An interventional study of Laser treatment of anal fistula and RAF in Fistula in Ano and Rectal Fistula, sponsored by University Hospital, Antwerp. Status unknown at 5 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.
A prevalent and complex fistula type is the high transsphincteric (TS) fistula. It typically runs through the upper two-thirds of the external anal sphincter (EAS) and is, due to the high risk of fecal incontinence, not suitable for fistulotomy and sphincter sparing treatment is required. To be included in this trial the participants should have a single, continuous TS fistula of cryptoglandular origin, that is treated by loose seton drainage for at least 2 months and is mapped by MRI. Participants with IBD, hidradenitis suppurativa or a malignant fistula will be excluded. Intervention Fistula Laser Closing (FiLaCTM) (Biolitec, Germany) is an endofistular technique, using a radial-emitting laser fiber that emits laser light with a maximum penetration depth of 2 - 3 mm. It destroys both the crypt gland and the additional epithelial layer of the fistula without damaging the sphincter. The fiber is inserted until the internal opening, activated and pulled backwards slowly, allowing the laser to have its effect. The external opening is excised and the internal opening is closed with a single absorbable suture. Rectal advancement flap is currently the gold standard for sphincter sparing treatment of high transsphincteric fistulae. The fistula is cored out and an advancement flap is made of mucosa and submucosa. The opening of the fistula in the flap is excised, the residual internal opening is closed with absorbable suture and the flap is sutured below the fistula to the anoderm. The advancement flap is a difficult technique that requires a relatively large transanal dissection that results in postoperative pain and may lead to disturbances in continence. Preliminary results with the Filac technique show fistula healing rates comparable to the advancement flap. Due to its simplicity, speed and minimal invasiveness the investigators expect a benefit for the participants in terms of postoperative pain, operating time and quality of life.
193 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.
This study's planned enrollment of 176 is above the median of 68 across 132 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Group to be actively treated with laser assisted fistula surgery
Procedure: Laser treatment of anal fistula
Group to be actively treated with a rectal advancement flap.
Procedure: RAF
using a radial laserprobe to treat transsphincteric fistula
Also known as: FiLAC - LAFT
current golden standard in transsphincteric fistula surgery
Also known as: rectal advancement flap
Primary fistula closure after index laser or flap treatment
Success rate (number of patients) of laser/flap treatment defined as full healing (fistula closure) after the index procedure
Time frame: 6 months
Secondary Fistula closure
Secondary success rate (number of patients) defined as full healing (fistula closure) after a second procedure (either rectal advancement flap, laser treatment, fistulotomy)
Time frame: 6 months
Postoperative Pain
Reported pain after laser or flap treatment: measured using the visual analog scale - VAS where 0 = no pain; 10 = worst pain imaginable,
Time frame: 6 months
Postoperative fecal incontinence
Reported fecal incontinence after laser or flap treatment: measured using the Vaizey score where minimum score 0 = perfect continence; maximum score 24 = totally incontinent)
Time frame: 6 months
Postoperative wound complications
Reported wound complications after laser or flap treatment defined as wound dehiscence or bleeding as reported on the adverse event forms
Time frame: 6 months
Postoperative Quality of Life
General postoperative well being and ability to partake in daily life and daily tasks (specific role functioning) measured and scored using the SF 36 questionnaire (consisting of 8 weighted scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role, functioning, and mental health. The lower the score the more disability. The higher the score the less disability) This outcome is measured in all participants after the initial procedure (index flap or laser treatment) as well as after a second procedure (in case of recurrence)
Time frame: 6 months
Primary Recurrence
Number of participants presenting with a clinical recurrence or residual fistula after initial and laser/flap treatment (index procedure)
Time frame: 6 months
Secondary Recurrence
Number of participants presenting with a clinical recurrence or residual fistula after the second procedure (Laser - Flap - Fistulotomy - Ligation of the fistula tract, video-assisted fistula treatment)
Time frame: 12 months
Identify predictive factors for clinical fistula healing to determine the treatment indications.
This outcome evaluates the correlations between patients'/ fistula's clinical characteristics and primary healing rates
Time frame: 6 months
Plan to share: No
Started Mar 2022 (actual). Primary completion is estimated for Sep 2025, 42 months after the start.
Of 58 non-industry interventional studies with no phase under Rectal Fistula, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 42 months is above that.
Counting every sponsor, half of 61 studies reached it within 27 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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