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Trial registered on ANZCTR
Registration number
ACTRN12610000669099
Ethics application status
Approved
Date submitted
30/06/2010
Date registered
16/08/2010
Date last updated
29/03/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot study on the safety and effectiveness of the Ligation of Intersphincteric Fistula Tract (LIFT) procedure as a treatment for fistula-in-ano.
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Scientific title
A pilot study on the safety and effectiveness of the Ligation of Intersphincteric Fistula Tract (LIFT) procedure as a treatment for fistula-in-ano.
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Secondary ID [1]
252071
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fistula-in-ano
257611
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Condition category
Condition code
Surgery
257788
257788
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All potential participants will be screened by their respective specialists at their rooms at the time of consultation. Information will be provided for patients who consent to participate in the study. Pre-operative assessment using manometry, endoanal ultrasound and pudendal nerve terminal motor latency will remain unchanged in accordance to our usual practice. Pre-operative assessment of continence will also be carried out using the St. Mark’s continence score as well as Cleveland Clinic continence score. As all pre-operative work up of the patient and pre-operative preparation including bowel prep and routine intravenous antibiotic use will remain the same, the only differences for participants of this study are: the type of surgery offered and post operative follow up. The LIFT procedure will be performed using the technique described by Rojanasakul and colleagues. The operation involves a small cut around the anus, identifying the fistula between the 2 anal sphincter muscles and division of this part of the fistula. Patients will be admitted to the hospital on the day of surgery unless otherwise indicated and it is expected that most patients will be discharged within 24-48 hours. On discharge, analgesia and aperients will be prescribed. Follow up will be carried out at 6 weeks, 3, 6 and 12 months post operatively. At each visit, clinical assessment of the fistula tract will be performed. Continence score, manometry and endoanal ultrasound will also be repeated at 3, 6 and 12 months post op to assess sphincter function and to confirm tract closure. In addition to pre-operative assessment and post operative follow up, demographic information, details about previous fistula and failed treatments, concurrent medical conditions will also be collected. Operative notes will also be reviewed to determine duration of operation and intra-operative technical difficulties or complications.
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Intervention code [1]
256698
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Treatment: Surgery
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Comparator / control treatment
N/A - This is a single group study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To assess the safety and feasibility of the LIFT procedure in an Australian setting at the Royal Prince Alfred hospital.
Intra-operative and post-operative complication data (if any) will be collected. Patients will be followed up post-operatively to determine their recovery progress from the surgery.
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Assessment method [1]
258657
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Timepoint [1]
258657
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Patients are assessed prior to surgery and they will also be followed-up at 6 weeks, 3, 6, 12 months post surgery.
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Secondary outcome [1]
264634
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To determine the cure rates of the LIFT procedure.
Patient will be assessed clinically as well as anorectal physiology including endoanal ultrasound.
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Assessment method [1]
264634
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Timepoint [1]
264634
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Patients are assessed prior to surgery and they will also be followed-up at 6 weeks, 3, 6, 12 months post surgery.
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Secondary outcome [2]
264635
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To assess risk of incontinence associated with the LIFT procedure.
Patient will be assessed clinically as well as anorectal physiology including endoanal ultrasound. Continence score will also be collected using St Marks Incontinence score and Cleaveland clinic feacal incontinence score.
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Assessment method [2]
264635
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Timepoint [2]
264635
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Patients are assessed prior to surgery and they will also be followed-up at 6 weeks, 3, 6, 12 months post surgery.
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Secondary outcome [3]
264636
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To determine the learning curve associated with the LIFT procedure.
This could be achieved by analysing the difficulties encountered during surgery and the length of surgical time (which are documented in the data collection form) for all patients recruited in the pilot study.
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Assessment method [3]
264636
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Timepoint [3]
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Starting from the recruitment of the first to the last participants who have undergone the LIFT procedure. It is anticipated that 20 patients will be recruited for this pilot study.
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Eligibility
Key inclusion criteria
i) Patients with cryptoglandular or Crohn's fistula
ii) Patients deemed inappropriate for fistulotomy or patients with complex fistulae, as defined by recurrent fistula, fistula involving > 30-50% of external sphincter, anterior fistula in a female patient and fistula in a patient with existing incontinence
iii) Ability to provide informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria are:
i) Patients with fistula related to pouch surgery
ii) Patients who are unable to provide informed consent to participation
iii) Patients who are unable to comply with follow up requirements
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All potential participants will be screened by their respective specialists at their rooms at the time of consultation. Information will be provided for patients who consent to participate in the study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
20/08/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
257165
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Self funded/Unfunded
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Name [1]
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Colorectal Research, Royal Prince Alfred Hospital (RPAH)
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Address [1]
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Colorectal Research Department
Level 9 East Ambulatory Care,
Royal Prince Alfred Hospital
Missenden Road,
Camperdown NSW 2050
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Country [1]
257165
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Australia
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Primary sponsor type
Individual
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Name
Dr Peter Lee
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Address
Suite 415, RPAH Medical Centre,
100 Carillon Ave Newtown NSW 2042
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Country
Australia
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Secondary sponsor category [1]
256420
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Individual
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Name [1]
256420
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Dr Christopher Byrne
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Address [1]
256420
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Suite 415, RPAH Medical Centre,
100 Carillon Ave Newtown NSW 2042
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Country [1]
256420
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Australia
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Secondary sponsor category [2]
256421
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Individual
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Name [2]
256421
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Dr Cherry Koh
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Address [2]
256421
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Source, PO BOX M157,
Missenden Road, Camperdown NSW 2050
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Country [2]
256421
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
259206
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Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
259206
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c/- Research Development Office Level 3, Building 92 Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
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Ethics committee country [1]
259206
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Australia
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Date submitted for ethics approval [1]
259206
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30/06/2010
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Approval date [1]
259206
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04/08/2010
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Ethics approval number [1]
259206
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Protocol No X10-0191 & HREC/10/RPAH/337
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Summary
Brief summary
This is a pilot study of the safety and effectives of the LIFT procedure as a treatment for fistula-in-ano. This study will collect data on patients who have undergone the LIFT procedure looking specifically at the cure rate of the procedure, post-operative sphincter function and complications. The LIFT procedure is a relatively new procedure and it has been reported to be successful at curing fistula in 82-94% of patients with minimal risk of incontinence and thus presents a very attractive alternative in the treatment of fistula-in-ano. However, prior to adaptation into mainstream practice at the Royal Prince Alfred Hospital, it was felt that a pilot study to assess the feasibility and safety of LIFT was necessary.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31316
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Address
31316
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Country
31316
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Phone
31316
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Fax
31316
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Email
31316
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Contact person for public queries
Name
14563
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Dr Peter Lee
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Address
14563
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Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
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Country
14563
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Australia
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Phone
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+61 2 9519 7576
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Fax
14563
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+61 2 9519 1806
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Email
14563
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[email protected]
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Contact person for scientific queries
Name
5491
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Dr Peter Lee
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Address
5491
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Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
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Country
5491
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Australia
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Phone
5491
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+61 2 9519 7576
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Fax
5491
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+61 2 9519 1806
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Email
5491
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[email protected]
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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.
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