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40 Chronic andRefractory Anal Fissure: What Are theTreatment Options?
https://t.me/medicina_free
LIS is superior to non-operative management in
achieving a sustained cure. The incontinence risk with
LIS is 3.4– 4.4%. Open and closed LIS are equally
efcacious with a moderate quality of evidence. CCBs
are more effective than GTN with lower rates of HA,
but with low quality of evidence, especially due to short
Conclusions
and lowest no-success rate) but has an incontinence risk
over 9%. A stepwise approach is recommended. Firstly,
medical treatment is safe with few side effects. In
persistent CAF, ssurectomy and/or BT may be used
to address both ssure scarring and sphincter
hypertonicity. In patients with treatment failure, LIS
may be used but patients should be selected carefully to
minimize risk of postoperative incontinence. Anoplasty
and/or ssurectomy and BT may be good
alternatives. Anal dilatation had the highest
incontinence risk exceeding 18% and should be
abandoned in clinical practice.
follow-up times in prior studies.
AAF is associated with similar rates of wound
complications and unhealed ssure as LIS, but with
lower incontinence rates.
461
(continued)
44 RCTs 3268 NR LIS is the most effective treatment (highest healing rate
Studies, n &
Study Type Pt, n Intervention: n
Databases used;
time period
(PubMed);
1/1975–
10/7/2015
Yr
Ebinger 2017 Medline
First Author
Non-surgical: 9456.
12,062 Surgical: 2606.
Surgical: 31
RCTs.
Non-
surgical: 117
RCTs.
2017.
Medline;
1950– 1/18/2017.
EMBASE;
1/17/2017.
Nelson 2017 Cochrane; Issue 3,
LIS: 150
300 AAF: 150
2 RCTs, 2
retrospective
ClinicalTrials.gov
and ICTRP; up to
CINAHL,
3/7/2017.
Sahebally 2018 PubMed/Medline,
studies
EMBASE,
Cochrane;
Inception to
1/2017
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Conclusions
DTZ should be considered as the rst line non-
operative treatment for CAF.DTZ and GTN have
comparable healing rates, but DTZ is superior in regards
LIS has the highest healing rate at 8 weeks but with a
small risk of causing permanent incontinence. Topical
nitrates and BT also have reasonable results. Ultimately,
management of CAF should be tailored to the patient.
As a generalization, topical therapies should be tried
rst, followed by ssurectomy with/without BT and/
or AAF, before LIS.
to HA and late recurrence rates.
are an effective treatment for anal ssure in terms of
healing and pain reduction compared to placebo, but it
has a signicant risk of HA. DTZ is marginally better
than GTN for healing; however, the certainty of
evidence is very low. CCBs are less likely to cause HA
G.-r. Han and N. Mishra
compared to topical nitrates. Further studies are required
to establish the effectiveness of CCBs compared to
placebo.
9 RCTs 756 DTZ: 385
Studies, n &
Study Type Pt, n Intervention: n
Databases used;
time period
Yr
(continued)
Nevins 2020 Medline, Embase,
First Author
Table 40.3
DTZ: 44
GTN: 371
PubMed, Scopus,
Google Scholar;
Since 1/2000
Minoxidil 44
9 RCTs 775 Nitrates: 206
Cochrane, Scopus;
1/2000– 2/8/2020
Boland 2020 PubMed,
BT: 132
LIS: 349
37 RCTs 2888 NR There is low certainty evidence that topical nitrates
EMBASE,
Scopus, Cochrane;
NR
Jin 2022 Medline,
40 Chronic andRefractory Anal Fissure: What Are theTreatment Options?
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Conclusions
LIS had the highest healing rates and should be
considered as the denitive treatment after failed
initial therapy with BT or medical therapies. BT was
equally effective compared to medical treatment.
AAF shows similar effectiveness compared to LIS, but
more studies are needed to evaluate its efcacy.
463
BT + Med: 84.
BT: 714.
Studies, n &
Study Type Pt, n Intervention: n
69 RCTs 6242 Med: 1935.
Databases used;
time period
EMBASE,
Cochrane;
Yr
First Author
Jin 2022 Medline,
Self-massage: 25.
