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4 Anorectal Fistula
shown in this review to support any one form of treatment” [ 42 ] . The authors
pointed out that even widely practiced techniques, like oversewing of the internal
opening, have not been studied in detail. They went on to make a plea for well-
powered, well-conducted randomized controlled trials comparing various modes of
treatment of fi stula in ano. Their review highlighted some possible comparisons
such as conventional fi stulotomy vs. fi stulectomy, conventional fi stulotomy vs.
seton alone, and conventional fi stulotomy vs. fi brin glue. Newer techniques such as
the anal fi stula plug and ligation of the intersphincteric tract (LIFT) have been
described, but have not been compared to established surgical procedures. The use
of stem cells and collagen matrixes also needs further study and comparison with
existing techniques.
The lack of clarity from these reviews frustrates the surgeon treating anal fi stulas.
The treatment of both hemorrhoids and anal fi ssure has been very nearly defi nitively
clarifi ed in Cochrane reviews as the studies needed to resolve seminal issues have
been done, and in many cases of suffi cient quality to allow conclusions to be drawn
in review. Yet, the most historic and perhaps most complex of all colorectal diseases
does not enjoy the same status. Additional RCTs have been published that are not
included in either of these reviews (Table
4.2 ).
A number of comments are worth making on these trials:
Shukla lost 40% of his patients in follow-up, so, though the population is large,
it cannot be considered to be an RCT but simply a case series [ 43 ] . Belmonte-
Montes et al. missed a golden opportunity in what appears to be a well-con-
structed RCT comparing fi stulotomy to fi stulectomy, a very important topic. But
the only outcome provided was ultrasonic fi ndings of the sphincter [ 44 ] .
Zimmerman et al. demonstrated that there are things we do during surgery other
than sphincter division that may have deleterious effects on continence [ 45 ] .
Singer et al. performed one of three fi brin glue studies with additives to the glue,
in this case, antibiotics. In addition, suture closure of the internal opening was
added as a variable. There was no “gold standard” comparator. Healing rate was
poor throughout the study, and no advantage was found related to antibiotic inclu-
sion or rectal closure [ 46 ] . Chen et al. in an abstract described an RCT of an
intriguing procedure which sounds very much like the LIFT, 2 years before the
fi rst publication of the LIFT, for which RCTs have yet to be published [ 47 ] . Perez
et al. attempted to address postfi stulotomy continence issues by immediate
sphincter repair but found equivalent postoperative incontinence in both groups
[ 48 ] . Gustafsson and Graf addressed the idea of infection causing fl ap failure by
implanting gentamicin–collagen beneath the fl ap with no benefi t [ 49 ] . Garcia-
Olmo et al. described another fi brin glue additive, in this case autologous stem
cells, with signifi cant benefi t. Further studies of this technique are eagerly awaited
[ 50 ] . Hammond et al. described yet another fi brin glue additive, in this case an
emulsion of a similar collagen matrix to that used in the fi stula plug. There is a
suggestion of benefi t, but the study is small [ 51 ] . Grimaud et al. compared fi brin
glue to no therapy in patients with Crohn’s fi stulas. It is perhaps the only placebo-
controlled trial related to anal fi stula and as such demonstrates a benefi t of glue in
achieving “remission,” an outcome in the gastroenterology literature that the
58
R. Nelson
authors believe does not mean the same thing as cure [ 52 ] . Khafagy et al. studied
rectal fl ap closure of the internal opening. The fl aps were composed of either
mucosa alone or mucosa and muscularis (i.e., internal sphincter). Full thickness
fl aps achieved insignifi cantly higher ( p = 0.068) healing but at a risk in some
(2/20) of incontinence [
53 ] .
One nonrandomized report having to do with anorectal abscess and fi stula in
very small infants is of some interest. Infants and smaller children with anal fi ssure
are treated conservatively and rarely fi nd their way in the operating room. This same
conservatism was applied to small babies with abscess and fi stula who were treated
with drainage of abscesses or expectant treatment of established fi stulas. Of 18
patients they examined, all 18 had resolution of their fi stulas spontaneously without
surgical correction [ 54 ] . This suggests that fi stulas in infants are a very different
disease than fi stulas in adults [ 55 ] .
4.9 Loose Ends
Seton placement, that is, a stitch placed through the fi stula track which is then either
gradually tightened or left loosely in place and fi stula divided in multiple stages,
was fi rst proposed by Hippocrates over 2,500 years ago. It is still common practice
in both forms [ 56 ] , but amazingly its effi cacy remains unproven and there is no
uniform method of seton usage.
