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17 Fistulotomy 273
abscess, deformity, and wound complications. The skin wound was sutured in seven
studies with a weighted average healing rate without dehiscence of 68.9% (range
28.6–100%).
All studies, except one, reported data about pre- and postoperative continence
status. The weighted average rate of major fecal incontinence (i.e., incontinence to
liquid or solid stools) increased from 1.1% preoperatively to 2.7% at follow-up. The
weighted average rates of minor fecal incontinence (i.e., incontinence to gas and/or
post-defecation soiling) in the pre- and postoperative period were 8.6% and 15.4%,
respectively. However, the weighted average Cleveland Clinic score decreased from
1.6 to 1.2 at the last follow-up evaluation. Postoperatively, the overall rate of
deterioration of continence (as evaluated in patients with full continence preoperatively) was 12.4% (mainly minor fecal incontinence).
Only four studies evaluated the pre- and postoperative sphincter function of
patients undergoing FIPS, using anorectal manometry. Unfortunately, variability in
the instruments used, together with the use of either mmHg or cmH
O as unit of
2
measurement, made it impossible to pool the manometric results. Resting pressure
decreased in three out of the four studies, and in two series, such reduction reached
statistical significance. On the contrary, the squeeze pressure did not significantly
change in any study. The report by Lux and Athanasiadis (1991) showed a statistically significant reduction in anal canal length, but this finding was not confirmed by
Perez et al. (2006).
Only two studies evaluated patients’ quality of life by administering the Fecal
Incontinence Quality of Life (FIQL) scale questionnaire. At a median follow-up of
3 years, Roig et al. (2010) observed no differences in each of the four domains
evaluated between two cohorts of patients treated with FIPS and advancement flap.
Hirschburger et al. (2014) stated that pre- and postoperative FIQL scores of patients
treated with FIPS did not differ significantly.
To date, both the American and European guidelines suggest using the technique
only for low, “simple” fistulas. Fistulotomy is considered the surgical option that
guarantees good results in terms of success rate, but the sacrifice of the anal
sphincters could lead to various degrees of postoperative fecal continence disorders.
Seyfried et al. (2018) showed that patient’s gender and high fistula tract were
associated with a worse outcome; on the contrary, we were unable to identify any
risk factors for recurrence (Litta et al. 2019). In fact, in our experience the procedure
was effective regardless of fistula type (i.e., primary or recurrent), gender, or
complexity of the disease. We think that this result is very important, because it
demonstrates the efficacy of the technique in all patients, regardless of their specific
characteristics. These data differ from other published studies on several techniques
where the healing rate varied between subgroups of patients. The morbidity rate was
low, with only 2% of patients having a sphincter dehiscence (the most feared
complication after FIPS) requiring a redo sphincteroplasty (Litta et al. 2019,
2021). In a previously published systematic review, this risk ranged from 0 to 8%,
increasing with the amount of sectioned sphincter.
Adding the step of sphincter reconstruction to the simple lay-open fistulotomy does
not significantly increase surgery time, while positively affecting wound healing and
274 P. Campennı`et al.
avoiding (in the vast majority of cases) a deep scar at the anal verge that may lead
to deformity and fecal soiling/seepage. We think that FIPS is a good option also for
simple fistulas (intersphincteric and low transphincteric), because the suture of low
sphincter(s) could reduce the risk of anal deformity (“key-hole” look) as seen
frequently after simple fistulotomy, where the risk of continence impairment
(mostly soiling and seepage) is not negligible. Based on these considerations,
FIPS seems suitable in patients with either middle-low transphincteric or
intersphincteric fistulas. However, additional patients’ characteristics should be
carefully considered such as risk of incontinence and presence of sepsis. The
results of this and previously published studies show that FIPS provides significant
improvement of patients’ continence status in the long term compared to that
observed after simple fistulotomy.
