The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anal Fissures

Abstract

The American Society of Colon and Rectal Surgeons (ASCRS) is dedicated to ensuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Clinical Practice Guidelines Committee is composed of society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus and develop clinical practice guidelines based on the best available evidence. Although not proscriptive, these guidelines provide information based on which decisions can be made and do not dictate a specific form of treatment. These guidelines are intended for use by all practitioners, health care workers, and patients who desire information on the management of the conditions addressed by the topics covered in these guidelines. These guidelines should not be deemed inclusive of all proper methods of care nor exclusive of methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician considering all the circumstances presented by the individual patient. STATEMENT OF THE PROBLEM The term anal fissure refers to a linear tear within the anal canal that usually extends from the dentate line toward the anal verge. Although this benign anorectal condition is commonly encountered in practice, there is a paucity of population-level data describing its incidence.1 Trauma and irritation to the anal canal, often precipitated by either constipation or diarrhea, can lead to development of an anal fissure. The primary symptom associated with anal fissures is anal pain, provoked by defecation, and may last for several hours after defecation. The pain is usually sharp, feels like a tearing sensation or “passing glass,” and can be debilitating because of the intensity. Anorectal bleeding may also be present, typically bright red when wiping. Anal fissures are most commonly located in the posterior midline (73%) but can be found in the anterior midline in 13% of women and 8% of men, with 2.6% occurring both anteriorly and posteriorly simultaneously.2 Lateral fissures or multiple fissures are considered to be an atypical presentation and require a more comprehensive evaluation because of the association with HIV infection, Crohn’s disease, syphilis, tuberculosis, and hematologic malignancies. Acute fissures, defined as symptoms present for <6 weeks,3,4 will appear as a longitudinal tear. Fissures of a longer duration will often manifest 1 or more stigmata of chronicity, including a hypertrophied anal papilla at the proximal aspect of the fissure, a sentinel tag at the distal aspect of the fissure, and/or exposed internal anal sphincter muscle within the base of the fissure. The pathogenesis of chronic fissures arises from underlying hypertonicity of the internal anal sphincter, leading to local ischemia and impaired wound healing.5 Most acute anal fissures are treated conservatively as recommended in the following section. The remainder of the practice guideline concerns patients with chronic anal fissure who present to a surgical clinic. MATERIALS AND METHODS These guidelines were built upon the previous ASCRS “Clinical Practice Guideline for the Management of Anal Fissures,” published in 2017.6 In comparison to the 2017 guideline, this guideline updated the evidence grade level on 4 recommendations, whereas the literature review and supporting text was updated for all other recommendations (Table 1). An organized search of MEDLINE, PubMed, Embase, Scopus, Web of Science, and the Cochrane Database of Collected Reviews was performed from October 1, 2014, through March 20, 2022, with the assistance of a medical librarian. Retrieved publications were limited to the English language and adult patients. TABLE 1. - What is new in the 2022 ASCRS anal fissure clinical practice guideline 2022 Updated recommendations 2. Anal fissures may be treated with topical nitrates, although headache symptoms may limit their efficacy. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. 3. Compared with topical nitrates, the use of calcium channel blockers for chronic anal fissures has a similar efficacy, with a superior side-effect profile, and can be used as first-line treatment. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. 4. Botulinum toxin has similar results compared with topical therapies as first-line therapy for chronic anal fissures and modest improvement in healing rates as second-line therapy following failed treatment with topical therapies. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. 8. Lateral internal sphincterotomy tailored to the length of the fissure yields similar healing rates but decreased fecal incontinence rates compared with traditional lateral internal sphincterotomy extending to the dentate line. Grade of recommendation: strong recommendation based on high-quality evidence, 1A. ASCRS = American Society of Colon and Rectal Surgeons. The search strategies were based on the concepts “anal fissure” and “fissure-in-ano” as primary search terms. Searches were also performed on the basis of various treatments for anal fissures, including “anal fissure AND nitroglycerin,” “anal fissure AND nitrates,” “anal fissure AND diltiazem,” “anal fissure AND nifedipine,” “anal fissure AND fiber,” “anal fissure AND botulinum,” “anal fissure AND sphincterotomy,” “anal fissure and fissurectomy,” “anal fissure and hemorrhoidectomy,” “anal fissure AND dilation,” and “anal fissure AND flap.” Directed searches of the embedded references from the primary articles were also performed in certain circumstances. The initial search generated 740 eligible studies, and after removing 201 duplicates, 539 studies were screened for initial inclusion, with an additional 84 studies identified through other sources. Abstracts were screened for relevance, leaving 324 studies