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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.
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.
Secondary ID [1] 252071 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fistula-in-ano 257611 0
Condition category
Condition code
Surgery 257788 257788 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256698 0
Treatment: Surgery
Comparator / control treatment
N/A - This is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258657 0
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.
Timepoint [1] 258657 0
Patients are assessed prior to surgery and they will also be followed-up at 6 weeks, 3, 6, 12 months post surgery.
Secondary outcome [1] 264634 0
To determine the cure rates of the LIFT procedure.
Patient will be assessed clinically as well as anorectal physiology including endoanal ultrasound.
Timepoint [1] 264634 0
Patients are assessed prior to surgery and they will also be followed-up at 6 weeks, 3, 6, 12 months post surgery.
Secondary outcome [2] 264635 0
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.
Timepoint [2] 264635 0
Patients are assessed prior to surgery and they will also be followed-up at 6 weeks, 3, 6, 12 months post surgery.
Secondary outcome [3] 264636 0
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.
Timepoint [3] 264636 0
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.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2010
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] 257165 0
Self funded/Unfunded
Name [1] 257165 0
Colorectal Research, Royal Prince Alfred Hospital (RPAH)
Country [1] 257165 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] 256420 0
Individual
Name [1] 256420 0
Dr Christopher Byrne
Address [1] 256420 0
Suite 415, RPAH Medical Centre,
100 Carillon Ave Newtown NSW 2042
Country [1] 256420 0
Australia
Secondary sponsor category [2] 256421 0
Individual
Name [2] 256421 0
Dr Cherry Koh
Address [2] 256421 0
Source, PO BOX M157,
Missenden Road, Camperdown NSW 2050
Country [2] 256421 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259206 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 259206 0
Ethics committee country [1] 259206 0
Australia
Date submitted for ethics approval [1] 259206 0
30/06/2010
Approval date [1] 259206 0
04/08/2010
Ethics approval number [1] 259206 0
Protocol No X10-0191 & HREC/10/RPAH/337

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

Contacts
Principal investigator
Name 31316 0
Address 31316 0
Country 31316 0
Phone 31316 0
Fax 31316 0
Email 31316 0
Contact person for public queries
Name 14563 0
Dr Peter Lee
Address 14563 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
Country 14563 0
Australia
Phone 14563 0
+61 2 9519 7576
Fax 14563 0
+61 2 9519 1806
Email 14563 0
peterjmlee_23@yahoo.com.au
Contact person for scientific queries
Name 5491 0
Dr Peter Lee
Address 5491 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave Newtown NSW 2042
Country 5491 0
Australia
Phone 5491 0
+61 2 9519 7576
Fax 5491 0
+61 2 9519 1806
Email 5491 0
peterjmlee_23@yahoo.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.