close

Log in

Access to premium content is restricted to healthcare professionals / registered members. Login with your email address to continue.

Forgot Your Password?

Don't have an account? Sign up

By signing in or creating an account, you agree to our Terms and conditions and Privacy notice

This site is intended for Healthcare Professionals only
Back to CKS

Gastrointestinal

Anal fissure

Last revised in April 2021

An anal fissure is a tear or ulcer in the lining of the anal canal, immediately within the anal margin.

Anal fissure: Summary

  • An anal fissure is a tear or ulcer in the lining of the anal canal which causes pain on defecation. It is classified as:
    • Acute — if present for less than 6 weeks.
    • Chronic — if present for 6 weeks or longer.
    • Primary — if there is no clear underlying cause.
    • Secondary — if there is a clear underlying cause, such as constipation, inflammatory bowel disease, sexually transmitted infection, or colorectal cancer.
  • Anal fissures are common. Peak incidence occurs in people aged 15–40 years but anal fissures can occur at any age. Primary anal fissures are uncommon in elderly people and warrant further investigation for an underlying cause.
  • Clinical features of anal fissure include anal pain with defecation (with or without bright red rectal bleeding) and anal spasm.
  • External examination of the anus may reveal a linear split in the anal mucosa.
    • Acute anal fissures are usually superficial with well-demarcated edges.
    • Chronic anal fissures are wider and deeper with muscle fibres visible in the base. The edges are often swollen, and a skin tag may be visible at the end of the fissure.
    • Primary anal fissures usually occur in the posterior midline, although about 10% of cases occur anteriorly (especially in women).
    • Secondary anal fissures should be suspected if fissures have an irregular outline, are multiple, or occur laterally.
    • Referral for examination under anaesthesia may be needed if the diagnosis is unclear or if anal spasm and pain make diagnosis difficult.
  • Management of anal fissure includes:
    • Referral to secondary care if a serious underlying cause (such as rectal cancer or inflammatory bowel disease) is suspected.
    • Giving dietary and lifestyle advice to ensure stools are soft and easy to pass (such as a high fibre diet and increased fluid intake) and to aid healing of the fissure (such as good anal hygiene).
    • Offering simple analgesia (paracetamol or ibuprofen) and advising on measures to reduce pain (such as soaking in a shallow, warm bath) — a short course of topical anaesthetic can also be considered for adults with extreme pain on defecation.
    • For adults whose symptoms have persisted for 1 week or more without improvement considering a 6–8 week course of rectal glyceryl trinitrate (GTN) ointment.
    • For people with secondary anal fissure, managing the underlying cause, where possible, or referring the person to secondary care (using clinical judgement to determine the urgency) if a serious underlying cause (such as rectal cancer) is suspected.
  • For adults with primary anal fissure, review should be arranged at 6–8 weeks (or sooner if necessary).
    • People whose anal fissure has healed should be advised to continue with the dietary and lifestyle measures to reduce the risk of recurrence.
    • People with unhealed anal fissure despite adherence to dietary and lifestyle measures should be referred to a general or colorectal surgeon.
  • For children, specialist advice should be sought if an anal fissure has not healed after 2 weeks (or sooner if there is significant pain).

Have I got the right topic?

From age 1 month onwards.

This CKS topic covers the primary care management of people with anal fissure.

This CKS topic does not cover the diagnosis and management of secondary causes of anal fissure (such as constipation, sexually transmitted infection, inflammatory bowel disease, and colorectal cancer).

There are separate CKS topics on Constipation, Constipation in children, and Haemorrhoids.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.

How up-to-date is this topic?

Changes

April 2021 — reviewed. A literature search was conducted in March 2021 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. No major changes to recommendations have been made.

Previous changes

January 2017 — minor update. Update to reflect name change of ERIC, The Children's Bowel & Bladder Charity.

July 2016 — reviewed. A literature search was conducted in March 2016 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. No major changes to recommendations have been made, but the topic has been restructured.

November 2012 — reviewed. A literature search was conducted in September 2012 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of this topic. Minor changes to the structure have been made and a referral section added. Minor changes to the recommendations have been made based on evidence from a Cochrane Systematic review Non-surgical therapy for anal fissure.

July 2011 — minor update. More exact paracetamol dosing for children has been introduced by the Medicines and Healthcare products Regulatory Agency. Prescriptions have been updated to reflect the revised dosing. Issued in July 2011.

January 2011 — topic structure revised to ensure consistency across CKS topics — no changes to clinical recommendations have been made.

August 2009 — minor update. Advice from the National Institute for Health and Care Excellence guideline on when to suspect child maltreatment has been added to this topic. Issued in August 2009.

January to May 2008 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. There are no major changes to the recommendations.

October 2005 — minor update to include a prescription for glyceryl trinitrate 0.4% ointment (now licensed). Issued in November 2005.

