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85
© Springer Nature Switzerland AG 2019
N. Hyman et al. (eds.), Mastery of IBD Surgery,
https://doi.org/10.1007/978-3-030-16755-4_10
C. Atallah · M. Mutch (*)
Section of Colon and Rectal Surgery, Division of General Surgery, Department of Surgery,
Washington University School of Medicine at Barnes Jewish Hospital, St. Louis, MO, USA
e-mail: mutchm@wustl.edu
10
Management ofSimple Anoperineal
Fistulas
ChadyAtallah andMatthewMutch
Introduction
Patients with anoperineal Crohn’s disease (CD) are often challenging to treat. They
frequently require a combination of medical and surgical treatment to control their
disease. More than one-third of patients with Crohn’s disease will at some point
develop perianal disease, and some patients will have it as their presenting symptom
several years before a diagnosis of Crohn’s disease is made [1]. Anal stulas are
particularly difcult to treat in patients with Crohn’s disease due to the pathophysi-
ologic characteristics of the disease, the high likelihood of recurrence, and the
potential for surgical complications [2].
Although medical management of Crohn’s disease is crucial to achieve long-
term control of perianal disease, surgery is sometimes required as a primary treat-
ment or as an adjunct to other treatments. It is usually reserved for patients who
present with active infection or sepsis, or to treat complex or non-healing perianal
stulas. The American Society of Colon and Rectal Surgeons currently recom-
mends no surgical treatment for asymptomatic stulas, while simple low anal stu-
las can be safely treated with stulotomy [3, 4].
In this chapter, we will address the management of simple perianal stulas
(including supercial, intersphincteric, and low transsphincteric that cross 30% or
less of the external anal sphincter), comparing surgical management to medical
management, specically biologics and immunomodulators. We will review the rel-
evant literature, looking at the success rate of treatment, as well as the complications
from surgery including incontinence.
86
Search Strategy
We performed our literature review using a Medline and Pubmed search for pub-
lications in the English language addressing the surgical and medical manage-
ment of simple perianal Crohn’s disease in the last 2 decades. We included studies
published between January 1995 and June 2018, and we used the following search
terms: “Crohn’s,” “perianal disease,” “simple stula,” “stula-in-ano,” “stulot-
omy,” “seton,” “medical management,” “iniximab,” “adalimumab,” “tacroli-
mus,” “immunomodulator,” “biologic,” “outcome,” “healing rate,” “recurrence,”
incontinence.”
We then looked at the reference section of each article to identify additional stud-
ies relevant to our review. We included randomized trials, retrospective and prospec-
tive studies. We included articles looking specically at simple perianal stulas, and
excluded studies addressing the management of complex perianal disease and rec-
tovaginal stulas (Table10.1).
Results
Over the past few decades, several studies have been published looking at the man-
agement of perianal stulas in patients with Crohn’s disease. Only a few of these
studies however reported separate outcomes for simple stulas, and even fewer only
included simple stulas in their study population. Those were all included in
Table10.2. The surgical management of complex anal stulas in Crohn’s disease
will be discussed in a different chapter.
The earlier studies were mostly retrospective reviews of patients with Crohn’s
disease presenting with simple anal stulas, who were surgically treated. Halme
performed a 20-year review of Crohn’s disease patients showing 100% healing rate
following stulotomy, compared to 50% following seton placement for simple s-
tulas [5]. In a similar review with a higher number of patients, Scott described
more comparable healing rates between the two techniques (81% vs. 85%) [6].
Both studies reported some degree of anal incontinence in about 20% of patients
after stulotomy [5, 6]. Around that same time, three retrospective reviews looking
at stulotomy in Crohn’s disease patients also reported similar outcomes.
Williamson, in a 20-year review, reported a healing rate of 85% in 22 patients with
Table 10.1 PICO question
P (Patients)
I (Intervention) C (Comparator)
O (Outcomes)
Crohn’s disease
patients with
simple
stula-in-ano
Surgical management
(stulotomy, seton,
stula plug/glue)
Medical management
(antibiotics, iniximab,
tacrolimus)
Healing rates and
recurrence,
complications
(incontinence)
C. Atallah and M. Mutch
87
Table 10.2 Studies evaluating management of simple anal stulas in Crohn’s disease patients
First author
(year)
Patients
(N)
Study
design
Treatment
modality
Healing
rate
Incontinence
(post-operative
complication)
Quality
of evidence
Halme
(1995)
18 R Fistulotomy vs.
seton
100% vs.
