Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000557538p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2024
Date registered
2/05/2024
Date last updated
2/05/2024
Date data sharing statement initially provided
2/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing healing outcomes for cutting seton and the ligation of intersphincteric tract (LIFT) procedure in adult patients with complex primary fistula-in-ano
Scientific title
Healing without faecal incontinence - a comparison of cutting seton versus ligation of intersphincteric fistula tract (LIFT) for complex cryptoglandular fistula-in-ano: a prospective, multi-center, randomized trial
Secondary ID [1] 311973 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fistula-in-ano 333581 0
Condition category
Condition code
Surgery 330262 330262 0 0
Surgical techniques
Oral and Gastrointestinal 330263 330263 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
Cutting seton versus LIFT
Comparison of two well-recognised surgical techniques for the management of fistula-in-ano. There is currently no procedure considered 'standard of care' in complex fistula management, but LIFT tends to be the preferred technique in many centres due to the very low reported risk of faecal incontinence.
Patients will be randomised into either intervention and be analysed on a per-protocol bases. The procedures will be performed by Colorectal Surgeons with a minimum of 3 years subspecialty experience. Failure to achieve healing will be addressed surgically (as per standard of care) but cross-over between groups will not be allowed. If the fistula is converted to a simpler anatomy post failure to heal, the surgical technique required to achieve healing will be documented. Education will be provided to treating surgeons to attempt to standardise the technique across sites.

Intervention:
Cutting setons involve slowly tightening a silastic tie or suture around the involved sphincter. Tightening will occur at 6 weekly intervals until healing is achieved. On average, cutting setons achieve complete healing with 2-3 tightenings with a median healing time of 15 weeks. Over time, fibrosis occurs and the seton becomes more superficial. This is ideal for high fistulas that involve too much muscle to consider fistulotomy (cutting the muscle). This procedure (both the initial exploration and subsequent tightenings) can be performed under general anaesthesia or sedation at the discretion of the treating team. The use of pre-operative enemas will also be at the discretion of the treating team and is not specifically recommended.
An educational, descriptive video will be made available describing the appropriate technique, and operative notes will be reviewed to ensure procedural standardisation is maintained.
Intervention code [1] 328434 0
Treatment: Surgery
Comparator / control treatment
The LIFT procedure is performed in lithotomy under general anaesthesia. This procedure can take up to an hour to perform depending on the surgeon and the anatomy of the tract.
The principle of the LIFT technique involves closure of the internal opening to prevent further soiling of the fistula tract from faecal particles entering, as well as eliminating any persistent nidus of infection within the intersphincteric space. This is achieved by identifying and isolating the fistula tract through an incision in the intersphincteric groove. Once isolated, the tract is suture-ligated and divided distally. The external opening and remnant tract is then opened and debrided up to the level of the sphincter-complex and the incisions loosely closed.
This procedure will be performed once, but should healing not be achieved, further intervention dependent on the residual tract will be performed. If an intersphincteric tract remains - further LIFT will be performed. Otherwise, fistulotomy or debridement may be performed and documented until healing achieved at the discretion of the treating surgeon.
Standardisation of the technique will be facilitated by education at included sites with reference to the original descriptive publication of technique recommended by Rojanasakul et al (2016)
Control group
Active

Outcomes
Primary outcome [1] 338009 0
Efficacy of healing
Timepoint [1] 338009 0
6 weeks, 12 weeks post primary/initial intervention
6 months following documented healing
6 months after primary healing is achieved is the primary end point
Secondary outcome [1] 434106 0
Faecal incontinence
Timepoint [1] 434106 0
6 weeks post initial intervention and 6 months following documented healing
Secondary outcome [2] 434347 0
Safety
Timepoint [2] 434347 0
Immediate post-operative complications (within 24 hours) and within the first 6 weeks post initial intervention (primary surgery)
Secondary outcome [3] 434348 0
Patient Satisfaction
Timepoint [3] 434348 0
6 weeks following initial intervention and 6 months post healing global question
Surgical Satisfaction Questionaire for 6 weeks following initial intervention and 6mths post healing
Secondary outcome [4] 434665 0
Pain
Timepoint [4] 434665 0
At 6 weeks post initial intervention and 6months post healing

Eligibility
Key inclusion criteria
• Adult patients (18 years and over) with complex cryptoglandular anal fistula requiring operative management
• Complex fistulae are defined as high trans- sphincteric or supra-sphincteric fistulas, anteriorly situated fistulas in women, fistula disease in the presence of impaired continence, and any recurrent fistulas
• Able to give valid consent
• Current loose seton in situ for control of perianal sepsis
• Deemed by treating surgeon based on imaging (endoanal ultrasound or MR) or examination under anaesthesia to be suitable for LIFT or cutting seton (based on anatomy of the tract)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Fistula anatomy or patient deemed unsuitable by the treating surgeon for either cutting seton or LIFT
• Inflammatory bowel disease – currently active or known history
• Secondary/non-cryptoglandular aetiology (ie. radiation, trauma, malignancy)
• Active immunosuppression (diabetes excepted)
• Patients defunctioned with a stoma

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)
Allocation concealed via central, computer-generated randomisation following determination of inclusion criteria being met to allocate groups
Treating team will contact the pelvic floor CN or PI to be advised of which group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via a computer-generated allocation. Within this randomisation there will be repeated blocks of 2, 4 and 6 patients
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316320 0
Hospital
Name [1] 316320 0
St George Hospital
Country [1] 316320 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Country
Australia
Secondary sponsor category [1] 318504 0
None
Name [1] 318504 0
Address [1] 318504 0
Country [1] 318504 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315132 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 315132 0
Ethics committee country [1] 315132 0
Australia
Date submitted for ethics approval [1] 315132 0
15/04/2024
Approval date [1] 315132 0
Ethics approval number [1] 315132 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133770 0
Dr Ashley Jenkin
Address 133770 0
St George Hospital, Gray St Kogarah, NSW 2217
Country 133770 0
Australia
Phone 133770 0
+61433335762
Fax 133770 0
Email 133770 0
[email protected]
Contact person for public queries
Name 133771 0
Ashley Jenkin
Address 133771 0
St George Hospital, Gray St Kogarah, NSW 2217
Country 133771 0
Australia
Phone 133771 0
+61291131111
Fax 133771 0
Email 133771 0
[email protected]
Contact person for scientific queries
Name 133772 0
Professor David Lubowski
Address 133772 0
St George Hospital, Gray St Kogarah, NSW 2217
Country 133772 0
Australia
Phone 133772 0
+61291131111
Fax 133772 0
Email 133772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification; individual participant data underlying published results
When will data be available (start and end dates)?
From time of publication up to 5 years thereafter
Available to whom?
researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of Primary/Senior Investigator
Available for what types of analyses?
To facilitate meta-analysis; unrestricted
How or where can data be obtained?
access subject to approvals by Principal Investigator and Senior Investigator at [email protected]


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
No additional documents have been identified.