Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000605897
Ethics application status
Not yet submitted
Date submitted
5/06/2012
Date registered
6/06/2012
Date last updated
18/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Appraisal of the LIFT and BioLIFT procedure: initial experience and short-term outcomes of patients with complex anal fistula.
Scientific title
Appraisal of the LIFT and BioLIFT procedure: initial experience and short-term outcomes of patients with complex anal fistula.
Secondary ID [1] 280612 0
none
Universal Trial Number (UTN)
none
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
transphincteric anal fistula 286624 0
Condition category
Condition code
Surgery 286901 286901 0 0
Surgical techniques
Oral and Gastrointestinal 286927 286927 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The purpose of this study is to evaluate and compare outcomes of patients where repair of transphincteric anal
fistula was performed using LIFT and BioLIFT techniques.

This is a retrospective review of patient who had undergone the LIFT and BioLIFT procedure. Data will be collected from the hospital medical records. Followup details will be obtained from surgeon's private rooms.

The 'intervention' group would be patient who had the BioLIFT procedure for treatment of transphincteric anal fistula, from 2011 to current, by a single surgeon. The BioLIFT procedure involves the use of a bioprosthetic device to augment the LIFT (Ligation of Intersphincteric Fistula Tract) procedure.
Intervention code [1] 285007 0
Not applicable
Comparator / control treatment
The purpose of this study is to evaluate and compare outcomes of patients where repair of transphincteric anal
fistula was performed using LIFT and BioLIFT techniques.

This is a retrospective review of patient who had undergone the LIFT and BioLIFT procedure. Data will be collected from the hospital medical records. Followup details will be obtained from surgeon's private rooms.

The 'comparator' group would be patient who had the LIFT (Ligation of Intersphincteric Fistula Tract) procedure for treatment of transphincteric anal fistula, from 2011 to current, by a single surgeon.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287255 0
The purpose of this study is to evaluate and compare short-term outcomes of patients where repair of transphincteric anal fistula was performed using LIFT and BioLIFT techniques.

Outcomes measures of complications, recurrence, physiology studies performed pre and post operative will be evaluated using data collected from the hospital medical records and surgeon's files.
Timepoint [1] 287255 0
Patients who have undergone LIFT or BioLIFT procedure from 2011-current, by a single surgeon will be retrospectively reviewed.

Data collection will commence upon receipt of approval from the ethics committee. Once data collection is complete, the outcome measures will be assessed and evaluated.
Secondary outcome [1] 297758 0
Nil
Timepoint [1] 297758 0
Nil

Eligibility
Key inclusion criteria
Patients: Patients will be retrieved from a single surgeon logbook.

Inclusion criteria of patients analysed :
1. Patients with diagnosis of complex suprasphincteric anal fistula of cryptoglandular in origin
2. All patients, both male and female who are >18years of age with perianal sepsis
3. Crohn’s patients as a separate subset analysis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1.Patients < 18years of age
2.Defunctioning stomas
3.Patient with noncryptoglandular fistula, Tuberculosis and malignant fistulas

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285370 0
Self funded/Unfunded
Name [1] 285370 0
Colorectal Research, Royal Prince Alfred Hospital (RPAH)
Country [1] 285370 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Lee
Address
Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 284224 0
Individual
Name [1] 284224 0
Dr Min Hoe Chew
Address [1] 284224 0
Surgical Outcomes Research Centre, Royal Prince Alfred
Hospital, Building 89, Level 9 East
Missenden Road Camperdown NSW 2050
Country [1] 284224 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287385 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 287385 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 287385 0
Australia
Date submitted for ethics approval [1] 287385 0
22/05/2012
Approval date [1] 287385 0
Ethics approval number [1] 287385 0
LNR/12/RPAH/264 & X12-0163

Summary
Brief summary
The surgical management of anal fistulas remains in an evolutionary phase. A new sphinctersaving technique known as the LIFT (ligation of intersphincteric tract) procedure has gained growing interest. Early results together with reports from other authors have been promising with 57-94% success and minimal complications. The use of a bioprosthetic device has been suggested to augment the LIFT procedure (BioLIFT).

The purpose of this study is to evaluate and compare outcomes of patients where repair of transphincteric anal
fistula was performed using LIFT and BioLIFT techniques.

Patients who have undergone LIFT or BioLIFT procedure from 2011-current, by a single surgeon will be
retrospectively reviewed. Case notes will be retrieved and data entry performed. Statistical analysis of outcomes will
be assessed. Outcomes measures of complications, recurrence, physiology studies performed pre and post
operative, will be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34261 0
Address 34261 0
Country 34261 0
Phone 34261 0
Fax 34261 0
Email 34261 0
Contact person for public queries
Name 17508 0
Dr Peter Lee
Address 17508 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
Country 17508 0
Australia
Phone 17508 0
+61 2 9519 7576
Fax 17508 0
+61 2 9519 1806
Email 17508 0
[email protected]
Contact person for scientific queries
Name 8436 0
Dr Peter Lee
Address 8436 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
Country 8436 0
Australia
Phone 8436 0
+61 2 9519 7576
Fax 8436 0
+61 2 9519 1806
Email 8436 0
[email protected]

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
No additional documents have been identified.