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Project
TBM project: LATFIA-trial: Laser Assisted Treatment of Fistula In Ano (FWOTBM7)
Patient
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 patient 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. Patients 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.
Comparison
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.
Outcome
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 we expect a
benefit for the patient in terms of postoperative pain, operating time
and quality of life.
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 patient 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. Patients 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.
Comparison
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.
Outcome
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 we expect a
benefit for the patient in terms of postoperative pain, operating time
and quality of life.
Date:1 Oct 2021 → Today
Keywords:Gastro-enterology, Abdominal surgery
Disciplines:Abdominal surgery
Project type:Collaboration project