 9767 5000
Fax 7400 0
Email 7400 0
Kelvin.Kwok@sswahs.nsw.gov.au

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

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