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S. Rahman and V. L. Tsikitis
Incontinence rate
Median
follow-up
(months) Healing rate Recurrence Rate
Number of
subjects
100 60%
22 59% 41%
pre vs post-
treatment: 0.67,
0.49
LIFT 498 69.1% 21.9% 1.6%
Procedure Population
Seifarth (2021) ERAF Crohn’s stula 55 6.3 47%
Stellingwerf (2018) ERAF High perianal stula 797 3–84 74.6% 25.6% 7.8%
Table 39.1 (continued)
Author (year)
Cryptoglandular
stula
LIFT-plug 117 94% 0 0
Wexner (2020) LIFT Transsphincteric
Han (2016) LIFT High TSF 118 6 83.9% 0 0
stula
Rojanasakul (2017) LIFT High TSF 71 60%
Low TSF 92%
Altomare (2009) Fibrin glue TSF 39 12 39.5% Wexner scores
TSF 25 87.5% 1.79, 5.1
Mid and High TSF 28 20.6 68% 32%
Seton (majority
cutting seton)
Fistulectomy
with seton
Oca (2011) 2-stage: (1)
followed by (2)
Fibrin glue
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Incontinence rate
Median
follow-up
(months) Healing rate Recurrence Rate
441
Number of
subjects
Procedure Population
Author (year)
FIAT Trial (2021) Plug TSF 146 12 54%
146 55%
Surgeons
preference
Hansen (2019) Plug TSF 36 18 39% 26.3% 0%
Wilhelm (2017) FiLaC TSF 90 25.4 61.1% 0%
454 23.7 67.3% 1%
Low TSF 10 20% 0%
with TSF
Marref (2019) FiLaC High TSF 45 6.3 60% 0%
Elfekl (2020) FiLaC Fistula-in-ano 69%
98 13 73.5%
Meinero (2011) VAAFT Fistula-in-ano 75.5%
788 9 85.8% 14.2%
with high TSF
with high TSF
Meinero (2020) VAAFT Fistula-in-ano 96 36 83.3%
Emile (2017) VAAFT Fistula-in-ano 66.5%
a
transsphincteric stula (TSF)
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Table 39.2 Comparison of available approaches for management of transsphincteric stulas
Patient population
Patients with transsphincteric
stulas
Intervention Comparator
Fistulotomy Sphincter-saving
approaches
S. Rahman and V. L. Tsikitis
Outcomes studied
Healing rate,
continence
Results
Fistulotomy
After the anatomy of a stula is determined, a stulotomy is performed by cannulating the stula and dividing the overlying tissue with electrocautery. The wound is
then left to heal by secondary intention after either fulguration, electrocautery, or
marsupilizing the stulous tract. Historically, a stulotomy is appropriate for stulas below the dentate line, including supercial, intersphincteric, and low transsphincteric stulas. Success rates are generally high, however fecal incontinence
rates are elevated in stulotomies performed for complex or high transsphincteric
stulas.
Abramowitz in 2015 performed a prospective multi-center trial and performed
seton placement and 2-stage stulotomy for patients with high transsphincteric stulas. They found a statistically signicant increase in both the Wexner score
(median score 1 pre-procedure and 4 at 1-year follow-up) and an increase in the
Vaizey score (1.5 pre-procedure vs 4 at 1-year follow-up). The median scores in the
1-stage stulotomy group were not statistically signicant (Wexner 1 vs 2 at oneyear follow-up; Vaizey 2 vs 3 at one-year follow-up) [1]. Papaconstantinou 2017
study found a stulotomy an effective way to manage a low or mid-transsphincteric
stula in patients with Crohn’s disease. However, 20% of these patients demonstrated incontinence which was dened as uncontrolled passage of atus or <1 teaspoon passage of mucus in a 24-h period [2]. Wang etal’s report is concurrent with
the existing literature as they had no stula recurrence following seton then stulotomy for low transsphincteric stulas. They also reported 0% incontinence rates
however no validated questionnaires and scoring systems were utilized [3]. Overall,
stulotomy in one-stage, two-stage, or followed by seton placement is appropriate
for patients with short tract stulas and overall should be avoided in complex or
high-transsphincteric stulas given the increased risk of incontinence.