50%
20% (to some
degree) vs. 0%
Low
Scott (1996) 54 R Fistulotomy vs.
seton
81% vs.
85%
19% vs. 0% Moderate
Williamson
(1995)
22 R Fistulotomy 85% 13% Low
Sangwan
(1996)
47 R Fistulotomy N/A 0% Low
Platell
(1996)
34 R Fistulotomy 91% 0% Low
Michelassi
(2000)
33 PO Fistulotomy 27/33
(82%)
2/33 (12%) Moderate
Van
Koperen
(2009)
28 PO Fistulotomy 82% >50% (to some
degree)
Low
Witte
(2007)
11 PO Fibrin glue 54% N/A Low
Grimaud
(2010)
41 RCT Fibrin glue vs.
observation
50% vs.
18%
N/A High
Senéjoux
(2016)
78 RCT Fibrin plug after
seton vs. seton
alone
30% vs.
25%
N/A High
Lowry
(1999)
22 R Oral tacrolimus,
and AZA or
6-MP
7
complete
response
(32%)
4 partial
response
(18%)
N/A Low
Thia (2009) 25 RCT Ciprooxacin
vs.
metronidazole
vs placebo
40% vs
14.3% vs
12.5%
N/A Moderate
Topstad
(2003)
21 R Seton followed
by iniximab
67%
complete
response
19%
partial
response
0% Low
Park (2017) 20 R Fistulotomy or
seton followed
by iniximab
75% 0% Low
PO prospective, R retrospective, RCT randomized controlled trial, AZA azathioprine, MP
mercaptopurine
10 Management ofSimple Anoperineal Fistulas
88
low stulas [7]. Postoperative incontinence was observed in 13% of patients, but
that included cases with complex stulas [7]. Sangwan reported no postoperative
incontinence in his series of 47 patients with anal stulas, 35 of whom underwent
stulotomy [8]. Platell showed an excellent healing rate of 91% of the 34 patients
with simple stulas [9]. More recently, Michelassi prospectively recorded out-
comes of 224 patients with Crohn’s disease and perianal disease, 33 of whom had
simple stulas, over a period of 15 years. They reported a healing rate of 82%, with
incontinence in two of the patients (12%) [10]. Similarly, van Koperen prospec-
tively studied surgical outcomes following stulotomy. Out of the 28 patients
included in his series, 23 demonstrated complete resolution and healing (82%)
[11]. More than one-half of the patients in that series however, reported at least
some degree of fecal incontinence [11].
There have also been a few studies looking at the use of brin and collagen prod-
ucts in the treatment of simple anal stulas in patients with Crohn’s disease. Witte
prospectively looked at the outcomes of patients undergoing brin sealant treatment
of anal stulas. The subset of patients with Crohn’s disease had a healing rate of
54%, which was similar to the healing rate of patients with simple stulas and no
Crohn’s disease [12]. In a multi-center randomized controlled trial (RCT), Grimaud
compared outcomes of brin sealant treatment compared to no treatment for patients
with perianal Crohn’s disease. They found a signicant increase in healing rate from
18% to 50% in the group of patients with simple stulas [13]. In another RCT,
Senéjoux looked at the use of collagen plug following seton removal in Crohn’s
disease patients. In the subset of patients with simple stulas, the healing rate was
30% for patients treated with the plug compared to 25% for patients who merely
had their seton removed with no further surgical treatment [14]; this difference was
not statistically signicant.
Lastly, some authors have reported outcomes with different medical therapies
used in Crohn’s disease patients with simple stulas. Lowry retrospectively
reviewed the role of oral tacrolimus plus azathioprine or 6-mercaptopurine to treat
22 patients with low simple stulas; 7 of these patients had complete response, and
4 had partial response (32% and 18% respectively) [15]. Thia studied antibiotic
treatment in an RCT, where Crohn’s disease patients with simple stulas were
treated with either ciprooxacin, metronidazole, or placebo. Healing of the stula
was achieved in 40% of patients treated with ciprooxacin, compared to 14.3% of
those managed with metronidazole, and 12.5% for those receiving placebo [16].
However the number of patients was too low in each group, and the study was
underpowered to show a signicant difference. Topstad retrospectively reviewed
22 patients treated with iniximab, 14 of those underwent seton placement before
treatment. The complete healing rate was 67%, with 19% showing partial response
[17]. No incontinence was reported in that group. Another retrospective study by
Park looked at patients managed with iniximab following either stulotomy or
seton placement. The subset of patients with simple stulas experienced a 75%
healing rate after induction, and 100% with maintenance therapy [18]; no inconti-
nence was reported in that selected group.
