Anal Fissure Clinical Trials, Diagnosis, and Treatment

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Anal Fissure

Anal fissure is an unnatural crack or tear in the anus skin. As a fissure, these tiny tears may show as bright red rectal bleeding and cause severe periodic pain after defecation. The tear usually extends from the anal opening and located posteriorly in the midline. This location is probably because of the relatively unsupported nature of the anal wall in that location.

Current Research

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Causes

Most anal fissures are caused by stretching of the anal mucosa beyond its capability. Various causes of this fissure include:

Straining to defecate, especially if the stool is hard and dry
Severe and chronic constipation
Severe and chronic diarrhea
Crohn's disease and ulcerative colitis
Tight sphincter muscles
Anal intercourse

Many acute anal fissures will heal spontaneously. Some fissures become chronic and will not heal. The most common cause for this is spasm of the internal anal sphincter muscle. This spasm causes poor blood flow to the anal mucosa, hence producing an ulcer which does not heal since it is deprived of normal blood supply.

Anal fissures are common in women after childbirth, and following constipation in infants.

Symptoms

The symptoms of anal fissure include:

Pain during, and even hours after, defecation
Visible tear in the anus
Blood on the stool or on toilet paper or toilet bowl
Constipation
Burning, possibly painful itching
A tearing sensation during defecation, sometimes described as "like passing glass".

Prevention

In infants under one year old, frequent diaper change can prevent anal fissure. For Adults, the following can help prevent fissure:

Treating constipation by eating food rich in dietary fiber, avoiding caffeine (which can cause dehydration), drinking a lot of water and taking stool softener.
Treating diarrhea promptly.
Lubricating the anal canal with KY Jelly or other water-based lube (petroleum jelly is not recommended because it can harbor harmful bacteria).
Avoiding straining or prolonged sitting on the toilet.
Using a moist wipe instead of perfumed and harsh toilet paper.
Keeping the anus dry and hygienic.
When using Analpram (cream) do not use the dispenser which can injure the area. Instead use a finger to insert a pea size amount of cream.
Carmex lip ointment also helps and is much less expensive than Analpram ($70.00 small tube).

Treatment

For many years up until 1995, customary treatment included warm baths, topical anesthetics, stool bulking agents, mechanical anal stretching, and, sometimes, surgery. In 1995, doctors began using nitroglycerine cream (topical 1 percent isosorbide dinitrate) but found it less acceptable for long-term use due to patients developing a tolerance to the drug.[1] In 1998, Italian researchers reported injecting botulinum toxin into the anal sphincter to promote healing by relieving anal spasm through relaxation of the muscle.

Symptomatic

Most anal fissures are shallow or superficial (less than a quarter of inch or 0.64 cm deep). These fissures self-heal within a couple of weeks. Furthermore, treatment used for hemorrhoid such as eating a high-fiber diet, using stool softener, taking pain killer and having a sitz bath can help.

Paediatric

Anal fissures in infants usually self-heal without anything more than frequently changing diapers and treating constipation if the cause.

Chemical Sphincterotomy

Painful deep chronic fissures, on the other hand, will not heal because of poor blood supply caused by sphincter spasm. Traditionally surgical operations were required which are both painful and associated with various longterm complications, particularly incontinence in a small proportion of cases. Local application of medications to relax the sphincter muscle, thus allowing the healing to proceed, was first proposed in 1994 with nitroglycerine ointment, in 1999 with nifedipine ointment, and the following year with topical diltiazem. Branded preparations are now available of topical nitroglycerine ointment (Rectogesic as 0.2% in Australia and 0.4% in UK) and diltiazem 2% (Anoheal in UK although still in Phase III development). Botulinum toxin injection, administered by colorectal surgeons, can also be used to relax the sphincter muscle and its use for this condition was first investigated in 1993. Combination of medical therapies may offer up to 98% cure rates, These medical treatments are used as first line therapy in treating chronic anal fissures, although a Cochrane Collaboration review of published research has questioned the effectiveness of medical treatments compared to surgery.

Surgical Sphincterotomy

Surgical intervention may be required for persisting deep anal fissures unresponsive to the above conservative measures. Procedures include:

Internal lateral sphincterotomy or excising a portion of the sphincter
Anal dilation or stretching of the anal canal is no longer recommended because of the unacceptably high incidence of fecal incontinence. In addition, anal stretching can increase the rate of flatus incontinence.