It would be interesting to revisit the rather interesting concept of primary abscess
obliteration and closure. Early studies seem to favor this procedure. Its disappear-
ance is puzzling. It is possible that it might gain broader acceptance if a less punitive
suture technique were used.
The relative effi cacy and morbidity of fi stulectomy vs. fi stulotomy have not
been adequately resolved. We still do not know whether patients with abscess and
fi stula should have defi nitive treatment at the time of abscess drainage. While it is
possible that defi nitive treatment at the time of incision and drainage will result in
less likelihood of chronic fi stula formation, many patients would not have devel-
oped a fi stula and could have avoided fi stula surgery with the risk of diminished
anal control.
Newer procedures, such as closure of the internal opening of the fi stula with
either a mobilized fl ap of rectal mucosa or anoderm, the injection of fi brin glue,
collagen plug matrix, autologous stem cells, and LIFT all appear to be attractive
means of avoiding sphincter division in the treatment of fi stula. Measurable success
rates have been reported with these procedures. But their relative usefulness com-
pared to fi stulotomy in eradicating the fi stula, in preventing subsequent sepsis, and
preserving continence is unknown.
Lastly, the simplest procedure imaginable for anal fi stula has never been
described, much less investigated: simple or layered closure of the internal opening
alone? Of course, it is a part, or after early failures became a part, of other proce-
dures such as the fi stula plug, or LIFT.
59
4 Anorectal Fistula
4.10 What We Do Not Know
The biggest problem facing a surgeon when addressing a patient with anal fi stula is
how to eradicate the problem without causing incontinence. This was once thought
to be a minor problem. However, even some quite old publications demonstrate
substantial risk of incontinence after fi stulotomy, reaching as high as 55% for
patients with horseshoe abscesses [ 57 ] . If the real and clinically signifi cant preva-
lence of anal incontinence is as high as some reports suggest, it is a wonder that
operative procedures for anal fi stula have stood the test of time. Yet, it seems that the
vast majority of patients having fi stula surgery feel satisfi ed with their procedure. In
many reports of fi stula surgery, the reported rate of incontinence is zero. One recent
study showed that patients rarely voluntarily report incontinence to their surgeon.
However, when specifi cally asked if they were incontinent, 10% reported inconti-
nence after fi stula surgery. When the same patients were mailed a questionnaire, the
rate of reported incontinence shot up to 50% [ 58 ] . Clearly, something is wrong with
the way we assess postoperative continence in patients who are having anorectal
procedures in general and treatment of abscess and fi stula in particular. There is not
a “gold standard” for assessment of postoperative incontinence, which makes inter-
pretation of reported series diffi cult. What is needed is reporting of the relative risk
of incontinence, comparing several procedures in a properly conducted RCT. A
standard continence assessment instrument and, most importantly, a uniform timing
of continence assessment – well after wound healing – are needed in future studies.
Table 4.3 Anal fi stula trials registered on ClinicalTrials.gov.
RCT Country Intervention Comparator
Recruiting
Completed
Active
Terminated
+ USA LIFT Plug
R
− China Plug – R
− Saudi Arabia Plug – R
+ Germany Plug Rectal fl ap R
+ Sweden Plug Rectal fl ap R
− China Acellular dermal matrix – R
+ Egypt Thin fl ap Thick fl ap C
+ Italy Glue Seton T
− USA Plug – T
+ Turkey Antibiotic post-I&D No antibiotic R
+ Spain Autologous stem cells (ASC) + glue Glue C
+ Spain ASC + glue Glue A
+ USA Plug Cutting seton R
− Israel Prevalence of Crohn’s in patients
with anorectal disease
– R
+ USA and UK Topical metronidazole for Crohn’s
anorectal disease
– C
60
R. Nelson
Related to abscess and fi stula, a control group must constitute an accepted gold
standard. For abscess this would seem to be unroofi ng and packing, for fi stula,
simple fi stulotomy. There are new procedures proposed specifi cally to diminish the
risk of incontinence in patients with fi stula, but the usefulness of these procedures
has yet to be rigorously established.