C. Atallah and M. Mutch
89
Recommendations Based ontheData
To summarize these data, the rst seven studies looking at outcomes following s-
tulotomy consistently revealed excellent rates of healing that ranged from 82% to
100% [5–11]. Furthermore, the incontinence rate following stulotomy was 0% to
20%, except for one report that showed some degree of incontinence in more than
one-half of the patients. This wide range and difference in incontinence rates may
reect differences in the way incontinence was assessed in these patients. But over-
all, the trend is toward excellent healing rates following stulotomy for low simple
stulas with acceptable risk for incontinence. Non-cutting seton placement was
associated with slightly lower healing rates ranging from 50% to 85% in two of the
studies but no incontinence was reported [5, 6]. In comparison, the studies that
examined the role for brin and collagen products as primary treatment of these
patients, showed that these products did not achieve healing rates comparable to
stulotomy, and ranged from 30% to 54% [12–14]. Medical management without
surgical therapy achieved even lower healing rates [15, 16]. However, when used in
combination with surgery, iniximab was shown in two separate studies to provide
healing rates ranging from 67% to 75% [17, 18].
Based on these available data, we recommend that patients with Crohn’s disease
presenting with symptomatic simple anal stulas undergo stulotomy as primary
treatment. If there are concerns about signicant sphincter muscle involvement or
risk for incontinence with stulotomy, seton placement is a good alternative.
Iniximab or other biologics should not be used alone in the treatment of simple
anal stulas, but rather in combination with surgical treatment.
Personal View
Our experience with Crohn’s disease patients presenting with perianal disease is
consistent with the reviewed published data. Patients who have well controlled
disease and present with a simple anal stula are best treated with an examination
under anesthesia, and when no or minimal external sphincter muscle is involved,
we perform a stulotomy if we believe their risk for incontinence from stulot-
omy is low. The majority of these patients will have complete resolution of their
symptoms. However, if there is any concern about signicant sphincter involve-
ment or active proctitis, we usually place non-cutting setons and optimize medical
management. These patients tend to have recurrences and several stulas, and we
accordingly avoid dividing any sphincter muscle. Seton placement is a valid and
effective alternative to stulotomy, and in our experience patients tolerate this
approach very well.
Most of the recently published data about perianal Crohn’s disease mainly
focuses on the management of complex stulas, and on new medical treatments.
The optimal surgical management of simple stulas has been established for
decades. These older published studies all report good outcomes following
10 Management ofSimple Anoperineal Fistulas
90
stulotomy for Crohn’s disease patients with simple stulas. This is why it is crucial
for surgeons treating these patients to know how to assess the disease, and to offer
the appropriate surgical treatment.
1. Patients with Crohn’s disease presenting with symptomatic simple anal s-
tulas should undergo stulotomy as primary treatment.
2. If there are concerns about sphincter muscle involvement, seton placement
is a good alternative.
References
1. Eglinton TW, Barclay ML, Gearry RB, etal. The spectrum of perianal Crohn’s disease in a
population-based cohort. Dis Colon Rectum 2012;55(7):773-7.
2. Tozer PJ, Lung P, Lobo AJ, etal. Review article: pathogenesis of Crohn’s perianal stula-
understanding factors impacting on success and failure of treatment strategies. Aliment
Pharmacol Ther. 2018;48(3):260–9.
3. Steele SR, Kumar R, Feingold DL, etal. Practice parameters for the management of perianal
abscess and stula-in-ano. Dis Colon Rectum. 2011;54(12):1465–74.
4. Vogel JD, Johnson EK, Morris AM, et al. Clinical practice guideline for the manage-
ment of anorectal abscess, stula-in-ano, and rectovaginal stula. Dis Colon Rectum.
2016;59(12):1117–33.
5. Halme L, Sainio AP.Factors related to frequency, type, and outcome of anal stulas in Crohn’s
disease. Dis Colon Rectum. 1995;38(1):55–9.
6. Scott HJ, Northover JM.Evaluation of surgery for perianal Crohn’s stulas. Dis Colon Rectum.
1996;39(9):1039–43.
7. Williamson PR, Hellinger MD, Larach SW, Ferrara A. Twenty-year review of the surgical
management of perianal Crohn’s disease. Dis Colon Rectum. 1995;38(4):389–92.
8. Sangwan YP, Schoetz DJ Jr, Murray JJ, etal. Perianal Crohn’s disease. Results of local sur-
gical treatment. Dis Colon Rectum. 1996;39(5):529–35.