Seton
Two types of setons have been described to date. The rst is a loose, non-cutting
seton whose goal is to promote drainage, control sepsis, and allow for tract brosis.
In higher risk patients, they can be left for years and used as denitive treatment;
while for others it can be used in preparation for a secondary procedure. Loose
setons are well tolerated with minimal risk. A cutting seton is serially tightened over
time to bring the stulous tract closer to the skin. The goal is to create a brous tract
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under the skin in an effort to preserve sphincter-function, although incontinence
rates are reported to be increased compared to non-cutting setons.
Setons continue to be used with good success rates, even for high transsphincteric stulas. The reported healing rate at 12-months was reported to be 97.2% in a
series of 72 patients when a cutting seton (silk size 2) was used with only 2 patients
(2.8%) recurring at 6-months. Of the 72 patients, 66.7% required two additional
procedures for seton tightening and 33.3% required three procedures for tightening.
Flatus incontinence occurred in 1 patient (1.4%) however no standardized questionnaires were used. Additionally, pruritus with perianal discharge was noted in 4
patients (6.9%) and was not considered to be incontinence [4]. This is in contrast to
a large series review of 1460 patients that underwent a cutting seton. The authors
report an overall incontinence rate of 12% and signify that an increased rate of
incontinence was shown when location of the internal stula opening was more
proximal in the anal canal [5]. Alternatively, the use of a loose seton in a series of
251 patients with a high TSF had a near 90% healing rate with 10.3% recurring,
however, half the subjects in their study had undergone previous surgery for stulain- ano [6].
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Endorectal Advancement Flap
The endorectal advancement ap (ERAF) is typically used as a second-stage procedure following either seton placement or stulectomy. With this procedure, a
trapezoidal- shaped ap is created which includes the mucosa, submucosa, and a
few bers of the internal sphincter muscle. The internal opening of the stula tract
is then sutured closed and covered with the ap.
Perhaps one of the best long-term studies to recently be published on the use of
ERAF was in a series of 115 patients with a transsphincteric stula with a mean
follow-up of 13years. They reported a recurrence rate of 23.8%, with 90% of the
recurrences occurring within the rst year. Recurrence was dened as recurrent
stula tract, but also included presence of an abscess which may partially explain
this higher recurrence rate. Taking this into account, the overall success rate was
76.2%. When assessing incontinence using the Wexner score, overall continence
worsened in 16.9% of cases with a mean score of 0.78 pre-procedure compared to
1.16>10years at the conclusion of the study. When specically assessing patients
with normal continence pre-procedure, overall incontinence was documented in
10.5% of cases after ERAF [7]. This data is similar to a recent meta-analysis of 30
studies which included ERAF for the treatment of high perianal stulas in 797
patients. They reported an overall success of 74.6%, recurrence in 25.6%, and an
incontinence rate of 7.8%. The pooled data had a variation in follow-up which
ranged from 3–84months; however, a subgroup analysis of 12 studies with a minimum follow-up of 12-months demonstrated an overall success rate of 73.6% [8].
Other reported data continue to demonstrate the poor healing rates with ERAF in
patients whose etiology for their stula is due to Crohn’s disease with 47% healed,
compared to 60% in non-Crohn’s patients, although this did not reach statistical
signicance (p=0.088) [9].
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S. Rahman and V. L. Tsikitis
Ligation ofIntersphincteric Fistula Tract
The ligation of intersphincteric stula tract (LIFT) procedure was designed as a
total sphincter-preserving technique rst described in 2007. It is used as a second
stage procedure after the stula tract has matured, either with or without a seton. In
this procedure, the stula tract is cannulated with a probe, then an incision is made
over the intersphincteric groove and dissected down to the level of the stula tract.
Once the tract is circumferentially isolated, it is suture ligated and divided sharply
without dividing the sphincter complex. Historically, LIFT is not used for very high
stula tracts due to the difculty in isolating the intersphincteric plane.
In a 2016 study, Han etal. performed a randomized prospective study comparing
LIFT vs LIFT with addition of a porcine plug placed into the curetted stula tract.