Anal dilation: 158.
Anal dilation + Med: 16.
Sphincterolysis: 41.
AAF: 70.
1/1/1990–
2/15/2021
AAF + LIS: 50.
Fissurectomy: 30.
pLIS: 93.
LIS: 2989.
toxin injection, LIS Lateral internal sphincterotomy, AAF Anal advancement ap, CAF Chronic anal ssure, DARE Database of Abstracts of Reviews of Effects,
HTA Health Technology Assessment, CCCG The Cochrane Colorectal Cancer Group Controlled Trials Register, Cochrane The Cochrane Central Register of
Controlled Trials, ICTRP World Health Organization’s Internet clinical trial portal, Med Medical therapy, pLIS Partial lateral internal sphincterotomy
Abbreviations: Yr Year, NR Not reported, Pt Patients, RCT Randomized controlled trial, DTZ Diltiazem, GTN Glyceryl trinitrate, HA Headache, BT Botulinum
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G.-r. Han and N. Mishra
ssure, including ber supplementation with appropriate water intake and stool
softeners to ensure regular bowel movements and sitz baths for symptomatic relief.
Initial management of CAF is usually with medical therapy as this approach is
safe with few side effects, especially given the concern for anal incontinence with
sphincterotomy. A systematic review and meta-analysis including 37 studies with
2888 patients to evaluate the efcacy of topical treatments for anal ssures found
that topical diltiazem and topical nifedipine are both better at achieving ssure healing than topical glyceryl trinitrate (GTN). In addition, there was a signicantly
higher risk of headaches with GTN compared to placebo or topical CCB.There
have been more studies comparing GTN to placebo than for CCB to placebo; these
studies have demonstrated that GTN is more effective at healing anal ssures and
reducing pain compared to placebo, but this was not found in the three studies that
compared topical CCB to placebo. Of note, this systematic review and meta- analysis
did include patients with both acute and chronic anal ssures, and the studies were
noted to have high heterogeneity and signicant publication bias [3]. A 2017 systematic review including 117 RCTs studying non-surgical therapies with 9456
patients had similar results. This study demonstrated that topical CCB are more
effective than GTN with decreased risk of headaches, but with a low grade of evidence, mainly due to limited follow-up times in the included studies [4].
An RCT by Khan etal. studying 184 patients with CAF randomized half the
patients to treatment with 0.2% topical GTN and the other half to 2% topical diltiazem. After 1month of treatment, 80% of patients treated with diltiazem achieved
ssure healing which was signicantly greater than the 62% who achieved healing
with GTN.There was a higher incidence of patients who had resolution of perianal
pain with diltiazem at 73% compared to GTN at 63%, but this did not reach statistical signicance [5].
These results are similar to the RCT by Shrestha etal. studying 90 patients randomized evenly to treatment with 2% GTN and 0.5% nifedipine [6]. This study
found an 83% healing rate with nifedipine use at 8weeks which was signicantly
higher than the 60% of patients who had ssure healing using GTN.There was also
a signicantly lower rate of ssure recurrence in 6months with nifedipine compared to GTN (24% and 18%, respectively). 17% of patients with GTN complained
of headache compared to 7% in the nifedipine group, which led to poor compliance
among the GTN users [6].
Alternative topical treatment that have not yet been extensively studied include
minoxidil. A 2020 study by Emile etal. looking at 30 patients treated with 5% minoxidil and 32 patients treated with 0.2% GTN showed a signicantly higher rate of
healing with minoxidil at 77% compared to 47% with GTN, as well as a shorter
duration to healing and fewer adverse effects. However, the patients treated with
GTN had a signicantly lower perianal pain score compared to those using minoxidil [7].
Another topical therapy that has not been proposed, but not widely studied for
the management of CAF is topical tocopherol acetate. Ruiz-Tovar etal. studied 160
patients evenly divided into two groups treated with 100% tocopherol acetate and
0.4% GTN. Compared to the group treated with GTN, those managed with
40 Chronic andRefractory Anal Fissure: What Are theTreatment Options?
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465
tocopherol acetate had a signicantly higher cure rate (87% vs 66%), higher resolution of pain (88% vs. 70%), and lower recurrence rate at 16weeks after completing
the treatment course (3% vs. 13%). In the GTN arm, there were 28% of patients
who had mild to moderate headaches and 18% with severe, incapacitating headaches while none of the patients in the tocopherol acetate group reported this sideeffect [8]. Due to the limited number of studies evaluating the safety and efcacy of
topical tocopherol acetate, it is not yet an accepted treatment for CAF, but it remains
a promising area for future research.