July 2005 — updated to incorporate the Referral guidelines for suspected cancer published by the National Institute for Health and Clinical Excellence. Issued in July 2005.

December 2004 — reviewed. Validated in March 2005 and issued in April 2005.

September 2001 — reviewed. Validated in November 2001 and issued in April 2002.

October 1998 — written replacing previous guidance on Anal fissure.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 April 2021.

HTAs (Health Technology Assessments)

No new HTAs since 1 April 2021.

Economic appraisals

No new economic appraisals relevant to England since 1 April 2021.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 April 2021.

Primary evidence

No new randomized controlled trials in the major journals since 1 April 2021.

New policies

No new national policies or guidelines since 1 April 2021.

New safety alerts

No new safety alerts since 1 April 2021.

Changes in product availability

No changes in product availability since 1 April 2021.

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Make a diagnosis of anal fissure.
  • Manage a person with anal fissure in primary care by offering pain relief and advising on measures to promote healing, prevent recurrence, and relieve pain.
  • Refer a person with anal fissure to secondary care, where appropriate.
  • Manage a person with unhealed or recurrent anal fissure.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

No audit criteria were found during the review of this topic.

QOF indicators

No QOF indicators were found during the review of this topic.

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE quality standards

No NICE quality standards were found during the review of this topic.

Background information

What is it?

  • An anal fissure is a tear or ulcer in the lining of the anal canal which causes pain on defecation.
    • Anal fissures most often occur in the posterior midline of the anal canal.
  • Anal fissures can be classified as:
    • Acute — if present for less than 6 weeks.
    • Chronic — if present for 6 weeks or longer.
    • Primary — if there is no clear underlying cause.
    • Secondary — if there is a clear underlying cause.

[Schlichtemeier and Engel, 2016; Sahebally, 2017; Arroyo, 2018; BMJ Best Practice, 2019; Newman, 2019; Boland, 2020]

What causes it?

  • Primary anal fissures do not have a clear underlying cause.
    • Acute anal fissure can occur due to trauma from passing hard or loose stools, but many cases are not associated with constipation or diarrhoea.
    • Other aetiological theories suggest that development of anal fissure may be associated with:
      • A persistent increase in internal anal sphincter tone which leads to reduction in arterial blood flow, local ischaemia, increased risk of tearing, and poor healing of the resulting fissure.
      • Local deficiency in nitric oxide synthase which is needed for production of nitric oxide (the main mediator of internal anal sphincter relaxation).
  • Secondary anal fissures can present with atypical features and are associated with an underlying condition. For example:
    • Constipation — passage of hard stool tears the anal mucosa.
    • Conditions which can cause ulceration of the anal mucosa such as:
      • Inflammatory bowel disease.
      • Sexually transmitted infections such as HIV, syphilis, and herpes simplex.
      • Colorectal cancer.
      • Dermatological conditions such as psoriasis and pruritus ani.
      • Bacterial, fungal, or viral skin infections.
    • Anal trauma, for example from previous anal surgery or anal sex.
    • Adverse drug effects, for example opioid analgesics, nicorandil, and chemotherapy.
    • Pregnancy and childbirth (due to pressure on the perineum). Fissures related to childbirth are most commonly located in the anterior midline.

[Bhardwaj, 2007; Altomare et al, 2011; Madalinski, 2011; BPAC New Zealand, 2013; Foxx-Orenstein et al, 2014; Henderson and Cash, 2014; UKMi, 2015; Bobkiewicz, 2016; Schlichtemeier and Engel, 2016; Stewart, 2017; BMJ Best Practice, 2019; Newman, 2019; Boland, 2020; Gardner, 2020; Jahnny, 2021]

How common is it?

  • Although anal fissures are common, epidemiological data are lacking.
    • Annual incidence is thought to be around 1.1 per 1000 person-years.
    • Peak incidence occurs in people aged 15–40 years but anal fissures can occur at any age, including in young children (often due to poor toileting).
    • One population-based retrospective analysis (n = 1243) of people treated for anal fissure [Mapel, 2014] found that annual incidence of anal fissure varied from 0.05% in children aged 6–17 years to 0.18% in people aged 25–35 years.
  • Males and females are equally affected.
    • Anal fissures can occur in pregnant and postpartum women and are the second most common gastrointestinal complication of pregnancy (after haemorrhoids).
  • Primary anal fissures are uncommon in elderly people.
  • Acute anal fissures are more common than chronic anal fissures.

[Lund, 2006; Altomare et al, 2011; Bobkiewicz, 2016; Sahebally, 2017; Stewart, 2017; BMJ Best Practice, 2019; Newman, 2019; Boland, 2020; Patkova, 2020]

What is the prognosis?