The healing rate was 83.9% healing in the LIFT group and 94% in the LIFT-plug
group. There was no signicant difference in the Wexner scores pre- and postoperatively and they ranged from 0 to 1 at 6-months post-op. They concluded that
LIFT is an effective surgical technique with low impact on fecal incontinence [10].
However, these remarkable results were not replicated by Wexner’s group who
reported a 41% recurrence rate. Of 40 patients who had a pre-operative MRI, they
stratied this data into laterality of the stula tract and concluded that posterior
transsphincteric stula tracts carried the highest recurrence rates (5/7, 71%) compared to an anterior track (1/9, 11.1%) [11]. A more recent study by the creator of
the LIFT procedure reported their ten-year experience of using the procedure. Of
the 251 patients included, 56% had a low transsphincteric stula and 6% had a high
TSF.Of these, the primary healing rate was excellent in the low TSF at 92% and
only 60% in high TSF.Of the 31 patients with an unhealed stula regardless of classication, following either one or two repeat procedures (re-LIFT, stulotomy,
curettage, or spontaneous healing), only 2 of the 251 patients remained unhealed.
The overall healing rate after primary surgery and reoperation was 99.2% [12].
Fibrin Sealant
Fibrin sealants were approved for use by the FDA in 1998 for the treatment of perianal stula. Its primary benet serves as having a minimal risk to prole given that
there is no manipulation to the sphincter complex with brin administration.
However, many insurance companies will not cover these expensive products given
their reported low success rates. Fibrin sealants are not recommended as a rst-line
therapy, however given their low risk prole, they may be suitable when other surgical options are not achievable.
A 2009 randomized crossover trial was performed comparing setons to brin
glue. This study was terminated early based on interim analysis given the high failure rates seen with brin administration. At 3-months, 87.5% of patients with a TSF
who had a seton placed were healed compared to 38% in the brin arm. Of those
who failed in the brin arm, 8 of the 23 went on to receive a second brin injection
and 4/8 (50%) healed. The remaining 18/23 went on to have a seton placed and
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10/23 (60%) healed. This study did include anal manometry results and found a
poorer score in the seton compared to the brin group. However, a majority of the
setons used in this group were cutting setons. They concluded that the higher success rate with seton is counterbalanced by the higher incontinence rate and brin
should be considered for patients at higher risk for fecal incontinence [13].
Higher success rates with brin are seen when it is not used as the primary treatment modality. A 2011 study performed a stulectomy with seton in 28 consecutive
patients followed by seton removal and brin administration 12.5months after the
rst procedure. By 21months, 19/28 (68%) patients healed, of which 9 recurred.
They demonstrate that brin may serve a complimentary role in the long-term treatment of TSF [14].
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Plugs
Biosynthetic stula plugs are inserted into the stula tract and encourage tissue ingrowth and healing to close the tract. They have wide rates of healing however do
not alter incontinence given no disruption of the sphincter occurs.
The Fistula-in-ano trial (FIAT) in 2009 was commissioned to perform a randomized control trial evaluating plug use versus surgeon preference. The results of the
FIAT trial were reported in 2021. 304 subjects were recruited from 45 centers and
randomized in a 1:1 ratio to plug versus surgeon’s preference. At 12-months, 54%
of stulas in the plug arm were healed compared to 55% in the surgeon’s preference
arm. A 12-month MRI was also performed in 86% of patients and the healing rate
judged by MRI was 49% for plug and 57% for surgeon’s preference, though this
was not statistically signicant. There was also no difference in the incontinence
scores between the two groups at 12-months. These comparable results with a
higher cost procedure led to the FIAT trials conclusion that plugs are not a costeffective treatment for anal stulas in the UK NHS [15]. These results were similar
to a prior study which reported outcomes of 36 patients who had a plug inserted.
The initial healing rate was 52.8%, however by 18-months when adjusting for recurrence rate, the overall success rate was 39% [16]. These data demonstrate that plugs
should not be the treatment of choice for TSF.
