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Trial registered on ANZCTR

Registration number

ACTRN12616001258448

Ethics application status

Approved

Date submitted

26/07/2016

Date registered

8/09/2016

Date last updated

31/10/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Randomised controlled trial comparing cutting seton vs ligation of intersphincteric fistula tract (LIFT) for complex anal fistula

Scientific title

Randomised control trial comparing clinical outcome of adult patients with anal fistulae treated with cutting seton or LIFT procedure

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Anal fistulae

Condition category

Condition code

Surgery

Surgical techniques

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

Intervention : Cutting seton
Cutting seton will be placed through the fistula track with the aid of Lockhart-Mummery. The anoderm overlying the sphincter complex will be scored with diathermy and the vessel loop secured snugly with suture ties. This duration of this procedure is approximately 45 minutes and will be performed by consultant colorectal surgeon. Patients will be reviewed every 6 weeks, and readmitted for tightening of the seton at a minimum of 6 weekly intervals until completion of treatment.
Completion of treatment is when the seton has cut through the sphincter . This decision is made by the treating Surgeon.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Comparator treatment: LIFT procedure
An incision is performed in the intersphincteric groove. The primary fistula tract is dissected out and isolated. The track is ligated and where possible, a section excised for histopathology. Where possible, the external track lateral to the sphincter complex is either excised or curetted. The duration of this procedure is approximateley 45 minutes and will be performed by consultant colorectal surgeon.

Control group

Active

Outcomes

Primary outcome [1]

Primary healing rate: defined as complete healing of the fistula track and external opening.

Timepoint [1]

12 weeks post surgery

Secondary outcome [1]

Secondary healing rate: defined as healing after second line therapy.

Timepoint [1]

12 months post second line therapy

Secondary outcome [2]

Recurrence: defined as any new onset of symptoms and an external fistula opening after documented complete healing identified by consultant colorectal surgeon.

Timepoint [2]

6 months and 12 months post therapy

Secondary outcome [3]

Continence: this will be assessed using the St Mark’s continence severity score.

Timepoint [3]

6weeks, 12weeks, 18weeks, 6 months and 12 months post therapy

Secondary outcome [4]

Anorectal physiology measures: anal manometry measured by stationery water perfused catheter. Endoanal ultrasound using B&K 3000 3d rotating anal transducer.

Timepoint [4]

pre operatively and 12 weeks post healing

Secondary outcome [5]

Time to primary healing: defined as complete healing of the fistula track and external opening.

Timepoint [5]

6 weeks, 12 weeks, 18 weeks, 6 months, 12 months post operative

Secondary outcome [6]

Pain as measured on a visual analogue scale.

Timepoint [6]

6 weeks, 12 weeks, 18 weeks 6 months and 12 months postoperative

Secondary outcome [7]

Stoma requirement as a result of treatment failure. This will be assessed by review of medical records.

Timepoint [7]

12 months post operative

Secondary outcome [8]

Patient satisfaction measured on a visual analogue scale

Timepoint [8]

6weeks, 12 weeks, 18weeks, 6 months and 12 months.

Secondary outcome [9]

Patient quality of life measured by questionnaire SF -12

Timepoint [9]

Preoperatively and 12 months.

Eligibility

Key inclusion criteria

Adult patients aged 18-80 years with complex anal fistula. Complex fistulae are defined as high trans-sphincteric or supra-sphincteric fistulae, anteriorly situated fistulae in women, fistula disease in the presence of impaired continence, and any recurrent fistula.
Current loose seton in situ for drainage of sepsis
Able to give valid consent
Deemed suitable for either LIFT or cutting seton procedure by treating surgeon

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Current active inflammatory bowel disease or known history of inflammatory bowel disease.
Fistulae not of cryptoglandular aetiology (e.g. radiation, foreign body, iatrogenic)
Multiple medical co-morbidities
Deemed unsuitable by the treating surgeon for either cutting seton or LIFT procedure

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)

There will be no allocation concealment.

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

The randomisation will be computer generated. Entrance into the randomisation will be preceded by stratification according to gender ( male or female) and previous anal fistula (yes or no).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Consecutive patients will be allocated to either LIFT or cutting seton by computer generated randomisation. Prior to randomisation, participants will be stratified according to gender and previous fistula procedures yes or no. Randomisation will be administered by an independent person.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Primary analysis will be at 3 months and longitudinal analysis will be 6 and 12 months and take into account secondary outcomes and correlated to patients. Repeated measures will be analysed using ANOVA with mixed modeling principles. Effects ( fixed and random) will be specified and estimated to identify which mechanisms and the degree to which they affected outcomes.
Descriptive analysis will be used to calculate mean, median and report 95% confidence intervals. Differences in continuous normally distributed data will be calculated using a t test. Differences in categorical variable will be calculated using Mann Whitney U test and Wilcoxin sign ranks test. Multivariate and univariate analysis will be performed and significance will be set at 0.05.
From current literature, the median rate of primary healing is 71% and 98.5% for LIFT and cutting seton, respectively. Using Pocock’s formula comparing two proportions in a randomised clinical trial with a difference of 20%, significance of 0.05 and rate of 30%, the number of patients in each group is determined to be 93. Allowing for dropouts, the total number to be recruited into the study will be 200 patients.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