  • Primary anal fissures
    • Around half of all acute primary anal fissures resolve within 6–8 weeks of conservative treatment (dietary/lifestyle measures and pain relief).
    • Spontaneous resolution may occur within 2 weeks (often before medical attention is sought).
    • Approximately 40% of people who present with an acute anal fissure progress to chronic anal fissure.
    • Chronic primary anal fissures are more resistant to conservative measures and often more intensive secondary care treatments are needed.
    • Recurrence of anal fissure is common, especially if dietary and lifestyle measures are not adhered to.
  • Secondary anal fissures
    • Prognosis of a secondary anal fissure is dependent on the prognosis of the underlying cause.

[Lund, 2006; Altomare et al, 2011; Zaghiyan, 2011; Nelson, 2012; BPAC New Zealand, 2013; Henderson and Cash, 2014; Bobkiewicz, 2016; Schlichtemeier and Engel, 2016; Sahebally, 2017; Stewart, 2017; BMJ Best Practice, 2019; Boland, 2020]

What are the complications?

  • Complications of anal fissure include:
    • Failure to heal/progression to chronic fissure.
    • Recurrent fissure.
    • Anorectal fistula.
    • Infection and/or abscess.
    • Faecal impaction — avoidance of defecation to prevent anal pain may worsen constipation and lead to faecal impaction.
    • Reduced quality of life due to pain (especially in people with chronic or recurrent anal fissure).

[BMJ Best Practice, 2019; Newman, 2019; Jahnny, 2021]

Diagnosis of anal fissure

How should I diagnose an anal fissure?

  • Take a history.
    • Ask about symptoms.
      • Anal pain always occurs with passing a stool — pain is severe and sharp and often followed by deep burning pain that persists for several hours.
      • Bleeding may occur with defecation. When present, it is usually seen as a small quantity of bright red blood on the stool or toilet paper.
      • A tearing sensation on passing stool may also be described.
      • In children, anal fissure typically presents with pain and/or crying during defecation and rectal bleeding.
    • Ask about the duration of symptoms.
      • Acute anal fissures are present for less than 6 weeks.
      • Chronic anal fissures are present for 6 weeks or longer.
    • Ask about features of an underlying cause including:
      • Dietary and bowel habits (for example constipation, diarrhoea, or any recent changes). Children often have constipation — pain on defecation may lead to stool retention and harder bulkier stools which cause further damage to the anal mucosa when passed.
      • Previous anorectal trauma (including anal surgery and obstetric history).
      • Associated symptoms (such as abdominal pain or weight loss).
      • Family history of possible underlying causes (such as colorectal cancer or inflammatory bowel disease).
  • Examine the person.
    • Assess the anal fissure. Ask the person to lie comfortably in a lateral position and gently part the buttocks. Anal spasm and pain may prevent full visualization of the fissure.
      • Acute anal fissures are typically superficial with well-demarcated edges.
      • Chronic anal fissures are wider and deeper with muscle fibres visible in the base. The edges are often swollen, and a skin tag may be visible at the end of the fissure.
      • Primary anal fissures are usually singular and occur in the posterior midline of the anus, although a few cases may be seen in the anterior midline (especially in women).
      • Secondary anal fissures may have an irregular outline, be multiple, or occur laterally — these require further investigation to identify the underlying cause.
    • Exclude a thrombosed haemorrhoid, which may present similarly.
    • If a secondary anal fissure is suspected, assess for features of an underlying cause, such as:
    • Consider the possibility of sexual abuse if a child has an anal fissure and possible causes (such as constipation or inflammatory bowel disease) have been excluded. 
    • Digital rectal examination is not recommended in primary care to diagnose anal fissure. 
      • Consider referral for examination under anaesthesia if the diagnosis is unclear or if spasm and pain make diagnosis difficult.
  • Be aware that anal fissure is less common in older adults — consider alternative diagnoses.

Basis for recommendation

These recommendations are largely based on clinical guidelines A quick guide to managing anal fissures [BPAC New Zealand, 2013], American College of Gastroenterology (ACG) clinical guideline Management of benign anorectal disorders [Wald, 2014], Clinical practice guideline for the management of anal fissures. Diseases of the colon and rectum [Stewart, 2017], a consensus document of the Spanish Association of Coloproctology [Arroyo, 2018], review articles [Fox, 2014; Foxx-Orenstein et al, 2014; Henderson and Cash, 2014; Schlichtemeier and Engel, 2016], [Sahebally, 2017; BMJ Best Practice, 2019; Newman, 2019; Boland, 2020; Gardner, 2020; Patkova, 2020; Jahnny, 2021], and a Cochrane systematic review [Nelson, 2012].

Atypical presentations

  • Most anal fissures are located at either the posterior midline of the anal canal (up to 90% of cases) or the anterior midline (especially in females). An atypical presentation, such as lateral location within the anal canal or multiple fissures, requires a high index of suspicion of an underlying condition such HIV, Crohn’s disease, syphilis, tuberculosis, and malignancy [Stewart, 2017; BMJ Best Practice, 2019; Jahnny, 2021].