that each underwent full-text review by 2 coauthors, with all conflicts resolved by a third coauthor. Following full-text review, 221 studies were excluded; 86 studies were included in the final article (Fig. 1).FIGURE 1.: PRISMA literature search flow chart. PRISMA = Preferred Reporting Item for Systematic Reviews and Meta-Analysis.Prospective, randomized controlled trials (RCTs) and meta-analyses were given preference, but in the absence of higher-level evidence, peer-reviewed observational studies and retrospective studies were included. The final grade of recommendation was performed using the Grades of Recommendation, Assessment, Development, and Evaluation system (Table 2).7 When the agreement was incomplete regarding the evidence base or treatment guideline, consensus from the committee chair, vice chair, and 2 assigned reviewers determined the outcome. Members of the ASCRS Clinical Practice Guidelines Committee worked in joint production of these guidelines from inception to final publication. The entire Clinical Practice Guidelines Committee reviewed recommendations formulated by the subcommittee. Final recommendations were approved by the ASCRS Executive Council and peer-reviewed in Diseases of the Colon and Rectum. In general, each ASCRS Clinical Practice Guideline is updated every 5 years. No funding was received for preparing this guideline‚ and the authors have declared no competing interests related to this material. This guideline conforms to the Appraisal of Guidelines for Research and Evaluation checklist. TABLE 2. - The GRADE system—grading recommendations Description Benefit vs risks and burdens Methodologic quality of supporting evidence Implications 1A Strong recommendation, high-quality evidence Benefits clearly outweigh risks and burdens or vice versa RCTs without important limitations or overwhelming evidence from observational studies Strong recommendation; can apply to most patients in most circumstances without reservation 1B Strong recommendation, moderate-quality evidence Benefits clearly outweigh risks and burdens or vice versa RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Strong recommendation; can apply to most patients in most circumstances without reservation 1C Strong recommendation, low or very low-quality evidence Benefits clearly outweigh risks and burdens or vice versa Observational studies or case series Strong recommendation but may change when higher-quality evidence becomes available 2A Weak recommendation, high-quality evidence Benefits closely balanced with risks and burdens RCTs without important limitations or overwhelming evidence from observational studies Weak recommendation; best action may differ depending on circumstances or patients’ or societal values 2B Weak recommendation, moderate-quality evidence Benefits closely balanced with risks and burdens RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Weak recommendation; best action may differ depending on circumstances or patients’ or societal values 2C Weak recommendation, low or very low-quality evidence Uncertainty in the estimates of benefits, risks, and burdens; benefits, risks, and burdens may be closely balanced Observational studies or case series Very weak recommendation; other alternatives may be equally reasonable GRADE = Grades of Recommendation, Assessment, Development, and Evaluation; RCT = randomized controlled trial.Adapted from Guyatt et al.7 Used with permission. RECOMMENDATIONS 1. Nonoperative treatment of acute anal fissures is safe and should typically be first-line treatment. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. Nearly half of all patients who have an acute anal fissure will resolve their symptoms with nonoperative measures such as sitz baths and the use of psyllium fiber or other bulking agents, with or without the addition of topical anesthetics or topical steroids.1,2,8–11 These interventions are well tolerated with minimal to no side effects. In a prospective randomized trial of 103 patients, treatment with sitz baths and fiber supplementation was associated with a greater likelihood of pain relief compared to topical anesthetics or topical hydrocortisone (91% vs 60% vs 68%, respectively; p < 0.05).8 In addition, in a double-blind placebo-controlled study of 75 patients with healed acute fissures, maintenance therapy with fiber was associated with lower rates of fissure recurrence compared with placebo (16% vs 60%; p < 0.01).10 There are no data supporting one type of fiber in comparison with another. Healing rates of anal fissures with conservative treatment appear to decrease as duration of symptoms increases. This was demonstrated in a prospective study of 60 patients, which observed a 100% healing rate in patients with symptoms of <1-month duration, compared to only a 33.3% healing rate in patients with symptoms of >6-month duration.12 The remainder of this clinical practice guideline discusses the management of chronic anal fissures. In general, chronic anal fissures require a tailored approach, as long-term consequences of surgical treatment, such as fecal incontinence (FI), may not manifest for several years. 2. Anal fissures may be treated with topical nitrates, although headache symptoms may limit their efficacy. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. Topical nitroglycerin is associated with healing in approximately 50% of chronic anal fissures.13 Based on a Cochrane meta-analysis of 18 randomized trials comparing topical nitrates to placebo, involving a total of 734 patients, the topical nitrate group was associated with a significantly decreased odds of fissure persistence or recurrence (OR 0.35; 95% CI, 0.19–0.65).14 A multicenter double-blind placebo-controlled trial of 200 patients with anal fissure demonstrated that escalating concentrations of topical glyceryl trinitrate (GTN) was associated with increased rates of severe headache, with no improvement in fissure healing rates. Specifically, rates of severe headache were 2%, 6.5%, and 24% in the 0.1%, 0.2%, and 0.4% GTN groups, respectively. Higher doses were not associated with increased rates of healing, evidenced by similar healing rates of 47%, 40%, and 54% in the respective escalating treatment groups (p = 0.3).15 Headache occurs in at least 30% of treated patients, is nearly ubiquitous in some reports,16,17 and leads to cessation of therapy in up to 20% of patients.18 Although level-1 evidence supports the efficacy of topical nitrates, the side-effect profile should be considered as well. Additionally, there was significant heterogeneity in the clinical trials regarding the dose and delivery of the medication. Based on this, we changed the recommendation grade to 1B because the benefits must be closely balanced with the side effects. 3. Compared with topical nitrates, the use of calcium channel blockers for chronic anal fissures has similar efficacy, with a superior side-effect profile, and can be used as first-line treatment. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. A small prospective clinical trial of 45 patients compared anal fissure healing rates between groups randomly assigned to topical glyceryl trinitrate or diltiazem (DTZ) and found no difference in healing rates (54.9% vs 66.7%; p = 0.2) or in the percentage of patients who ultimately failed topical therapy (45% vs 33%; p > 0.05).19 A 2013 systematic review of 7 randomized trials was conducted in 2013 with 238 patients treated with topical GTN versus topical DTZ. Although there was significant heterogeneity in the studies, DTZ was associated with a lower incidence of side effects (relative risk [RR] = 0.48 [0.27–0.86]) and lower incidence of headache (RR = 0.39 [0.24–0.66]) than GTN, with no difference in healing of chronic anal fissures (RR = 1.10 [0.90–1.34]).20 A more recent 2020 meta-analysis of 8 RCTs demonstrated DTZ was better tolerated than glyceryl trinitrate with regard to headache occurrence (RR = 0.15 [0.07–0.34]).21 Studies evaluating the use of oral calcium channel blockers to treat anal fissures have conflicting results. One RCT demonstrated improved efficacy with topical treatment over oral treatment (73.3% healing vs 49.5% healing; p < 0.05),22 whereas another report found equal success.23 Topical delivery is preferred, given the lower incidence of systemic effects associated with topical calcium channel blockers (4.3% vs 38.0%; p < 0.0001).22,24 Although there are several randomized clinical trials and meta-analyses evaluating this topic, the studies were heterogeneous and used different medications and different strengths; the available evidence supports a grade 1B recommendation. 4. Botulinum toxin has similar results compared with topical therapies as first-line therapy for chronic anal fissures and modest improvement in healing rates as second-line therapy following failed treatment with topical therapies. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. There is no consensus protocol for dosing of botulinum toxin or injection technique,25 and therefore, there is heterogeneity between studies with regard to the dose injected, site(s) injected, and number of injections. A Cochrane review from 2012 found no clear trend between dose, preparation, or injection site of botulinum toxin and associated healing rates.14 A meta-analysis of patients demonstrated no dose with regard to healing which from to or including an incidence of meta-analysis of patients from 18 clinical trials demonstrated greater efficacy with lower doses with the benefits of lower rates of both and with that there was a small decrease in healing rates by CI, and an in incontinence rate (RR = 95% CI, and recurrence rate (RR = 95% CI, 1 retrospective review addressed risk for that of with botulinum toxin included and lower studies that in comparison with to topical nitroglycerin and topical botulinum toxin is associated with healing in of patients, which is to the with topical A double-blind randomized trial comparing topical DTZ with of botulinum toxin placebo and topical demonstrated that both treatment were associated with a healing rate after and similar rates of patients at least a 50% in pain vs p = A meta-analysis from that botulinum toxin is as as nitroglycerin but that may be associated with a lower incidence of A multicenter randomized study performed in that botulinum toxin is more than topical with significantly improved rates of healing vs 33%; p = and with lower recurrence rates at 1 although this not vs p = The use of topical nitroglycerin with botulinum toxin has to healing and symptoms in patients with chronic anal A small prospective trial of patients compared treatment with of both nitroglycerin and botulinum to botulinum toxin and found improved healing rate in the group versus the botulinum toxin group vs p = retrospective studies evaluating botulinum toxin as second-line therapy after treatment with topical nitroglycerin have improved relief and of surgical the basis of multiple prospective randomized clinical trials and with the of significant heterogeneity between studies, the available evidence supports a grade 1B. Lateral internal sphincterotomy may be in patients with chronic anal fissure. Grade of recommendation: strong recommendation based on high-quality evidence, 1A. randomized trials have the of lateral internal sphincterotomy compared with topical nitrates, calcium channel or botulinum with healing rates of to 100% and with rates from 8% to 30% based on up to One for the superior results