Indeed, the impact of surgery on patient satisfaction and quality of life after surgery
is crucial. In some studies, it is argued that the risk of fecal incontinence is of utmost
importance, but also that a high recurrencerate (with the consequent need of numerous
surgical procedures) will even be more detrimental for the patient. In this regard, recent
studies showed that patient satisfaction was high, both in patients undergoing
fistulotomy for simple anal fistula and in staged fistulotomy for complex anal fistula,
with an improved quality of life in both groups. Our results confirmed that patient
satisfaction rate after FIPS was high, but negatively correlated to postoperative onset
of continence disturbances. Similarly, other papers showed that fistulotomy was the
strongest risk factor for postoperative continence impairment, and that the severity of
incontinence correlated to anal fistula complexity, with a negative impact on patients’
quality of life (Jayarajah et al. 2017;Jordánetal.2010).
6 Fistulotomy in Crohn’s Disease (CD)
About 30% of patients affected by perianal CD develop a fistula or abscess and more
than half develop anal canal stenosis which, in most cases, requires demolition
surgery. Anorectal fistulas have variable clinical presentation and history. Healing
is not frequent, but more probably it can be obtained when the fistula is low,
superficial, or intersphincteric, with actively draining fistulous orifices. When the
fistula tract is high or the path of the fistula is blind, the course becomes problematic.
In this case, the most frequent presentation is a perianal sepsis which, generally
developing from the crypto-glandular area at the height of the dentate line, evolves
toward the formation of an abscess that requires surgical drainage and generally has
a rather slow resolution. Evaluation under anesthesia, in these cases, represents the
gold standard in the diagnosis of fistulas and abscesses, with a sensitivity of over
90%, the risks deriving from the procedure are rare, and also allows the execution of
any contextual surgical procedures. Magnetic resonance imaging (MRI) of the pelvis
has a sensitivity between 76 and 100%, identifying the fistulous path and its
extension, even when this is not identifiable on physical examination. It can also
be used to evaluate the response to medical and surgical therapies.
17 Fistulotomy 275
Endoanal ultrasound shows a sensitivity rate ranging between 56 and 100%; it
also allows the identification of the fistula tract with the introduction of hydrogen
peroxide. Although simpler to perform and less expensive than MRI, it has the
disadvantage of being operator-dependent and not often being performed in patients
with anorectal stenosis.
Therefore, to objectively evaluate and quantify the activity of perianal disease,
various indices have been developed, the most used of which is the Perianal Crohn’s
Disease Activity Index (PCDAI). The system provides for the evaluation of five
parameters related to the presence of a fistula, for each a score from 0 to 4 is
assigned: anal discharge, pain and limitation of daily activities, reduction of sexual
activity, type of perianal lesion, and consistency of the lesion. The advantage of this
index lies in the possibility of evaluating the quality of life of these patients at the
same time as the results of the therapeutic strategy.
In the past, surgery had a crucial role in the therapy of perianal Crohn’s disease,
but today, considering the possible and invalidating complications following surgery, the preferred initial approach is most frequently conservative. Excellent results
have been obtained by associating medical therapy with surgical therapy and new
approaches with staminal cell are under investigation.
The effectiveness of the simple fistulotomy (only lay-open) was demonstrated in
an old study conducted on 18 patients with low Crohn’s disease fistulas, in which
10 had undergone fistulotomy and 8 had simple drainage (Halme et al. 1995). All the
patients treated with fistulotomy were healed, albeit in a rather long period of time
(7.5 months on average), whereas only four of the drained fistulas had recovered. In
the same study 17 patients with high fistulas had undergone fistulotomy, but only
four had healed and seven had required a proctectomy. The closure rate of fistulas
obtained at St Mark’s Hospital with the use of fistulotomy is equal to 81%, comparable to 83% obtained with the placement of seton.
This technique is not used in the treatment of anterior fistula in female, high and
complex fistulas, mainly for the risk of fecal incontinence.
7 Postoperative Care
Surgery on the anal and peria nal region could lead to a long and often painful
postoperative recover y period. Fistulotomy is not an exception; swelling, pruritus,
and local pain are among the most referred symptoms. In order to partially control
them, hygiene is vital.
Daily washing of perianal region with common soap and/or sitz bath are strongly
recommended.
In addition, stools should always be maintained formed, but not too firm. The
passing of hard stool may in fact create lesions in the mucosa and anal skin; on the
other hand, liquid stools or diarrhea carry acids and are equally harmful. Adequate
fiber-rich diet, plentiful assumption of water, and, if necessary, fiber complements
are all key elements in assuring the right consistency of stools.