Digital rectal examination

Considering child abuse

  • The recommendation on when to suspect child abuse is based on the National Institute for Health and Care Excellence (NICE) guideline Child maltreatment: when to suspect maltreatment in under 18s [NICE, 2017a].

What else might it be?

  • Anal pain with or without bright red rectal bleeding may also occur with thrombosed haemorrhoids.
  • Other causes of anal pain with or without bleeding include:
    • Inflammatory bowel disease.
    • Sarcoidosis.
    • Infection for example tuberculosis, HIV, or syphilis.
    • Malignancy for example anal carcinoma or lymphoma.
    • Peri-anal abscess.

Basis for recommendation

The information on differential diagnosis is based on expert opinion in review articles on anal fissure [Foxx-Orenstein et al, 2014; Henderson and Cash, 2014; Schlichtemeier and Engel, 2016; BMJ Best Practice, 2019; Jahnny, 2021].

Management

Scenario: Management of an anal fissure

From age 1 month onwards.

How should I manage a person with anal fissure in primary care?

  • Consider the need for referral.
    • Refer using a suspected cancer pathway referral (for an appointment within 2 weeks) if rectal cancer is suspected.
    • Refer to an appropriate specialist (with urgency dependant on clinical judgement) if another serious underlying cause, such as inflammatory bowel disease or a sexually transmitted infection (such as HIV infection), is suspected (for example if fissure looks atypical on examination).
    • Consider referring to a general or colorectal surgeon if anal fissure occurs in an elderly person.
  • For all people with anal fissure:
    • Ensure stools are soft and easy to pass.
      • If the anal fissure is caused by constipation, see the CKS topics on Constipation and Constipation in children for information on management.
      • If the person is not constipated, advise adequate dietary fibre intake by eating a balanced diet containing whole grains, fruits, and vegetables; this should be done gradually to minimize flatulence and bloating. Also advise that adequate fluid intake is particularly important with an increased fibre diet to maintain soft, well-lubricated stools and to prevent intestinal obstruction.
    • Give lifestyle advice to aid healing of the anal fissure. 
      • Discuss the importance of correct anal hygiene, especially in children. The anal region should be kept clean and dry to aid healing and avoid complications of anal fissure (such as infection or abscess).
      • Advise against 'stool withholding' and undue straining during bowel movements, both of which can worsen anal fissure. The national charity ERIC has useful information on managing stool withholding in children.
    • Manage pain.
      • Offer simple analgesia (paracetamol or ibuprofen) if there is prolonged burning pain following defecation. Avoid opioid analgesics as they can cause constipation and exacerbate symptoms.
      • Advise that sitting in a shallow, warm bath several times a day (if possible, particularly after a bowel movement) may help relieve pain.
      • For an adult with extreme pain on defecation, consider prescribing a short course (a few days) of a topical anaesthetic (lidocaine 5% ointment) for use before passing a stool. Advise the person to apply 1–2 mL when required.
  • For an adult with a primary anal fissure who has had symptoms for 1 week or more without improvement:
    • In addition to the lifestyle measures described above, consider prescribing rectal glyceryl trinitrate (GTN) 0.4% ointment (provided there are no contraindications) to aid healing.
    • Advise the person to apply twice a day for 6–8 weeks.
      • Around 25% of people experience headache as a side effect which may affect compliance.
      • GTN ointment should be avoided in children, and during pregnancy and breastfeeding, see the section on Prescribing for more information.
  • For people with secondary anal fissure for whom referral is not indicated:
    • Manage the underlying cause, where possible.
  • Give follow-up advice:
    • For a primary anal fissure:
      • In a child, advise the parents/carers to return if the fissure is unhealed after 2 weeks, or earlier if the child is in a lot of pain.
      • In an adult, review if the fissure is unhealed after 6–8 weeks, or earlier if needed (for example if the person develops intolerable adverse effects from rectal GTN ointment).
      • Advise all people that they should continue with the dietary and lifestyle measures when the fissure has healed to reduce the risk of recurrence.
    • For a secondary anal fissure, follow-up arrangements will depend on the underlying cause.
  • Patient information on anal fissure is available from:

Basis for recommendation

Arranging referral if serious underlying pathology is suspected
Managing secondary causes of anal fissure, where possible
  • This recommendation is based on what CKS considers to be good clinical practice
Ensuring stools are soft and easy to pass
Lifestyle measures to aid healing of anal fissure
Managing pain
Rectal glyceryl trinitrate (GTN) ointment
  • GTN acts as a nitric oxide donor, and there is some evidence that it can aid healing of anal fissure by relaxing the internal anal sphincter, resulting in reduced anal pressure and an improvement in blood flow [Altomare et al, 2011; Boland, 2020].
    • A Cochrane systematic review (search date August 2010) on non-surgical treatments for anal fissure (n = 5031) found that rectal GTN ointment was marginally but significantly better than placebo in healing anal fissure (48.9% compared with 35.5%) [Nelson, 2012].
  • CKS recommends considering prescribing rectal GTN 0.4% ointment if symptoms have been present for longer than 1 week without improvement as many acute anal fissures heal within 2 weeks (in some cases spontaneously) [Lund, 2006; BMJ Best Practice, 2019].
  • Expert opinion in review articles on the management of anal fissure is that treatment with GTN ointment should be continued for at least 6 weeks to allow re-epithelization of the fissure and reduce the risk of relapse [BPAC New Zealand, 2013]  [BMJ Best Practice, 2019; Newman, 2019].
  • Increase in dose of GTN has not been found to improve healing rates, but is associated with increased incidence of side effects [Stewart, 2017].
When to review children with primary anal fissure
  • This recommendation is based on what CKS considers to be good clinical practice.
  • Expert opinion in review articles is that delayed treatment of anal fissure in children can lead to a cycle of constipation, rectal bleeding, distress, and stool holding, as a result of pain during and after defecation [Klin, 2012; Patkova, 2020].
When to review adults with primary anal fissure
Reducing the risk of recurrence

How should I manage a person with an unhealed or recurrent anal fissure?

  • Following initial management:
    • If anal fissure is unhealed in a child after 2 weeks (or earlier if the child is in a lot of pain):
      • Seek specialist advice/refer to a paediatrician.
    • If anal fissure is unhealed in an adult after 6–8 weeks but the person is asymptomatic or has had notable symptomatic improvement, consider (based on clinical judgement):
      • Prescribing a second course of rectal glyceryl trinitrate (GTN) 0.4% ointment with review after a further 6–8 weeks, or
      • Discussion with/referral to colorectal surgery.
    • If anal fissure is unhealed in an adult after 6–8 weeks and there is no notable symptomatic improvement, confirm that rectal GTN ointment was used for 6–8 weeks.
      • If there was inadequate adherence to treatment with rectal GTN ointment (for example it was stopped early due to intolerable headache), seek specialist advice on alternatives (for example topical diltiazem 2% [unlicensed product]).
      • If there was adequate adherence to initial treatment, refer the person to a general or colorectal surgeon for investigation and treatment.
    • If anal fissure recurs after the initial episode has healed ask about continuation with dietary and lifestyle measures:
      • If adherence has been inadequate, reinforce the importance of doing so, and manage the anal fissure.
      • If adherence was adequate, refer the person to a general or colorectal surgeon for investigation and consideration of more intensive treatment.
    • If at any time an anal fissure appears atypical or scarring or skin tags develop — refer to secondary care for further investigation and management.

Basis for recommendation

Managing unhealed anal fissure in a child
  • This recommendation is based on what CKS considers to be good clinical practice.
  • Expert opinion in review articles is that delayed treatment of anal fissure in a child can lead to a cycle of constipation, rectal bleeding, distress, and stool holding, as a result of pain during and after defecation [Klin, 2012; Patkova, 2020].
Managing unhealed anal fissure in an adult
  • Acute primary anal fissures typically resolve within 6–8 weeks of conservative treatment [Lund, 2006; Zaghiyan, 2011; BPAC New Zealand, 2013; Henderson and Cash, 2014; Schlichtemeier and Engel, 2016].
  • Expert opinion in review articles on the management of anal fissure is that treatment with rectal glyceryl trinitrate (GTN) 0.4% ointment can be continued for a further 6–8 weeks if the fissure is unhealed but the person is reporting notable symptomatic improvement [BPAC New Zealand, 2013; Henderson and Cash, 2014; BMJ Best Practice, 2019].
  • The recommendation to seek advice from a specialist on use of topical diltiazem (unlicensed) if the person is unable to tolerate topical GTN due to adverse effects is based on expert opinion in review articles [Walsh, 2018; Gardner, 2020] and what CKS considers to be best practice.
  • Diltiazem is a calcium-channel blocker and vasodilator which increases blood flow to smooth muscles and relaxes muscle tone [NICE, 2013].
  • Evidence from a Cochrane systematic review (search date August 2010, n = 5031) [Nelson, 2012] and a subsequent systematic review (n = 481) [Sajid, 2013] suggests that topical diltiazem and rectal GTN ointment are equally effective for the management of anal fissure. However, topical diltiazem is associated with a lower incidence of headache and recurrent fissures.
Managing recurrent anal fissure where adherence to conservative measures has been inadequate
Managing recurrent anal fissure where adherence to conservative measures has been inadequate
  • This recommendation is based on what CKS considers to be good clinical practice.
Secondary care treatments
  • Expert opinion in a review article on the management of anal fissure is that although increased dietary fibre and topical treatments relieve symptoms and speed healing of acute fissures, they offer limited benefit in treating chronic anal fissures in particular where scarring is present [Fox, 2014; Walsh, 2018].
  • Secondary care treatment options for chronic and recurrent primary anal fissure may include rectal glyceryl trinitrate 0.4% ointment in children (unlicensed use in people younger than 18 years of age), topical diltiazem 2% (unlicensed product), botulinum toxin injection, and surgery [Altomare et al, 2011; Fox, 2014; Foxx-Orenstein et al, 2014; Sahebally, 2017; Stewart, 2017; Boland, 2020].

