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Use of laser in the treatment of perianal fistulas


- candidate number28006
- NTR NumberNTR6892
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-okt-2017
- Secondary IDsNL60042.068.17 METC 172018
- Public TitleUse of laser in the treatment of perianal fistulas
- Scientific TitleUse of laser in the treatment of perianal fistulas (Anorectale Fistel Laserstudie)
- ACRONYMArFiLaS
- hypothesisPerianal fistulas are a common disorder, estimated to occur in 12.3 per 100.000 men and 8.6 per 100.000 woman.1 Symptoms caused by a perianal fistula are pain and involuntary loss of gas, fluids or faeces. Besides these symptoms, complaints of itching and symptoms of infections are reported. These complaints often result in social embarrassment and loss of quality of life.

Laser treatment is a new technique in the treatment for perianal fistulas which claim to result in none or only minimal damage to the sphincter muscles. Preliminary results show a closure rate ranging from 71,4% -89%.12-14 Until now, studies are small (n= 11 - 50) and no validated questionnaires were used to objectively assess continence and quality of life.

Our hypothesis is that treatment of peri-anal fistula with laser ablation is associated with equal closure rates compared to current therapies. As secundairy outcome, quality of life, postoperative pain and incontinence will be assessed.
- Healt Condition(s) or Problem(s) studiedPerianal fistula, Laser treatment, Ablation therapy
- Inclusion criteriaage: 18 – 80 years
able to understand informed consent
primary fistula
high trans- and intersphincteric fistulas
one fistula tract, no secondary tracts, proven with MRI
- Exclusion criteriapregnancy
local malignancy
Crohn’s disease or ulcerative colitis
a traumatic or iatrogenic lesion
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2021
- Target number of participants100
- InterventionsFor this procedure we will use a 1470nm diode laser -10W. A wavelength of 1470nm allows the fistula to shrink with the use of less power, thus reducing the potential damage of tissue around the tract
- Primary outcomehealing rate
- Secondary outcomeQuality of life
Post operative pain
Functional outcome and risk of incontinence
- TimepointsThe fistula will be considered healed if the external opening is closed and no discharge or pain or perianal swelling is experienced. Recurring of these symptoms was defined as a recurrent fistula. Treatment failure is defined if there is still discharge coming out of the external opening at 3 months follow-up.

Secondary endpoints are quality of life, postoperative pain and incontinence. Patients will be asked to grade their pain on a visual analogue scale (VAS: 0 no pain; 10 worst imaginable pain). Quality of life will be evaluated using the SF-12 questionnaire and the FIQL questionnaire. Continence will be evaluated using the Vaizey and FIQL score.
Follow-up is planned at 6,12, 24 and 52 weeks postoperatively. Questionnaires are completed preoperatively and during al follow-up moments.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. Wouda
- CONTACT for SCIENTIFIC QUERIES S. Breukink
- Sponsor/Initiator Academisch Ziekenhuis Maastricht (azM)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryPerianal fistulas are a common disorder, estimated to occur in 12.3 per 100.000 men and 8.6 per 100.000 woman. Symptoms caused by a perianal fistula are pain and involuntary loss of gas, fluids or faeces. Besides these symptoms, complaints of itching and symptoms of infection are reported. These complaints often result in social embarrassment and loss of quality of life. The mucocal advancement flap is considered as one of the best surgical treatments for high perianal fistula repair. This technique is based on closure of the internal opening of the fistula tract. In one out of three patients mucosal flap repair fails. Possible factors for failure are incomplete clearance of pus and debris, incomplete closure of the internal opening or other technical failures, or inappropriate host response in patients with risk factors like smoking of diabetes. Besides a high recurrence rate, the mucosal advancement flap is also associated with impaired incontinence, rates have been described as high as 35%.
Laser treatment is a new technique in the treatment of perianal fistulas which claim to result in none or only minimal damage to the sphincter muscles. Preliminary results show a closure rate ranging from 71,4%-89%. Until now, studies are small (n=11-50) and no validated questionnaires were used to objectively assess continence and quality of life.
Our hypothesis is that treatment of perianal fistula with laser ablation is associated with equal closure rates compared to current therapies. As secondary outcome, quality of life, postoperative pain and incontinence will be assessed.
- Main changes (audit trail)
- RECORD12-okt-2017 - 28-dec-2017


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