Analgesic therapy must be guaranteed to every patient.
276 P. Campennı`et al.
8 Complications and Recurrence Rate
Anal fistulotomy can be considered the best anal fistula treatment option, providing
a perfect surgical field view, allowing direct access to the source of chronic
inflammation (i.e., the intersphincteric space), and demonstrating high healing
rates. Controversy exists concerning the risk of continence impairment associated
with the approach. Several researchers consider the risk as acceptable, but
for many others it is too high; definitely, the surgeon expertise is pi votal in
minimizing it.
Three decades ago, Parkash et al. proposed immediate sphincter reconstruction
after fistulotomy, to reduce both the risk of postoperative fecal incontinence and
healing time. To date, fistulotomy with added sphincter repair seems to be able to
reduce the main consequences of simple fistulotomy: the high continence impairment rates, the risk of recurrence, and the esthetical side effects.
Our retrospective study (Litta et al. 2019) reported an overall healing rate of 93%
after FIPS (188/203 patients). It is one of largest single center studies, with the
longest follow-up period (mean follow-up was 55.9 30.9, range 12–143 months),
that assess the surgical and funct ional outcomes of the FIPS technique. All patients
were regularly followed up with a clinical and physical examination (plus an EAUS
if needed) at our institution, according to the following schedule: 1 week, 1–3–6–
12 months, and then every 6 months. Specifically, for this study, the clinical
condition of patients was updated by a standardized telephone interview. The
following main outcome measures were collected: fistula healing, continence status,
assessed by the Cleveland Clinic Fecal Incontinence score (CCFIS), onset of postdefecation soiling, morbidity rate. Incontinence was defined as an inability to control
the passage of gas, liquid, and solid stools, and also as post-defecation soiling.
Healing was defined as the absence of drainage or abscess formation, fistula closure,
and complete wound healing. Patients reporting healing or continence status doubts
during the telephone interview were invited to our institution for clinical and
physical examination.
Fifteen (7%) patients experienced fistula recurrence, which was treated by redo
FIPS in 5 (3%) patients. All of them achieved complete healing, resulting in an
overall success rate of 95%. FIPS was equally effective in primary compared to
recurrent, simple compared to complex fistulas, intersphincteric compared to transphincteric (low or high) fistulas, and in patients with or without a previous seton
placement.
Special care was taken to record the presence of continence impairment prior to
surgery. Indeed, it was not surprising to observe resolution of preexistent postdefecation soiling in six (3%) out of eight patients.
Postoperatively also the fecal continence was considered: 26 (13%) patients
sustained some minor form of continence impairment, consisting of post-defecation
soiling (20 [10%] patients) and flatus incontinence (19 [10%] patients); 12 (6%)
patients developed major fecal incontinence (to liquid and/or solid stools). The
17 Fistulotomy 277
overall CCFIS did not significantly change at last follow up (from 0.04 0.4 to
0.5 1.8) compared to baseline. However, the CCFIS increased from 0.5 1.2 to
3.7 3.6 ( p ¼ 0.005) in patients with postoperative continence impairment.
Changes in the CCFIS were detected after 3 months of follow-up, with no significant
change of its value afterwards. Six (3%) patients complaining postdefecation soiling
at baseline were fully continent at the last follow-up. Finally, “de novo” continence
impairment (minor and/or major) occurred in 24 (12%) patients reporting full
continence prior to surgery. Univariate analysis results of fecal continence factors
showed that patients with recurrent ( p ¼ 0.002) or complex ( p ¼ 0.012) anal
fistulas, and those with secondary tracts ( p ¼ 0.004) or history of seton drainage
( p ¼ 0.0001) were at a higher continence impairment risks; however, fistula
complexity was the only almost significant factor in multivariate analysis
( p ¼ 0.050).
It is well known that the results of both primary and delayed sphincteroplasty
after an obstetric trauma are good in the short and medium term, but deteriorate over
time. For this reason, skepticism exists about the long-term results of FIPS. In this
study, the overall pre- and postoperative CCFIS did not change, although it was
significantly higher in the group of patients with postoperative continence impairment. Furthermore, changes in the score were recorded up to the third postoperative
month, with no change afterwards: this indicates that the effectiveness of the
sphincter reconstruction tends to remain stable over time. This difference can be
explained by some technical and pathophysiological aspects that are different
between obstetric trauma and anal fistula.