Although GTN has been more extensively studied than CCB, it appears that topical CCB are superior at treating CAF with fewer intolerable side-effects and lower
recurrence rates. However, medical treatment of CAF is limited by a signicant risk
of symptom recurrence compared to other therapies such as BT or surgical procedures [9].
BT injection represents a step between management with topical agents and surgical treatment, but the dosage and the injection protocol has not yet been wellestablished, and it is debatable if it offers any signicant benet over medical
therapy. The dosages of BT injected according to various studies range from 20IU
to 150IU [10, 11]. The protocol for internal sphincter BT injection is quite variable
with some surgeons inltrating BT at the 3 and 9 o’clock positions, other surgeons
doing so on each side of the anterior midline or posterior midline, and still others
injecting it at the four perianal quadrants [10, 12, 13]. Some surgeons inject BT in
the intersphincteric groove whereas others inject it in the internal sphincter muscles.
Therefore, the technique and dosage for BT injection is quite heterogeneous which
makes it difcult to interpret prior studies.
A meta-analysis including six RCTs with 393 patients comparing BT to topical
nitrates for the treatment of CAF showed lower incidences for incomplete ssure
healing and ssure recurrence with BT compared to topical nitrates, but these rates
did not reach statistical signicance [14]. There was a higher rate of total side effects
with topical nitrates but patients who underwent BT injection had an increased risk
of transient anal incontinence [14]. A 2022 systematic review with network metaanalysis by Jin et al. including 69 RCTs also failed to demonstrate a signicant
difference in ssure healing between BT and topical medications [9].
A 2020 RCT by Nour etal. compared 48 patients undergoing BT injection to 48
patients undergoing partial or tailored lateral internal sphincterotomy (pLIS) [13].
The BT group had 80IU inltrated in the internal anal sphincter at the 1:00, 5:00,
7:00 and 11:00 positions. In the BT group, postoperative pain was lower, but the
pLIS group had a higher rate of healing (92% vs. 77%) and a lower rate of recurrence (2% vs. 14%). The BT group had a higher rate of early postoperative incontinence at 17%, but symptoms had all resolved by 6months post-treatment. In the
pLIS group, there were 10% who developed incontinence, but 4% unfortunately had
persistent gas incontinence after 6months. The authors concluded that BT is safer
than pLIS but is less effective and its dose needs to be adjusted. pLIS is more effective but preoperative assessment of anal sphincter tone is essential [13]. Unlike this
study, a systematic review and meta-analysis published in 2017 found lower rates of
anal incontinence with both LIS and BT at up to 4.4% and 2.3%, respectively [4].
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It is possible that the duration of CAF symptoms may also play a factor in the
effectiveness of different treatment modalities. A study by Gandomkar etal. randomized 99 patients with CAF to undergoing pLIS or receiving combination therapy with BT injection and topical diltiazem ointment for 6weeks [11]. The overall
healing rate in the 1-year follow-up period was signicantly higher for the pLIS
group at 94% vs. 65% in the BT with diltiazem group. The overall recurrence rate
was 10% in the combination therapy group while none who had pLIS had recurrence. Incontinence was higher in the pLIS group. By the end of the study period,
all the patients with incontinence in the combination therapy group had resolution
of their symptoms, but 2% in the pLIS group had persistent incontinence. The
authors performed an interesting subanalysis based on duration of CAF symptoms.
Patients with symptoms for ≤12months were found to have a 100% healing rate in
both treatment arms, and none of these patients suffered a recurrent ssure. Patients
with CAF for >12 months had signicantly greater success with undergoing
pLIS.Therefore, the authors suggested that BT with diltiazem may be just as effective as pLIS in patients with CAF symptoms for ≤12months. Patients with CAF for
a longer duration should consider pLIS instead due to its higher rate of healing.