Prescribing information

Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information on contraindications, cautions, drug interactions, and adverse effects, see the electronic Medicines Compendium (eMC), or the British National Formulary (BNF).

Rectal glyceryl trinitrate 0.4% ointment

What are the contraindications and cautions with rectal glyceryl trinitrate ointment?

  • Do not prescribe rectal glyceryl trinitrate (GTN) 0.4% ointment to:
    • People with:
      • Postural hypotension, hypotension, or uncorrected hypovolaemia — the use of GTN in such states could cause severe hypotension or shock.
      • Increased intracranial pressure (for example head trauma or cerebral haemorrhage) or inadequate cerebral circulation. 
      • Migraine or recurrent headache — there is an increased risk of developing headache with treatment.
      • Aortic or mitral stenosis.
      • Hypertrophic obstructive cardiomyopathy. 
      • Constrictive pericarditis or pericardial tamponade. 
      • Marked anaemia.
      • Closed-angle glaucoma. 
    • People who are:
      • Younger than 18 years of age — the manufacturer states that rectal GTN 0.4% ointment is not recommended for use in this age group due to a lack of data on safety and efficacy.
      • Taking drugs that may interact such as phosphodiesterase type 5 (PDE5) inhibitors for example sildenafil and other long-acting GTN products, isosorbide dinitrate.
  • Prescribe rectal GTN 0.4% ointment with caution to:
    • People with:
      • Severe hepatic or renal disease. 
      • Cardiac disorders (such as acute myocardial infarction or heart failure) — careful clinical and haemodynamic monitoring must be used to avoid hypotension and tachycardia. 
    • People who are:
      • Elderly — they may be more susceptible to the development of postural hypotension. 
      • Pregnant — the manufacturer advises against the use of rectal GTN in pregnancy because animal studies are inconclusive about its effects on fetal and postnatal development. However, the British National Formulary (BNF) states that it is not known to be harmful during pregnancy.
      • Breastfeeding — the manufacturer advises against the use of rectal GTN in breastfeeding women due to a lack of evidence and potential harmful effects on a breastfed infant. However, the UK Specialist Pharmacy Services [Specialist Pharmacy Services, 2020] states that it is compatible with breastfeeding, but the woman should be advised to wash her hands immediately after use and before handling the infant.

[ABPI, 2020; BNF, 2021]

What adverse effects are associated with rectal glyceryl trinitrate ointment?

  • Dose-related headache is the most common adverse effect, experienced by more than half of all people using rectal glyceryl trinitrate (GTN) 0.4% ointment. 
    • In clinical trials of GTN 0.4% rectal ointment, the incidence of mild, moderate, and severe headache was 18%, 25%, and 20%, respectively. 
    • People with a previous history of migraine or recurrent headache are at a higher risk of developing headache during treatment.
    • Headache may be experienced after each application and is usually reversible on stopping treatment. It usually responds to treatment with simple analgesics (such as paracetamol and ibuprofen).
  • Other adverse effects include dizziness, light-headedness, blurred vision, nausea, and uncommonly, diarrhoea, anal discomfort, vomiting, rectal bleeding, pruritus, anal burning and itching, and tachycardia.
    • If bleeding associated with haemorrhoids increases, treatment should be stopped.
  • Rarely, hypotension may occur, causing dizziness, syncope, and light-headedness. Advise the person:
    • To get up slowly from lying or sitting down to minimize postural hypotension. This is particularly important for people taking diuretics.
    • That the hypotensive effects of GTN may be enhanced by alcohol.
  • As rectal GTN may cause dizziness, light-headedness, blurred vision, headache or tiredness in some people, especially on first use, the manufacturer recommends giving advice on driving or operating machinery.

[ABPI, 2020; BNF, 2021]

What drug interactions are associated with rectal glyceryl trinitrate ointment?

  • Possible drug interactions with rectal glyceryl trinitrate (GTN) ointment include:
    • Phosphodiesterase 5 inhibitors: concurrent use with sildenafil, tadalafil, and vardenafil is contraindicated as these drugs potentiate the hypotensive effects of GTN.
    • Other organic nitrates: concurrent treatment with other organic nitrates with nitric oxide donors (such as other long-acting GTN products, isosorbide dinitrate, and amyl- or butyl-nitrite) is contraindicated.
    • Other vasodilators: concurrent treatment with other vasodilators (including calcium-channel blockers and angiotensin-converting enzyme [ACE] inhibitors), beta-blockers, diuretics, tricyclic antidepressants, alcohol, and major tranquillizers may potentiate the hypotensive effects of GTN ointment.

