LITA trial: A randomized controlled trial of ligation of the intersphincteric fistula tract versus transanal advancement flap repair

Fistulotomy is the only fistula treatment that actually works most of the time.
A major drawback of this procedure is the need for sphincter division with
subsequent continence disturbances. Therefore fistulotomy is not appropriate
for patients with a transsphincteric fistula, passing through the upper or
middle third of the external anal sphincter. The principal goal in the
treatment of high transsphincteric fistulas is healing without impaired
continence. In contrast to fistulotomy, transanal advancement flap repair
(TAFR) provides a more useful tool to minimize sphincter damage. However, it
has become clear that this procedure fails in one of every three patients.
Until now, no predictive factors for failure have been identified. In a
previous study the outcome of repeat flap repair was examined in 26 patients,
who encountered a failure after the initial procedure. In all these patients
complete healing of the advancement flap was noticed, except at the site of the
original internal opening. This remarkable clinical finding and the lack of
predictive factors for failure has made the question whether ongoing disease in
the remaining tract contributes to persistence of the fistula after flap
repair. Most of the remaining tract is located in the intersphincteric plane
near the origin of the fistula. Recently, ligation of the intersphincteric
fistula tract (LIFT) has been introduced as a new sphincter preserving
procedure. Rojanasakul was the first to describe this new technique. He
observed primary healing of the fistula in 94 percent of his patients. Another
report from Malaysia also revealed high healing rates, exceeding those obtained
with the current sphincter saving techniques. However, recent reports from the
USA showed more modest results, indicating that the LIFT procedure, like the
flap repair, fails in one of every three patients. Flap repair is rather
demanding, whereas LIFT seems to be more easy to perform. We assume that this
simple procedure is associated with less postoperative pain, shorter hospital
stay and faster resumption of work. Therefore we questioned whether LIFT would
be an attractive alternative for TAFR in the treatment of high transsphincteric
fistulas and could replace TAFR as the treatment of choice. To investigate this
we plan to start a randomized control trial.

Aim of the present study is to investigate whether LIFT or TAFR is the
preferable treatment for high transsphincteric fistulas-in-ano of
cryptoglandular origin.

Randomized controlled trial.

The burden and risks associated with participation is limited to one of the two
surgical techniques. The number of site visits and physical examinations is the
same as in the current standard protocol. One additional anal manometry will be
done in all patients 3 months postoperatively. Anal manometry is necessary to
identify anal sphincter defects. Participants are asked to fill in quality of
life questionnaires (SF-36, EQ-5D and FIQL) and an impairment of fecal
continence questionnaire (RFISI) before surgery, at 1, 2 and 8 weeks
postoperatively and 6 months postoperatively. Participants are asked to give a
pain score using the visual analogue scale at day 1, 2, 3, 4, 5, 6 and 7 and at
week 2 and 8 postoperatively.