Surgical options for CAF include LIS, AAF, anal dilatation, and ssurectomy.
LIS remains the gold standard for CAF treatment with the highest rates of cure
(88%– 100%) and the lowest rates of recurrence [15, 16]. A meta-analysis by Acar
etal. including 550 patients who underwent treatment with LIS, pLIS, 2% diltiazem
and 0.2% GTN showed the highest rates of healing with sphincterotomy (93%,
86%, 69% and 63%, respectively) [17]. The results for achieving resolution of perianal pain were similar. The recurrence rates were only available for those who
underwent sphincterotomy and was 4% for LIS and 12% for pLIS.Both sphincterotomy groups had a 2% rate of incontinence but all the patients in the pLIS group
had resolution of the incontinence by 6months. The authors concluded that medical
therapy may be tried as the rst step and that pLIS could be considered as an effective alternative therapy due to the decreased risk of incontinence compared to a
standard LIS [17].
These results are similar to the ndings of a 2017 systematic review by Nelson
etal. which actually studied all the treatment modalities for CAF and included 31
publications on surgical techniques and 117 on non-operative methods. They found
that LIS is the most effective method of achieving sustained cure of CAF.Anal
incontinence which is a feared side-effect with sphincterotomy was found to occur
in up to 4.4% of patients. In addition, they found equivalent results with the open
and closed techniques of performing an LIS. Manual anal dilation was found to
have a lower rate of healing and higher rate of incontinence as 12% compared to LIS
[4]. A 2021 RCT by Bara etal. comparing patients undergoing LIS with those
undergoing anal dilatation and ssurectomy also noted signicantly higher rates of
incontinence with the anal dilatation and ssurectomy [18]. When aiming to guarantee the highest chances of perianal pain relief with the lowest risk of recurrence,
LIS remains the gold standard [4].
40 Chronic andRefractory Anal Fissure: What Are theTreatment Options?
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467
pLIS can be combined with AAF for the treatment of CAF as shown in a 2012
RCT by Magdy etal. which studied 150 patients with CAF randomized to treatment
with LIS, V-Y advancement ap, or combined pLIS with V-Y advancement ap.
The highest healing rate was achieved with the combined technique at 94% with the
lowest rate of recurrence at 2% and a low rate of postoperative incontinence at
2% [15].
The current literature is limited in guiding management of atypical or recurrent
anal ssures, as almost all the studies exclude patients with these characteristics.
Recurrences after sphincterotomy may be due to incomplete division of the sphincter muscle, so a repeat examination under anesthesia with completion of the sphincterotomy to the dentate line or repeat pLIS could be trialed in patients with normal
or high anal sphincter tone [19]. An interesting retrospective study including 57
patients with recurrent anal ssures underwent repeat pLIS at the opposite side to
the original sphincterotomy. The authors found that 98% of these patients achieved
cure of their ssure with high patient satisfaction scores, and only 4% had postoperative incontinence [20].
Patients who are inappropriate surgical candidates and have failed other therapies could be considered for transcutaneous electrical nerve stimulation (TENS)
based on a 2015 RCT by Youssef etal. including 73 patients randomized to LIS and
TENS [21]. In this study, 75% of patients in the TENS arm had improvement of
their symptoms within one month of treatment compared to 100% in the LIS arm.
However, the recurrence rate with TENS was signicantly higher at 41% compared
to 3% in the LIS group [21].
Another option for patients who develop recurrent anal ssures after prior
sphincterotomy, or for those with poor baseline anal sphincter tone or risk factors
for postoperative incontinence, would be performing an AAF.Sahebally et al’s
2018 meta-analysis including 2 RCTs and 2 retrospective studies showed similar
rates of ssure healing and wound complications between LIS and AAF.In addition, AAF was associated with lower rates of incontinence. The included studies
lacked enough data to analyze recurrence rates; therefore, the authors were unable
to comment on the sustainability of ssure healing [22]. However, a prior RCT
comparing LIS with AAF noted a signicantly higher rate of recurrence at 22%
with AAF compared to 4% with LIS [15]. Since AAF does not address the contribution of anal sphincter hypertonia to the development of ssures and with previous studies suggesting that there is a higher recurrence rate than with
sphincterotomy, this technique may be more suitable for those without baseline
increased anal sphincter tone or those who are at increased risk of developing
postoperative issues with continence.