4.11 Conclusions
Anal fi stula is a common condition. Fortunately, most patients have a simple fi stula,
which can be treated by fi stulotomy with only minor alteration in anal control and
acceptable recurrence rate. For a condition that has been around for centuries, there
is little hard scientifi c evidence to guide the surgeon as to the most appropriate treat-
ment, especially for more complex fi stulas. The situation is improving, and a num-
ber of randomized clinic trials are in progress around the world (Table 4.3 ).
Hopefully, results of these and future trials will place the treatment of this intriguing
condition on a more scientifi c footing.
Case Scenario Answers 1
(a) The history of a previous abscess makes an underlying fi stula very likely.
The history should establish whether there has been any likelihood of
sphincter damage, either from previous surgery or complicating vaginal
delivery. She has bouts of loose motions, and further enquiry should seek
to establish whether this is likely to be a functional problem or indicative
of underlying Crohn’s disease. Possible causes of diminished immunity
should be explored. These include diabetes, steroid treatment, chemo-
therapy, and HIV.
(b) The primary treatment should be incision and drainage of the abscess
through the most fl uctuant area, taking care to avoid the anal sphincters.
Key Points
Fistulas are common. •
Most arise from a preexisting abscess. •
Most abscesses present with pain. •
Diagnosis is clinical but may be aided by EAUS and/or MRI. •
Various treatment options exist, but the optimum method is unclear from •
current scientifi c evidence.
Surgical options are a balance between effi cacy and maintenance of •
continence.
61
4 Anorectal Fistula
Case Scenario Answers 2
(a) Initial assessment is made in the outpatient clinic. Careful inspection will
reveal other features of perianal Crohn’s disease, such as fi ssuring and
anal tags. If digital examination is possible, cavitating ulceration within
The abscess is likely to be superfi cial, but the surgeon should always be
alert to the possibility of a supralevator abscess, which should be drained
into the rectum. Pus should be sent for culture to identify the type of
organism, although as this is a recurrent abscess, it is unlikely to be a
simple cutaneous abscess.
(c) Antibiotics have little or no role in the management of most anal abscesses;
however, most patients present to hospital having had at least one course
of antibiotics from their general practitioner. Incision and adequate drain-
age is usually all that is required to resolve the acute infection. However,
there are circumstances where antibiotics are required. These include the
patient who is systemically unwell or where there is any suggestion of
necrotizing infection, where the patient has diminished immunity (diabe-
tes, HIV, chemotherapy, etc.), and where the patient has an implanted
prosthesis (e.g., prosthetic heart valve). Crohn’s disease is a special situ-
ation. For simple abscesses, antibiotics add little: for more complex sep-
sis, there is evidence that antibiotics (metronidazole or ciprofl oxacin)
improve things in the short to medium term.
(d) As this is a recurrent abscess and likely to have an underlying fi stula,
it is tempting to explore the abscess cavity to try and identify the fi s-
tula track. If found, this could be laid open if superfi cial, or drained
with a loose seton if deemed to be deeper. The issue is controversial,
although a number of studies report good results for immediate fi stu-
lotomy. However, caution should be exercised as it is often diffi cult to
assess how much sphincter is involved when the tissues are edema-
tous, and fi stulotomy does carry a risk of dividing a signifi cant quan-
tity of sphincter muscle, where an alternative surgical technique would
have been more appropriate. Secondly, identifying the track can be
diffi cult if the tissues are infl amed, and there is a risk of creating false
passages with injudicious probing. It is known that many abscesses
will heal without leaving a fi stula track, but in this case this is less
likely as the abscess is recurrent. Gentle exploration could be per-
formed and if the internal opening is readily identifi ed, a loose seton
could be inserted to maintain drainage and prevent a further abscess.
The fi stula could then be assessed fully when the acute infl ammation
had settled.
62
R. Nelson
the anal canal may be felt. Sigmoidoscopy and proctoscopy will provide
further information, but she may be too sore for such examination, in
which case an examination under anesthetic may be necessary. As regards
her fi stula, MRI is likely to be the most useful investigation because it is
likely to be a complex fi stula. Endoanal ultrasound will be less useful,
other than to identify the site of the internal opening and the depth of the
primary track.