[Preston, 2015; ABPI, 2020; BNF, 2021]

Supporting evidence

This CKS topic is largely based on expert opinion in guidelines, review articles, and a Cochrane systematic review on anal fissure. The rationale for the individual recommendations is discussed in the relevant basis for recommendation sections.

How this topic was developed

This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.

Search strategy

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of anal fissure.

Search dates

April 2016 - March 2021

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

  • exp Fissure in Ano/, (anal ADJ fissure).tw., (fissure ADJ2 ano).tw.
  • Exp anal fissure/
  • (nitroglycerin or nitrates or diltiazem or nifedipine or botulinum or fiber) and (anal fissure).ti,ab.

Sources of guidelines

Sources of systematic reviews and meta-analyses

  • The Cochrane Library:
    • Systematic reviews
    • Protocols
    • Database of Abstracts of Reviews of Effects
  • Medline (with systematic review filter)
  • EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

Sources of randomized controlled trials

  • The Cochrane Library:
    • Central Register of Controlled Trials
  • Medline (with randomized controlled trial filter)
  • EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

Sources of national policy

Patient experiences

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

  • Clinical accuracy.
  • Consistency with other providers of clinical knowledge for primary care.
  • Accuracy of implementation of national guidance (in particular NICE guidelines).
  • Usability.

Principles of the consultation process

  • The process is inclusive and any individual may participate.
  • To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
  • Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
  • Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
  • External reviewers are not paid for commenting on the draft topics.
  • Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
  • All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
  • All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

  • Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
  • Stakeholders identified from the following groups are invited to review draft topics:
    • Experts in the topic area.
    • Professional organizations and societies (for example, Royal Colleges).
    • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
    • Guideline development groups where the topic is an implementation of a guideline.
    • The British National Formulary team.
    • The editorial team that develop MeReC Publications.
  • Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

  • Topic selection
  • Scoping of topic
  • Selection of clinical scenarios
  • First draft internal review
  • Second draft internal review
  • External review
  • Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

  • Animal studies
  • Original research is not written in English

Possible exclusions for reviewed literature:

  • Sample size too small or study underpowered
  • Bias evident or promotional literature
  • Population not relevant
  • Intervention/treatment not relevant
  • Outcomes not relevant
  • Outcomes have no clear evidence of clinical effectiveness
  • Setting not relevant
  • Not relevant to UK
  • Incorrect study type
  • Review article
  • Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

  • Feasibility
    • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
  • Organizational and Financial Impact Analysis
  • Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
    • Eligible population
    • Current interventions
    • Likely uptake of new intervention or recommendation
    • Cost of the current or new intervention mix
    • Impact on other costs
    • Condition-related costs
    • In-direct costs and service impacts
    • Time dependencies
  • Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

  • Personal financial interests
  • Personal family interest
  • Personal non-financial interest
  • Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.