The morbidity rate was low, with only three (2%) patients having a sphincter
dehiscence (the most feared complication after FIPS) requiring a redo
sphincteroplasty. In a previously published systematic review (Ratto et al. 2015),
this risk ranged from 0 to 8%, increasing with the amount of sectioned sphincter.
During the study patient’s satisfaction was assess with 11-point numeric rating
scale (NRS) (ranging from 0 to 10). The mean NRS was 9.3 1.6. Lower
satisfaction rates were found in patients with transphincteric ( p ¼ 0.011) or complex
( p ¼ 0.0001) anal fistulas, secondary tracts ( p ¼ 0.041), history of previous abscess
drainage ( p ¼ 0.0001), seton placement ( p ¼ 0.008), and patients with postoperative
continence impairment ( p ¼ 0.0001) assessed with univariate analysis of factors
influencing this outcome. De novo postoperative continence impairment was the
only factor associated with a lower satisfaction rate in multivariate analysis
( p ¼ 0.0001).
The most recent reviews on fistula reported a particularly high recurrence risk
after anal fistula surgery in in flammatory bowel diseases, complex fistulas, and
recurrent fistulas. In these cases the fistula tract course must be carefully evaluated.
Even if Goodsall’s rule represent a good approximation, only the evaluation under
anesthesia and exams such as endoanal ultrasound with/without contrast or pelvic
magnetic resonance can clear ly highlight the anal fistula tract course and then
minimizing the recurrence rate.
278 P. Campennı`et al.
9 Discussion
Management of anal fistula remains challenging, with continuously emerging surgical techniques hampering the development of a robust treatment algorithm. To
complicate matters furt her, the quality of publications in the literature is extremely
variable, with many studies having limited follow-up or being too small in size for
robust assessment of clinical endpoints. Heterogeneity in outcome measures hampers meta-analysis. Controversies in the published guidelines can be partly explained
by the fact that some of them have become outdated because new medical and
surgical therapies have been introduced. Moreover, geographic differences also
exist: for this reason in 2019 we proposed a survey aimed to assess crucial elements
in surgeons’ evaluation and treatment of perianal abscess and anal fistula, and to
capture key demographic information about the respondents (Ratto et al. 2019).
The survey, namely, International Survey on Technical Aspects of Anal Fistula
Surgery, consisting of a 74-item questionnaire, exploring diagnostic and surgical
techniques, was designed and proposed to surgeons worldwide using an online
platform. Respondents were mostly men (82%), 40 years of age (64%), colorectal
surgeons (84%) at consultant level (84%), practicing in academic (53%), or
non-academic teaching (30%) hospitals. The 39% of surgeons that responded to
survey came from North America and 10% came from South America, 35% from
Europe, 12% from Asia, 3% from Australia and New Zealand, and only 0.4% from
Africa, for a total of 66 countries involved.
Among the imaging modalities used to assess anal fistula, our data confirm that
most surgeons consider endoanal ultrasound as an effective exam in the assessment
of anal fistula, a significant proportion (nearly 30%) of respondents rated this test as
“not at all useful” in any type of fistula. Among surgeons using MRI preoperatively,
the main indications were recurrent (88%) and primary (49%) complex anal fistulas,
and recurrent simple anal fistulas (32%). Similarly, among EAUS users, the main
indications were recurrent (37%) and primary (35%) complex anal fistulas, and
recurrent simple anal fistulas (23%). Only a minority of surgeons stated that they
would use MRI (5%) and EAUS (15%) for any type of anal fistula.
Fistulotomy and fistulectomy were the most frequently performed operations,
with over 40% of respondents carrying out more than 20 procedures per year.
Overall, 82% of surgeons considered fistulotomy as the gold standard treatment
only for simple fistulas, and 13% for most anal fistulas. In the latter group, Europeans
and surgeons practicing in non-teaching hospitals more commonly used this
approach compared to Americans [OR 2.38, 95% confidence interval (CI) 1.18–
4.79; p ¼ 0.015] and surgeons from academic centers (OR 2.31; 95% CI 1.13–4.49;
p ¼ 0.021), respectively.