(b) There are several therapeutic options for her anal fi stula. In the short
and medium term, antibiotics may improve her symptoms. Metronidazole
has an evidence base for its effectiveness, but ciprofl oxacin is a more
palatable alternative, especially as there is risk of neuropathy with pro-
longed use of metronidazole. There has been a school of thought that
advises against surgical treatment of Crohn’s anal fi stulas. However,
most surgeons would now advocate examination under anesthetic, par-
tial lay open of the fi stula and insertion of a draining seton as a safe and
effective means of controlling the patient’s symptoms. Sometimes a
permanent loose seton provides good long-term control of the symp-
toms. In certain situations, more aggressive treatment by fi stulotomy or
advancement fl ap repair is appropriate. Some success has been reported
after insertion of fi brin glue or collagen fi stula plug into Crohn’s fi stu-
las. Infl iximab has been shown to be effective in perianal fi stulas in
Crohn’s disease in a number of trials. However, it should be remem-
bered that the end point of most of these studies has been cessation of
discharge, rather than healing of the fi stula. Defunctioning the rectum
by colostomy or ileostomy may improve the acute suppuration, but it is
unusual that things improve to the stage where the stoma can be
reversed. In severe cases of anal Crohn’s disease, proctectomy may be
the only solution. This is often a diffi cult procedure and can result in a
new problem of an unhealed perianal wound.
(c) There is a school of thought that associates activity of intestinal disease
with activity of perianal disease, and there is some evidence to support
this belief. However, what is more controversial is the effect of resection
of intestinal disease on perianal disease activity. Logic would suggest that
resection of intestinal disease may improve the primary lesions of peria-
nal Crohn’s disease (fi ssures, edematous skin tags, and cavitating ulcer-
ation) but should have no effect on the secondary lesions such as anal
fi stulas. Therefore, in this case, ileal resection should only be considered
if the ileal disease is particularly troublesome. As her intestinal symptoms
appear to be controlled by budesonide, continuation of medical treatment
is probably the best option. A potential pitfall in the management of a
patient with active Crohn’s anal fi stulas is not appreciating that the fi stula
is extrasphincteric, and the fi stula arises from a loop of infl amed bowel
stuck in the pelvis.
63
4 Anorectal Fistula
Case Scenario Answers 3
(a) After a full history and general examination, careful perineal inspection is
performed, paying particular note of any features to suggest Crohn’s dis-
ease. The site of the external opening is recorded. This is an anterior fi s-
tula, with an external opening not too far from the anal margin. It is likely
to have a radial course from an internal opening in the midline anteriorly
(Goodsall’s rule). Careful palpation with a lubricated fi nger will reveal a
cord beneath the skin if the fi stula is superfi cial. Digital examination of
the anus may reveal a pit or induration at the site of the internal opening
and induration in the sphincters at the corresponding site. An endoanal
ultrasound can be helpful in confi rming the site of the internal opening
and the depth of the fi stula, but is not vital. A de novo fi stula like this does
not require an MRI unless there are features on digital examination to
suggest a complex fi stula. Further assessment is made under anesthetic.
Gentle probing will identify the fi stula track and the relationship to the
anal sphincters.
(b) The goals of treatment are similar for all fi stulas: resolve sepsis and pain
and hopefully heal the fi stula, at the same time preserving continence and
preventing cancer developing in an indolent fi stula. Patient expectation
has to be managed carefully, and informed consent is critical to the
patient’s perception of the outcome of surgery.
(c) The surgical approach depends on the complexity and depth of the fi stula.
This is an anterior fi stula in a woman who has had children. Most sur-
geons would be very cautious about laying open such a fi stula if this
involved division of anything other than the very lower fi bers of her exter-
nal sphincter, even though this is the procedure most likely to cure the
fi stula. However, the evidence for such a cautious approach is limited. A
school of thought claims that functional impairment is less after slow
division of sphincter muscle by tight seton. Again, the theory is fi ne, but
there is little evidence to confi rm this belief. A loose seton may be of
benefi t in the short term if the track is deep and particularly active, but
long-term seton drainage is not a good fi rst option, particularly in a young
woman who would fi nd the seton a problem during sexual intercourse. If
the surgeon is reluctant to divide sphincter muscle, an advancement fl ap
is a good option, either endorectal if the internal opening is in the upper
anal canal or cutaneous if the opening is in the lower anal canal. The
chance of a successful outcome is of the order of 75%. A fi stula plug
could be considered, but the fi stula track is likely to be short, and there are
some data to indicate that a fi stula plug is less likely to succeed in a short
fi stula. If the tissues are supple, exploration of the intersphincteric space
and ligation of the intersphincteric element of the track could be consid-
ered (LIFT procedure). Early results of this procedure are encouraging,
but there are no data on the long-term outcome of this procedure.
64
R. Nelson
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