References

  • ABPI (2020) SPC for Rectogesic 4 mg/g Rectal Ointment. Electronic Medicines Compendium. Datapharm Communications Ltd. https://www.medicines.org.uk/emc
  • Altomare, D.F., Binda, G.A. and Canuti, S. et al (2011) The management of patients with primary chronic anal fissure: a position paper. Techniques in Coloproctology 15(2), 135-141. [Abstract] [Free Full-text]
  • Arroyo, A., Montes, E., Calderón, T., et al. (2018) Treatment algorithm for anal fissure. Consensus document of the Spanish Association of Coloproctology and the Coloproctology Division of the Spanish Association of Surgeons. Cir Esp 96(5), 260-267.
  • Bhardwaj, R. and Parker, M.C. (2007) Modern perspectives in the treatment of chronic anal fissures. Annals of the Royal College of Surgeons of England 89(5), 472-478. [Abstract] [Free Full-text]
  • BMJ Best Practice (2019) Anal fissure: symptoms, diagnosis and treatment. https://bestpractice.bmj.com [Free Full-text]
  • BNF (2021) British National Formulary. BMJ Group and Pharmaceutical Press. https://bnf.nice.org.uk
  • Bobkiewicz, A., Francuzik, W., Krokowicz, L., et al. (2016) Botulinum toxin injection for treatment of chronic anal fissure: is there any dose-dependent efficiency? World Journal of Surgery 40(12), 3064-3072.
  • Boland, P.A., Kelly, M.E., Donlon, N.E., et al. (2020) Management options for chronic anal fissure: a systematic review of randomised controlled trials. International Journal of Colorectal Disease 35(10), 1807-1815.
  • BPAC NZ (2013) A quick guide to managing anal fissures. Best Practice Journal 52, 16-17. [Free Full-text]
  • Fox, A., Tietze, P.H. and Ramakrishnan, K. (2014) Anorectal conditions: anal fissure and anorectal fistula. FP Essentials 419, 20-27.
  • Foxx-Orenstein, A.E., Umar, S.B. and Cromwell, M.D. (2014) Common anorectal disorders. Gastroenterology & Hepatology 10(5), 294-301.
  • Gardner, I.H., Siddharthan, R.V. and Tsikitis, V.L. (2020) Benign anorectal disease: hemorrhoids, fissures, and fistulas. Annals of Gastroenterology 33(33), 9-18.
  • Henderson, P.K. and Cash, B.D. (2014) Common anorectal conditions: evaluation and treatment. Current Gastroenterology Reports 16(10), 10-13. [Abstract]
  • Jahnny, B. and Ashurst, J.V. (2021) Anal fissures. Treasure Island (FL), StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK526063
  • Klin, B., ABu-Kishk, I., Efrati, Y. and Lotan, G. (2012) Nifedipine gel with lidocaine in the treatment of anal fissure in children: a pilot study and review of the literature. In: Ozdemir, O. (Eds.) Complementary pediatrics. New York: InTech, 53-70.
  • Lund, J.N., Nystrom, P.O., Coremans, G., et al. (2006) An evidence-based treatment algorithm for anal fissure. Techniques in Coloproctology 10(3), 177-180. [Abstract]
  • Madalinski, M.H (2011) Identifying the best therapy for chronic anal fissure. World Journal of Gastrointestinal Pharmacology and Therapeutics 2(2), 9-16. [Abstract] [Free Full-text]
  • Mapel, D.W., Schum, M. and Von Worley, A. (2014) The epidemiology and treatment of anal fissures in a population-based cohort. BMC Gastroenterology 14(129).
  • MHRA (2015) Summary of product characteristics: lidocaine 5% ointment. Medicines & Healthcare products Regulatory Agency. http://www.mhra.gov.uk
  • Nelson, R.L., Thomas, K., Morgan, J. and Jones, A. (2012) Non surgical therapy for anal fissure (Cochrane Review). The Cochrane Library. John Wiley & Sons, Ltd. http://www.thecochranelibrary.com [Free Full-text]
  • Newman, M. and Collie, M. (2019) Anal fissure: diagnosis, management, and referral in primary care. British Journal of General Practitioners 69(685), 409-410.
  • NICE (2013) Chronic anal fissure: 2% topical diltiazem hydrochloride. National Institute for Health and Care Excellence. http://www.nice.org.uk [Free Full-text]
  • NICE (2017a) Child maltreatment: when to suspect maltreatment in under 18s. National Institute of Health and Care Excellence. http://www.nice.org.uk [Free Full-text]
  • NICE (2017b) Constipation in children and young people: diagnosis and management. National Institute of Health and Care Excellence. http://www.nice.org.uk [Free Full-text]
  • Patkova, B. and Wester, T. (2020) Anal fissure in children. European Journal of Pediatric Surgery 30(5), 391-394.
  • Preston, C.L. (Eds.) (2015) Stockley's drug interactions 2015: pocket companion. London: Pharmaceutical Press.
  • Sahebally, S.M., Ahmed, K., Cerneveciute, R., et al. (2017) Oral versus topical calcium channel blockers for chronic anal fissure-a systematic review and meta-analysis of randomized controlled trials. International Journal of Surgery 44, 87-93.
  • Sajid, M.S., Whitehouse, P.A., Sains, P. and Baig, M.K. (2013) Systematic review of the use of topical diltiazem compared with glyceryltrinitrate for the nonoperative management of chronic anal fissure. Colorectal Disease 15(1), 19-26. [Abstract]
  • Schlichtemeier, S. and Engel, A. (2016) Anal fissure. Australian Prescriber 39, 14-17. [Free Full-text]
  • Specialist Pharmacy Services (2020) Safety in lactation: drugs for rectal and anal disorders. NHS. https://www.sps.nhs.uk [Free Full-text]
  • Stewart, D.B., Gaertner, W.G., Migaly, J., et al. (2017) Clinical practice guideline for the management of anal fissures. Diseases of the colon and rectum. ASCRS. https://fascrs.org [Free Full-text]
  • UKMi (2015) Is topical glyceryl trinitrate for anal fissure compatible with breastfeeding? Specialist Pharmacy Service. http://www.ukmi.nhs.uk [Free Full-text]
  • Wald, A., Bharucha, A.E., Cosman, B.C. and Whitehead, W.E. (2014) ACG clinical guideline: management of benign anorectal disorders. American Journal of Gastroenterology 109(8), 1141-1157. [Abstract]
  • Walsh, C.J., Delaney, S. and Rowlands, A. (2018) Rectal bleeding in general practice: new guidance on commissioning. British Journal of General Practitioners 68(676), 514-515.
  • Zaghiyan, K.N. and Fleshner, P. (2011) Anal fissure. Clinics in Colon and Rectal Surgery 24(1), 22-30. [Abstract]
Change privacy settings