Further studies are needed to determine the dosing and injection protocol for BT,
the order in which treatments should be performed for those with CAF, and the best
treatment modalities for those with atypical, refractory, or recurrent ssures.
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Recommendations
1. Medical therapy is usually considered as the rst line step. Topical CCBs may be
a better medical treatment option than topical nitric oxide donors, especially
because of the decreased patient compliance due to a signicant incidence of
headaches with the latter.
– Moderate level of evidence; Weak recommendation
2. Surgical intervention with sphincterotomy offers the best healing rate and may
be used when anal ssures do not respond to nonoperative therapy. Anal sphincter tone and risk factors for developing incontinence should be carefully assessed
prior to consideration of sphincterotomy.
– High level of evidence; Strong recommendation.
Personal View
Chronic anal ssures can be quite debilitating for patients as they cause pain and
bleeding. Moreover, many patients worry about cancer when they see bleeding
associated with bowel movements. It is important for the treating physician to reassure the patient that the likelihood of a typical anal ssure harboring cancer is very
low. It is also important to make sure that the patients are up to date with their
screening colonoscopies depending on their age and colon cancer risk stratication
when we evaluate the patient for an anal ssure.
Treatment of atypical CAFs is directed towards the etiology; we start with a
biopsy of the ssure and the results guide the treatment. Treatment of typical ssures is directed towards reduction of the tone of the internal anal sphincter. For
typical CAFs, our practice is geared towards symptomatic relief of anal ssures and
not towards healing, per se. We set this expectation up-front when we meet with the
patient, and most often the patient shares this goal. Ideally, we want both bleeding
and pain to resolve; however, if we can relieve the pain and the patient notices on
and off anal outlet bleeding, we consider that as a success and as an acceptable
endpoint in treatment of CAFs. We offer LIS as the initial treatment for patients
(especially men) who are in severe pain and have failed conservative treatment at an
outside facility. For all other typical CAFs we start treatment with sitz baths, ber
supplementation, adequate water intake and topical CCBs (2% Nifedipine 3 times a
day) for 2months. If this does not cause substantial improvement or complete resolution of symptoms, then we offer the patients BT injection. If the patient has had
partial improvement and is not in distress, then continuing CCBs for another
2months is an excellent option. For those patients who need BT injection, we inject
a total of 100units of BT: 30units are injected on either sides of the ssure into the
internal anal sphincter muscle and 40units are injected into the internal anal sphincter muscle opposite the anal ssure (i.e. if it is a posterior midline anal ssure, then
we inject 30units into the internal anal sphincter muscle on either side of it and
40 units are injected in the anterior midline). After injecting BT, we advise the
patient to continue using the topical CCBs and reassess them in 2months. If the
40 Chronic andRefractory Anal Fissure: What Are theTreatment Options?
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469
patient has had partial improvement from the BT injection and is not in distress,
then repeating BT injection is a reasonable option. If the symptoms have not substantially improved or there has not been complete resolution of symptoms, then we
discuss LIS; in our practice, we quote a 98% success rate with a 2% rate of incontinence to atus in the long term. In our practice, we perform LIS using a closed
technique and tailor the length of the sphincterotomy to the length of the ssure.
Any patient with a ssure-stula is best served with a ssure stulotomy with marsupialization of the stula tract, as most often that is curative.
Rarely, some patients have atypical CAFs without increase in anal tone. Our
initial approach of to treat these patients remains the same. We start with Sitz baths,
ber supplementation, adequate water intake and topical CCB (2% Nifedipine 3
times a day) for 2months. However, if they fail to improve and are in pain, then we
offer them an AAF as the surgical option.
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medical treatment of chronic anal ssures-a review and network meta-analysis of randomized
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2. Arslan K, Erenoğlu B, Doğru O, Turan E, Eryilmaz MA, Atay A, etal. Lateral internal sphincterotomy versus 0.25% isosorbide dinitrate ointment for chronic anal ssures: a prospective
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