9. Platell C, Mackay J, Collopy B, etal. Anal pathology in patients with Crohn’s disease. Aust N
Z J Surg. 1996;66(1):5–9.
10. Michelassi F, Melis M, Rubin M, Hurst RD.Surgical treatment of anorectal complications in
Crohn’s disease. Surgery. 2000;128(4):597–603.
11. van Koperen PJ, Saruddin F, Bemelman WA, Slors JF.Outcome of surgical treatment for
stula in ano in Crohn’s disease. Br J Surg. 2009;96(6):675–9.
12. Witte ME, Klaase JM, Gerritsen JJ, Kummer EW.Fibrin glue treatment for simple and com-
plex anal stulas. Hepatogastroenterology. 2007;54(76):1071–3.
13. Grimaud JC, Munoz-Bongrand N, Siproudhis L, etal. Fibrin glue is effective healing perianal
stulas in patients with Crohn’s disease. Gastroenterology. 2010;138(7):2275–81.
14. Senéjoux A, Siproudhis L, Abramowitz L, et al. Fistula plug in stulising ano-perineal
Crohn’s disease: a randomised controlled trial. J Crohns Colitis. 2016;10(2):141–8. https://
doi.org/10.1093/ecco-jcc/jjv162.
15. Lowry PW, Weaver AL, Tremaine WJ, Sandborn WJ.Combination therapy with oral tacroli-
mus (FK506) and azathioprine or 6-mercaptopurine for treatment-refractory Crohn’s disease
perianal stulae. Inamm Bowel Dis. 1999;5(4):239–45.
16. Thia KT, Mahadevan U, Feagan BG, etal. Ciprooxacin or metronidazole for the treatment
of perianal stulas in patients with Crohn’s disease: a randomized, double-blind, placebo-
controlled pilot study. Inamm Bowel Dis. 2009;15(1):17–24.
C. Atallah and M. Mutch
91
17. Topstad DR, Panaccione R, Heine JA, etal. Combined seton placement, iniximab infusion,
and maintenance immunosuppressives improve healing rate in stulizing anorectal Crohn’s
disease: a single center experience. Dis Colon Rectum. 2003;46(5):577–83.
18. Park EJ, Song KH, Baik SH, etal. The efcacy of iniximab combined with surgical treatment
of stulizing perianal Crohn’s disease: comparative analysis according to stula subtypes.
Asian J Surg. 2018;41(5):438–47.
10 Management ofSimple Anoperineal Fistulas
93
© Springer Nature Switzerland AG 2019
N. Hyman et al. (eds.), Mastery of IBD Surgery,
https://doi.org/10.1007/978-3-030-16755-4_11
S. Khaitov (*) · A. Ofshteyn
Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA
e-mail: sergey.khaitov@mountsinai.org
11
Management ofSevere Anoperineal
Disease
SergeyKhaitov andAsyaOfshteyn
Introduction
Perianal involvement can occur in up to 42% of patients with Crohn’s disease and
has the potential to cause signicant life impairment [1, 2]. Close to 90% of patients
with anoperineal Crohn’s disease require surgical intervention at some point in their
lifetime [3, 4], and up to 38% of patients with complex perianal stulas undergo
fecal stream diversion [5, 6]. This chapter focuses on surgical treatment of severe
perianal Crohn’s disease (pCD) with a goal to compare seton placement with tem-
porary fecal diversion (Table11.1).
No established denition exists in the literature for what constitutes severe peri-
anal Crohn’s disease. Traditionally, stulas are classied as simple or complex s-
tulas by criteria described by the American Gastroenterological Association [7].
However, anatomic complexity is only one of the many factors that affects patient
experience. The Perianal Disease Activity Index (PDAI) is a disease activity score
that uses ve sequelae to categorize severity of perianal disease, including levels of
discharge, pain interfering with day-to-day activity, restriction of sexual activity,
degree of induration, and type of disease [8]. Although useful for clinical trials, the
PDAI and other measurements of perianal Crohn’s disease activity such as stula
drainage assessment are not routinely used in clinical practice. Additionally, there is
Table 11.1 PICO question
Patients
Intervention Comparator
Outcome
Patients with severe perianal
Crohn’s disease
Fecal
diversion
Multiple
setons
Long-term stoma avoidance,
quality of life
94
no PDAI threshold for mild versus severe perianal Crohn’s disease. Therefore, most
gastroenterologists and surgeons focus on individual patient-reported experience
and global clinical judgment to dene severe disease [9]. For the purposes of this
chapter, we have dened severe perianal Crohn’s disease as anoperianal involve-
ment with: (1) infectious complications requiring frequent surgical intervention; (2)
persistent discomfort and incontinence signicantly affecting quality of life.