During fistulotomy for transphincteric fistula, in the absence of preexisting
incontinence, surgeons would safely sacrifice up to a median of 25% (interquartile
range 16–30%) of the external anal sphincter, with only 21% of respondents making
no gender distinction. Conversely, a significant proportion (51%) of surgeons would
never cut the external sphincter in females with anterior fistula, while another 22%
surgeons would never cut at all in female patients.
17 Fistulotomy 279
Less than half of the respondents routinely performed either marsupialization or
immediate sphincter reconstruction (primary sphincteroplasty) after fistulotomy
for intersphincteric (32% and 9%, respectively) and transphincteric fistulas (24%
and 19%).
A significant proportion of respondents stated their own recurrence rate was 5%
or below after fistulotomy (61%), fistulectomy (29%), and therapeutic seton (29%)
for cryptoglandular anal fistula.
Declared rates of minor and major fecal incontinence were globally low, with
better outcomes after sphincter-preserving procedures compared to fistulotomy.
However, only 4% of surgeons derived such rates from their own published work.
Furthermore, less than half of respondents (42%) regularly used validated questionnaires, while 11% of them did not routinely asses s incontinence preoperatively.
Compared to Europeans and Americans, surgeons from the rest of the world were
less likely to use validated questionnaires (OR 0.54, CI 0.31–0.96; p ¼ 0.036) as
well as those practicing in nonacademic teaching (OR 0.61, CI 0.40–0.94;
p ¼ 0.025) and non-teaching hospitals (OR 0.52, CI 0.30–0.88; p ¼ 0.016) com-
pared to those from academic centers.
The vast majority of surgeons (82%) considered fistulotomy the gold standard of
treatment for simple fistula. On the other hand, a significant proportion (51%) of
surgeons would never cut the external sphincter in females with anterior fi stula,
while another 22% surgeons would never cut any muscle at all in female patients.
This is in line with the Association of Coloproctology of Great Britain and Ireland
(ACPGBI) recommendation that fistulotomy results in a reliable cure with good
patient satisfaction, where 2 cm of proximal muscle remains intact.
These data are corroborated by FISSIT study (Litta et al. 2021) that evaluated the
trend of surgical treatment in Italy over the last 15 years. It was a multicenter
retrospective observational study of patients affected by anal fistulas of
cryptoglandular origin who underwent surgery between January 2003 and December
2017. Any Italian center in which at least 30 surgeries/year for anal fistulas were
performed was able to join the study.
Twenty Italian centers joined the study, with an equal geographic distribution: six
centers were from northern, seven from central, and seven from southern regions. A
total of 9536 patients affected by cryptoglandular anal fistulas (5520 simple fistulas;
4016 complex fistulas) underwent surgery between January 2003 and December
2017 and entered the study. The mean number of patients treated in each center was
476.8 (range, 79–1218 patients). The most adopted technique, both for simple and
complex fistulas, was fistulotomy/fistulectomy (53.6%), and in 10.3% of cases
fistulotomy with immediate sphincter recons truction was performed, with a similar
adoption rate between simple and complex fistulas. The adoption of only
fistulectomy/fistulotomy significantly decreased over the years of the study
(slope ¼1.28, p < 0.0005, R2¼ 0.695), while the addition of a sphincter
reconstruction to the fistulotomy was more frequently used over time (slope ¼ 1.03,
p < 0.0005, R
2
¼ 0.805).
It could be inferred that the surgeons’ choice has been conditioned by the risk of
further anal continence impairment more than by the potential of cure, particularly in
280 P. Campennı`et al.
complex fistulas. Therefore, some surgeons have appreciated the possibility of
minimizing the risk of continence impairments (due to fistula lay-open) by immediate sphincter repair. This is confirmed by the significant increase in its adoption rate
for all types of fistula.
The assessment of healing rates obtained by different procedures showed that in
both simple and complex fistulas, traditional surgical techniques requiring
fistulotomy/fistulectomy achieved the highest cure rates; these data are consistent
with those in the available literature.