30/09/2016

Actual

Date of last participant enrolment

Anticipated

30/12/2021

Actual

Date of last data collection

Anticipated

29/07/2022

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Hospital - Kogarah

Recruitment hospital [2]

Prince of Wales Private Hospital - Randwick

Recruitment postcode(s) [1]

2217 - Kogarah

Recruitment postcode(s) [2]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St George Hospital

Address [1]

Gray Street
KOGARAH NSW 2217

Country [1]

Australia

Primary sponsor type

Hospital

Name

St George Hospital Colorectal research fund

Address

Pelvic Floor Unit
Gray Street
Kogarah NSW 2217

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SESLHD Human Research Ethics Committee

Ethics committee address [1]

South Eastern Sydney Local Health District
Prince of Wales Hospital
G71 East Wing, Edmund Blacket Building
Cnr High & Avoca Streets
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/09/2015

Approval date [1]

26/07/2016

Ethics approval number [1]

15/2389HREC/15/POWH/446

Summary

Brief summary

Anal fistula is a common condition. The aims of treatment are fistula healing, prevention of recurrence and maintenance of continence.  Treatment options and their associated risks vary according to the fistula track.  Simple fistulae (intersphincteric or low trans-sphincteric) may be treated successfully with fistulotomy.  Complex fistulae pose a therapeutic challenge and carry a higher risk of treatment failure, altered continence and recurrence. (Joy and Williams 2002) (van okelen, Gosselink et al. 2013) To date, no single intervention simultaneously fulfils all three therapeutic aims.   

The cutting seton has been employed for centuries and involves the use of various materials (including suture, vessel loops etc) to slowly divide through the sphincter and induce fibrosis.  The literature reports recurrence rates in the 3 – 5 % range (Vial, Pares et al. 2010) .  Reported incontinence rates after cutting seton vary widely from 0 - 63 % (Vial, Pares et al. 2010) (Garcia-Aguilar, Belmonte et al. 1998) (Karri-Pekka, Hamalainen et al. 1997) (Charua-Guindic, Mendez-Moran et al. 2007) (Ritchie, Sackier et al. 2008) , which may be partially attributable to incomplete/inadequate scarring behind the seton when tightened rapidly. 

The ligation of the intersphincteric track (LIFT) procedure was described in 2007 as a sphincter preserving technique for high fistulae. (Rojanasakul, Pattanaarun et al. 2007) Early reports published fistula cure and continence rates in excess of 90% (ref).  Subsequent series have reported success rates ranging from 57% to 82%. (Yassin, Hammond et al. 2013)   The procedure involves identification, dissection and then ligation of the fistula track in the intersphincteric space, thereby eliminating the fistula source from its track and avoiding the need for sphincter division.

Multiple interventions to manage fistulae have been described including sphincter preserving techniques such as fibrin plugs and tissue glue. (Ellis and Clark 2006) (Garg 2009) With the prospect of altered continence as a complication, heterogeneity of fistula anatomy, and the interplay with physiology, studies are limited in their ability to generalise findings and recommend treatments in the form of guidelines.

Aim
To prospectively assess the clinical outcomes of patients with complex fistulae treated by cutting seton and compare these to patients treated by LIFT.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kim Chi Phan Thien

Address

Sydney Colorectal Assc
37 Gloucester Rd
Hurstville NSW 2220

Country

Australia

Phone

+61 2 85661000

Fax

+61 2 91133546

kimchiphanthien@sydneycolorectal.com.au

Contact person for public queries

Name

Vicki Patton

Address

Pelvic Floor Unit
St George Hospital
Gray Street
KOGARAH NSW 2217

Country

Australia

Phone

+61 2 91132715

Fax

+61 2 9113 3546

vicki.patton@health.nsw.gov.au

Contact person for scientific queries

Name

Kim Chi Phan Thien

Address

Sydney Colorectal Assc
37 Gloucester Rd
Hurstville NSW 2220

Country

Australia

Phone

+61285661000

Fax

+61 2 9113 3546

kimchiphanthien@sydneycolorectal.com.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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Documents added automatically

No additional documents have been identified.

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