Search Strategy
We performed a comprehensive search of the Medline, Pubmed, Web of Science,
and Cochrane databases using the following search terms: ‘Crohn’s disease’ and
(‘perianal’ OR ‘perineal’ OR ‘anoperineal’) and (‘management’ OR ‘seton’ OR
‘diversion’ OR ‘stoma’ OR ‘ostomy’). The search was limited to peer-reviewed
English language publications between 1950 and 2018. Any relevant studies found
in reference sections of pertinent articles were also included. All abstracts were
reviewed and papers evaluating outcomes of either fecal diversion or multiple seton
placement were selected. We sought to include randomized, observational, prospec-
tive and retrospective studies, but only retrospective and prospective observational
studies were available. These are represented in the Table11.2.
Results
No studies directly compare fecal diversion with seton management in the same
patient population. Most of the literature consists of retrospective chart and data-
base reviews that describe a varied patient population with perianal Crohn’s disease,
a wide range of surgical interventions, and a plethora of outcomes (Table11.2). For
this review, all patients had anoperineal Crohn’s disease including simple and com-
plex anorectal stulas, ano- or rectovaginal stulas, and differing levels of proctitis
or other proximal disease. Surgical interventions were chosen based entirely on the
discretion of the treating surgeon and consisted of local therapy including: loose
seton placement with or without incision and drainage; denitive treatments includ-
ing cutting setons, stulotomy, stula plug, stula glue, advancement ap, sphinc-
terotomy, sphincteroplasty, ssurectomy, and soft tissue aps (local surgical
treatment outcomes described in Table11.2), and; major operations including loop
ileostomy, small or large bowel resections, and proctectomy (diversion outcomes
described in Table11.3).
When reported, concurrent medical management was similarly diverse. Some
patients received only antibiotics, while others also received immunosuppressants
(e.g., methotrexate, thiopurines). Patients enrolled in more recent studies received
biologic agents, most commonly iniximab or adalimumab but at different dosages
and durations of treatment (combined biologic agent and seton outcomes described
in Table11.4). Reported outcomes also wildly differed, including anoperineal heal-
ing, initial versus lasting perianal Crohn’s disease improvement, patient
S. Khaitov and A. Ofshteyn
95
Table 11.2 Studies describing outcomes of seton placement or diversion with and without medical therapy for perianal Crohn’s disease
First author (year)
Patients studied Intervention
Study
design N Outcome
Quality
of evidence
van Dongen (1986)
[10]
Patients with pCD No treatment, local surgery,
diversion, proctectomy
R 55 13 no treatment (4 healed), 28 local surgery (2
with setons, 22 healed, 2 proctectomy), 9
diversion (4 healed, 2 stomas closed), 5
proctectomy (2 persisted)
Very low
Bernard (1986)
[11]
Patients with pCD I&D ± seton, stulotomy,
proctectomy
R 102 57% I&D ± seton required stulotomy; primary
stulotomy for abscess 71% healed; primary
stulotomy for chronic stula 60% healing; 12%
proctectomy
Very low
Radcliffe (1988)
[12]
Women with pCD
and anovaginal or
rectovaginal stula
Medical management,
stulotomy or I&D, repair of
stula, proctectomy
R 90 12 medical management, 12 stulotomy or I&D,
12 stula repair (8 cured, 1 symptomatic, 3
proctectomy), 8 diverted, 46 proctectomy
Very low
Fry (1989) [13] Patients septic pCD Perianal intervention,
diversion, proctectomy
R 73 After 4.6years f/u:
38 healed and 17 acceptable condition after one
or more EUA; 9 healed with diversion, 9
required proctectomy
Very low
Fry (1989) [13] Patients with pCD Seton or stulotomy R 73 Mean follow up 4.6years. 38 healed after one or
more local treatment, 17 incompletely healed, 9
healed after diversion, 9 proctectomy
Very low
Williams (1991)
[14]
Patients with high
anal stula (23
with pCD)
Long-term seton R 23 9 recurred, 3 proctectomy Very low
Scott (1992) [15] Women with pCD
± RVF
Local surgery, diversion,
proctectomy
R 67 13/38 women with anorectal stula got diversion
or proctectomy compared to 18/29 women with
RVF
Very low
(continued)
11 Management ofSevere Anoperineal Disease