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Trial registered on ANZCTR


Registration number
ACTRN12611000522910
Ethics application status
Approved
Date submitted
16/05/2011
Date registered
20/05/2011
Date last updated
20/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial comparing ligation of the intersphicteric fistula tract vs advancement flap for complex anorectal fistulas requiring intial seton drainage
Scientific title
Does ligation of the intersphicteric fistula tract provide at least a 40% improvement in recurrence rate compared with anorectal advancement flap: A randomised controlled trial comparing ligation of the intersphicteric fistula tract with advancement flap for complex anorectal fistulas requiring intial seton drainage
Secondary ID [1] 262182 0
None
Universal Trial Number (UTN)
None
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex anorectal fistulas where setons were previously inserted because fistulotomy was deemed to risk significant incontinence 265865 0
Condition category
Condition code
Oral and Gastrointestinal 268048 268048 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
A probe was inserted into the tract an incision then made in the intersphincteric groove and the fistula tract identified in this space. Once the tract is dissected free it is encircled and the probe removed. The fistula tract is then divided and transfixed both sides with 3/0 PDS. The external opening is left open the internal opening is curetted and closed with a vicryl suture. This is a single intervention. Operation duration is approximately 10 minutes.
Intervention code [1] 264589 0
Treatment: Surgery
Comparator / control treatment
A full thickness flap consisting of mucosa and submucosa and the internal anal sphincter was mobilised from the level of the dentate line cephalad. The base of the flap was at least twice as wide as its apex to ensure adequate blood supply to the distal end. The fistula tract was curetted and the mucosa of the internal sphincter opening excised. The edge of the flap was advanced onto the dentate line and sutured without tension over the internal opening using vicryl. This is a single intervention. Operation duration is approximately 40 minutes.
Control group
Active

Outcomes
Primary outcome [1] 266763 0
To determine if ligation of the intersphicteric fistula tract provides at least a 40% improvement in recurrence rate over anorectal advancement flap for complex anorectal fistulas after initial seton drainage. This outcome will be assessed by clinical examination, history and if required MRI and ultrasound.
Timepoint [1] 266763 0
Patients were reviewed in clinics at weeks 2, 4 and 16 then annually thereafter.
Secondary outcome [1] 276340 0
Complications
Timepoint [1] 276340 0
At each clinical and history interview: at weeks 2, 4 and 16 then annually thereafter
Secondary outcome [2] 276351 0
Pain
Timepoint [2] 276351 0
At 1 month post operatively by an independent research nurse using a visual analogue scale (1-10)
Secondary outcome [3] 276352 0
Satisfaction
Timepoint [3] 276352 0
At 1 month post operatively by an independent research nurse using visual analogue scale (1-10)
Secondary outcome [4] 276353 0
Bowel function: return to normal healthy bowel function
Timepoint [4] 276353 0
At two weeks postoperatively by interview
Secondary outcome [5] 276354 0
Time taken to resume normal activities
Timepoint [5] 276354 0
One month postoperatively by interview
Secondary outcome [6] 276355 0
Incontinence
Timepoint [6] 276355 0
Pre and one month post operatively by an independent research nurse using using the Cleveland Clinic Florida Fecal Incontinence Score(0-20, 0=continent)

Eligibility
Key inclusion criteria
Patients with transsphincteric or complex fistulas were entered into the study. Fistulas were classified as complex if any of the following were present: tract crossing more than 30% to 50% of the external sphincter, anterior fistula in a woman, multiple tracts, recurrent fistula, pre-existing incontinence or Crohns disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Crohns disease were excluded

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)
The study arm was placed in a sealed opaque envelope with the participant identification number on the front and given to the surgeon prior to surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Independent unrestricted parallel randomization was performed prior to study commencement using a computer-generated sequence.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Only participants were blinded as to study group.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267083 0
University
Name [1] 267083 0
James Cook University
Country [1] 267083 0
Australia
Primary sponsor type
Individual
Name
Yik Hong Ho
Address
Professor of Surgery and Head of Surgery
Department of Surgery School of Medicine, Townsville and the Australian Institute of Tropical Medicine, within the North Queensland Centre for Cancer Research, James Cook University, Townsville, QLD 4811, Australia
Country
Australia
Secondary sponsor category [1] 264177 0
University
Name [1] 264177 0
James Cook University
Address [1] 264177 0
Department of Surgery School of Medicine, Townsville and the Australian Institute of Tropical Medicine, within the North Queensland Centre for Cancer Research, James Cook University, Townsville, QLD 4811, Australia
Country [1] 264177 0
Australia
Other collaborator category [1] 252002 0
Individual
Name [1] 252002 0
Bettina Schultze
Address [1] 252002 0
Department of Surgery School of Medicine, Townsville and the Australian Institute of Tropical Medicine, within the North Queensland Centre for Cancer Research, James Cook University, Townsville, QLD 4811, Australia
Country [1] 252002 0
Australia
Other collaborator category [2] 252003 0
Individual
Name [2] 252003 0
Chris Mushaya
Address [2] 252003 0
Department of Surgery School of Medicine, Townsville and the Australian Institute of Tropical Medicine, within the North Queensland Centre for Cancer Research, James Cook University, Townsville, QLD 4811, Australia
Country [2] 252003 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267087 0
Ethics Committee The Mater Miscordiae Hospital
Ethics committee address [1] 267087 0
Ethics committee country [1] 267087 0
Australia
Date submitted for ethics approval [1] 267087 0
Approval date [1] 267087 0
26/04/2011
Ethics approval number [1] 267087 0
The Mater Miscordiae Hospital Ethics Committee Townsville does not provide HREC numbers. We are happy to email a scanned copy of the ethics approval letter. An original collaborator of the study received verbal ethics approval prior to commencement of this study. The sponsor was of the understanding that this process was complete. The current collaborators could not find the approval documentation when when conducting data verification, so re-applied. Some delays in this 2nd process occured due to postponement of HREC meetings due to cyclonic conditions etc.

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

Contacts
Principal investigator
Name 32614 0
Address 32614 0
Country 32614 0
Phone 32614 0
Fax 32614 0
Email 32614 0
Contact person for public queries
Name 15861 0
Lynne Bartlett
Address 15861 0
School of Public Health, Tropical Medicine & Rehabilitation Science within the North Queensland Centre for Cancer Research, James Cook University, Townsville QLD 4811, Australia
Country 15861 0
Australia
Phone 15861 0
+61 7 4796 1721
Fax 15861 0
+61 7 4796 1767
Email 15861 0
lynne.bartlett@my.jcu.edu.au
Contact person for scientific queries
Name 6789 0
Yik Hong Ho
Address 6789 0
Department of Surgery School of Medicine, Townsville and the Australian Institute of Tropical Medicine, within the North Queensland Centre for Cancer Research, James Cook University, Townsville, QLD 4811, Australia.
Country 6789 0
Australia
Phone 6789 0
+61 7 4796 1417
Fax 6789 0
+61 7 4796 1401
Email 6789 0
yikhong.ho@jcu.edu.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.