associated with may be the associated with long-term medical an that was by a recent Cochrane review comparing surgical and therapies for anal with duration of symptoms 1 are to to medical and rates of fissures with nonoperative and given that evidence of long-term fecal and quality of are in the of patients after can be as first-line therapy for chronic anal fissures in patients with no underlying in may be as first-line therapy women with patients with patients who have previous anorectal and patients with a anal sphincter is the treatment of for chronic anal fissures in patients without Grade of recommendation: strong recommendation based on high-quality evidence, 1A. the most surgical procedure for chronic anal fissure in patients without incontinence to or that is superior to anal superior healing rates with lower A Cochrane review of patients in 7 studies found that anal compared to was associated with a increased rate of fissure (OR 95% CI, and greater incidence of incontinence (OR 95% CI, has in one small although this treatment has not to as a has compared to in one randomized trial of patients, no incontinence or recurrence in the compared to a rate of incontinence and recurrence rate with In 2 botulinum toxin with to healing in 95% of treatments may be to to patients with and to previous treatment, an may be considered as an surgical treatment, with 2 RCTs 200 patients low rates of between and and other studies healing rates of to and of similar results and either may be Grade of recommendation: strong recommendation based on high-quality evidence, 1A. studies have demonstrated that there are no significant in between performed and surgical with healing rates of to 100% and to and rates of to and to A Cochrane of 5 studies including patients also this no difference with regard to fissure healing (OR 95% CI, and incontinence to (OR 95% CI, regard to pain and a randomized study of patients demonstrated that sphincterotomy was associated with significantly pain and a healing rate of the surgical site at in the compared to no healing in the group (p = 8. tailored to the length of the fissure yields similar healing rates but decreased rates compared with traditional extending to the dentate line. Grade of recommendation: strong recommendation based on high-quality evidence, 1B. defined as sphincterotomy limited in to the of the fissure, was to the rate of after the defined as internal sphincter muscle as as the dentate line. randomized trials patients comparing versus tailored sphincterotomy fissure healing rates in both from 95% to regard to one of the studies found an increased rate of incontinence in the traditional versus tailored vs p = and the other a significant in incontinence compared to in the group vs p = but not in the tailored group vs p = In the third there were incontinence in the tailored but this not vs p = of the these studies demonstrated a low incidence of and of These studies used the to A prospective study of women the of tailored for chronic anal fissure, of previous and patients were on the basis of the of the total sphincter length or found that incontinence were significantly lower for the compared to the vs p = supporting the tailored a retrospective study of patients who underwent tailored a found only a rate of with no patients incontinence to of or botulinum injection for anal fissure have healing rates with a low risk of but the data are limited and require Grade of recommendation: weak recommendation based on low-quality evidence, one study has the of for chronic anal fissures. patients underwent tailored and a healing rate and a rate at a An used in a study of patients with anal fissure after was to botulinum toxin the internal anal sphincter, which in a healing rate of with a rate of studies with longer are on this is a safe surgical for chronic anal fissure with a decreased risk of compared with and healing rates. Grade of recommendation: weak recommendation based on moderate-quality evidence, patients with chronic anal fissure who are at risk for after an surgical is an or which has using a of and which has associated with fissure healing rates and low rates of A prospective study a healing rate at 2 after the of a in patients, with no or in at a of A retrospective study compared the of patients = and = at a of fissure healing was in of patients who underwent anal and of (p = with no in either A prospective study comparing = to = a rate of in and in (p = A similar prospective study found that = a rate of and in (p = of the 2 studies healing rates. prospective trials are to better the of in the treatment of anal fissures. The addition of an to botulinum toxin injection or to may decrease pain and for primary wound Grade of recommendation: weak recommendation based on low-quality evidence, studies have demonstrated for patients with either botulinum toxin injection or In 2 prospective studies patients, a with botulinum toxin injection was associated with healing rates of to 100% at from up to with in pain from to and with rates of A study of 45 patients treated with a of and botulinum toxin injection demonstrated of pain by recurrence rate at 5 and rate of In a retrospective study comparing the results of patients who underwent tailored to patients who underwent the tailored group significantly pain (p < healing vs healed at 2 p < with all healed at and low rates of incontinence vs p < a randomized study of patients who underwent = = or with = and who were for 1 found healing rates were and (p = recurrence rates were and (p = and rates were and (p = that the addition of the may healing rates and rates of Although there is one randomized the of studies were or and given the for risk and the evidence supports a grade 2C recommendation.