Fistula Laser Closure
Fistula laser closure (FiLaC) is a new sphincter-preserving technique developed
in 2011 by Wilhelm etal. to be used in patients who were at high risk of incontinence after stulotomy [17]. The technique utilizes a radial laser probe to burn the
stula tract. This circumferential heating works by obliterating and sealing the
stula tract.
After developing the procedure, Wilhelm reported his ve-year experience with
FiLaC in a series of 117 patients, 90 of whom had a TSF. They achieved a 61%
primary healing rate, and a secondary healing rate of 88.9%, although only 5/31
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secondary procedures were repeat FiLaC [18]. A separate 2019 prospective study
reported that the only predictive factor for success with FiLaC is for high TSF’s.
The rate of healing in low TSF’s were low at 20% compared to 60% for high TSF.A
2020 meta-analysis on 7 articles encompassing 454 patients was also performed to
evaluate the efcacy of FiLaC [19]. 314/454 patients had a TSF.At a median fol-
low-up of 23.7months, 65% of patients achieved healing after primary FiLaC for
all types of stulas. They did not stratify healing rates based on stula type. Notably,
of the 158 patients who failed in the study, 97% did not achieve primary healing
while only 3% had recurrence [20].
S. Rahman and V. L. Tsikitis
Video-Assisted Anal Fistula Treatment
Video-assisted anal stula treatment (VAAFT) is a novel technique rst described
in 2006 [21]. The technique is performed by inserting a stuloscope into the external opening. The internal opening and secondary tracts are then identied. These
tracts are disrupted using electrocautery and the necrotic debris is removed using
continuous irrigation and an endobrush. Finally, the internal opening is closed using
either suture, an advancement ap, or an endostapler.
The outcomes of VAAFT were rst published by Meinero and Mori in 2011 who
reported their outcomes on a series of 98 patients, where 76% of the patient population had a high trans-sphincteric stula. These patients achieved a primary healing
rate of 73.5% by 6-months [21]. Meinero also recently published 3-year outcomes
on patients undergoing VAAFT in 2020. This was a different patient population
from their original study, and they again had convincing results. By 3-years, 80/96
(83.3%) of patients achieved healing of their stula [22]. These results were corroborated by a meta-analysis performed in 788 patients, 66.5% of whom had a high
or complex FIA.At a median follow-up of 9-months, 14.2% of patients had a recurrence with a heal rate of 85.8%. Interestingly, when stratied by type of closure
used for the internal opening, the highest recurrence rate occurred after advancement ap (25%), followed by suture-closure (17.7%), then stapler (15.3%) [23].
This data demonstrates VAAFT as being a promising management option for the
treatment of stulas in the future.
Conclusion andPersonal View
One of the difculties in evaluating studies related to the treatment of TSFs are that
many of the patients have had one or more prior surgical procedures prior to study
enrollment. Additionally, outcomes are not all dened the same. For example,
patients’ outcomes will be reported as “primary healing” based on the study intervention rather than accounting for the prior stula procedures they have received.
The denition of fecal or stool incontinence also vary among studies, although the
use of the Wexner and Vaizey scores provide an objective measure that help alleviate this issue.
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In our practice, the approach to TSF depends on the length of the stula tract and
patients’ current anatomy and sphincter function. Overall, after control of the initial
infection and possible sepsis, our goal for subsequent procedures is to balance the
risk of fecal incontinence with the risk of recurrence while addressing the patients’
needs. Our initial approach includes either an MRI of the pelvis or an exam under
anesthesia to delineate the stula tract. During an exam under anesthesia, after
delineation of the stula tract, we may concurrently proceed with either a simple
stulotomy if the tract is short and supercial or with a placement of a draining
seton if the stula tract is long and complex. A draining seton may stay for a period
of 8–12weeks and then we will proceed with either a LIFT or ERAF procedure.
Our preference is ERAF over LIFT when the stula tract is long and complex; however, studies demonstrate that results are equivalent between the two procedures.
At this juncture, complex TSF still poses a challenge to the colorectal surgeon; it
is fundamental that the patient understands the anatomical limitations and the technical complexities associated with each approach and shared decision-making may
be entertained addressing the patients’ needs and preferences.
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