Data from FISSIT study seem to demonstrate good adherence to the European
guidelines, mainly concerning the use of fistulotomy in simple fistulas; on the other
hand, approximately one-third of the study patients with complex fistulas have been
treated with this sphincter-cutting procedure. In accordance with the guidelines, the
use of “cutting setons“has been reduced in Italy over time, especially for complex
fistulas; however, approximately 10% of patients with simple fistulas have been
treated in this way even in the last years of this study.
The adoption of a flap-construction, fistulotomy/fistulectomy and loose seton was
the prevalent preference at the beginning of the study period and remained that at the
end but with the rates almost halved.
The overall healing rate for complex fistulas was 69.0%. Among the procedures,
fistulotomy/fistulectomy, with or without sphincter reconstruction, achieved the
highest cure rates, again with a statistically significant difference between
sphincter-cutting (81.1%) and sphincter-sparing (61.4%) interventions ( p¼0.001).
Same issue regarding continence impairment after fistulotomy must be consid-
ered. Some studies suggest using preoperative anorectal manometry to evaluate
baseline anorectal function. Chang and Lin (2003) analyzed 45 patients with low
intersphincteric fistula with anorectal manometry performed at baseline and at least
6 months after surgery. They found that maximum anal resting pressure significantly
decreased, and a lower preoperative anal resting pressure was the only independent
predictive factor of postoperative continence disturbances. Similarly, Toyonaga et al.
(2007) recommended avoiding a fistulotomy in patients with intersphincteric fistulas
and with a preoperative low anal squeeze pressure at the anorectal manometry.
Therefore, a sphincter-sparing procedure in this kind of patient could be advisable.
A technical variation of lay-open fistulotomy to reduce postoperative fecal incontinence seems to be immediate sphincter reconstruction, both for simple and complex
fistulas.
A systematic review of literature conducted by Litta F et al. (2021) show s that the
surgical treatment of simple anal fistulas with sphincter-cutting procedures provides
excellent cure rates, even if postoperative fecal incontinence is not a negligible risk,
so a sphincter-sparing procedure could be useful in selected patients.
The review included prospective, retrospective, observational studies, and ran-
domized clinical trials on simple anal fistula treatment from 1990 to 2020. A total of
4883 patients (weighted average age: 41.3 years; M:F ratio 6:1) underwent a
sphincter-cutting procedure, which was usually fistulotomy or fistulectomy. Main
technical variations reported were marsupialization or primary sphincteroplasty.
Sphincter-sparing techniques were adopted to treat 602 patients (weighted average
age: 36.2 years; M:F ratio 4:1) with a simple anal fistula. After a wei ghted average
17 Fistulotomy 281
follow-up of 14.7 (1–77) months, the weighted mean success rate after a sphinctercutting procedure was 93.7% (61.0–100%), while any postoperative continence
impairment was reported in 12.7% of patients (0–45.7%). Overall, sphincter-sparing
techniques reached a weighted average success rate of 77.7% (25.0–100%) after a
weighted average follow-up of 13.2 (2.3–71.0) months.
Patients’ satisfaction after fistulotomy for a simple anal fistula was analyzed by
Abramowitz L et al. (2016) and Saber A (2016). They stated that the satisfaction was
high or very high in 86.4% and 90.6% of patients, respectively.
Another retrospective article (Visscher et al. 2015) reported that the postoperative
onset of fecal incontinence reduced patients’ QoL and satisfaction. Also the recurrence of the disease had a negative impact on QoL as evaluated in a recent
prospective study (Vander Mijnsbrugge et al. 2019).
While in a prospective study (Jayarajah et al. 2017) fecal incontinence had no
significant effect on patients’ QoL and satisfaction.
10 Conclusion
Fistulotomy provides excellent cure rates, even if a certain morbidity should be
expected. Postoperative continence impairment is not a negligible risk, which could
have a detrimental effect on both patients’ QoL and satisfaction, and it should be
discussed during counseling. Data from literature seem suggest that patients suitable
for FIPS could be those with either middle-low transphincteric or intersphincteric
fistulas. Indications for FIPS should be better evaluated in future trials to establish its
role in an ideal treatment algorithm for the management of anal fistula.
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