Despite the high success rate of these surgical procedures (~95%), there are potential side effects, which include: risks from anesthesia, infection and anal leakage (fecal incontinence).

(adapted from Wikipedia, the free encyclopedia http://en.wikipedia.org/wiki/Anal_fissure)

Findings From Current Research

Quality of Extemporaneously Compounded Nitroglycerin Ointment

Authors: Azarnoff DL, Lee JC, Lee C, Chandler J, Karlin D.

D.L. Azarnoff Associates, LLC, Burlingame, California 94010-2011, USA. dan@azarnoffassociates.com

PURPOSE: Published clinical trials support the use of 0.2 to 0.4 percent nitroglycerin ointment for the treatment of an anal fissure, although no product is yet available in the United States. In 2004, 84,000 prescriptions were written for compounded nitroglycerin ointment. This study was designed to evaluate the quality of extemporaneously compounded nitroglycerin ointment. METHODS: Prescriptions for 0.3 percent nitroglycerin ointment were filled at retail pharmacies and shipped to analytical laboratory for analysis by their validated method. RESULTS: Five of 24 (20.8 percent) samples did not meet the United States Pharmacopoeia requirement for content uniformity of 90 to 110 percent and< 6 percent relative standard deviation. Seven of 24 samples (29.2 percent) were subpotent based on the United States Pharmacopoeia requirement of 90 to 115 percent of label claim, and 1 sample was suprapotent. When considered for potency and/or content uniformity, 11 of 24 (45.8 percent) were misbranded and poor quality. CONCLUSIONS: Forty-six percent of the nitroglycerin ointment products compounded by 24 pharmacies did not meet the United States Pharmacopoeia specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues regarding whether patients are put at undue risk relative to the relief of anal fissure pain. The pain associated with chronic anal fissure is severe, often debilitating, and may affect the patient's ability to work.

Journal: Dis Colon Rectum. 2007 Apr;50(4):509-16.
Adapted from PubMed; click here to access full journal article.

The Safety and Efficacy of a Mixture of Honey, Olive Oil, and Beeswax for the Management of Hemorrhoids and Anal Fissure: A Pilot Study

Authors: Al-Waili NS, Saloom KS, Al-Waili TN, Al-Waili AN.

Al-Waili's Foundation for Science and Trading, New York, USA. noori786@yahoo.com

We have found that a mixture of honey, olive oil, and beeswax was effective for treatment of diaper dermatitis, psoriasis, eczema, and skin fungal infection. The mixture has antibacterial properties. A prospective pilot study was conducted to evaluate the therapeutic effect of topical application of the mixture on patients with anal fissure or hemorrhoids. Fifteen consecutive patients, 13 males and 2 females, median age 45 years (range: 28-70), who presented with anal fissure (5 patients) or first- to third-degree hemorrhoids (4 with first degree, 4 with second degree, and 2 with third degree), were treated with a 12-h application of a natural mixture containing honey, olive oil, and beeswax in ratio of 1:1:1(v/v/v). Bleeding, itching, edema, and erythema were measured using a scoring method: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. The pain score was checked using a visual analog scale (minimum = 0, maximum = 10). Efficacy of treatment was assessed by comparing the symptoms' score before and after treatment; at weekly intervals for a maximum of 4 weeks. The patients were observed for evidence of any adverse effect such as appearance of new signs and symptoms, or worsening of the existing symptoms. The honey mixture significantly reduced bleeding and relieved itching in patients with hemorrhoids. Patients with anal fissure showed significant reduction in pain, bleeding, and itching after the treatment. No side effect was reported with use of the mixture. We conclude that a mixture of honey, olive oil, and beeswax is safe and clinically effective in the treatment of hemorrhoids and anal fissure, which paves the way for further randomized double blind studies.

Journal: ScientificWorldJournal. 2006 Feb 2;6:1998-2005.
Adapted from PubMed; click here to access full journal article.

Non Surgical Therapy for Anal Fissure

Authors: Nelson R.

Northern General Hospital, Department of General Surgery, Herries Road, Sheffield, UK. rick.nelson@sth.nhs.uk

BACKGROUND: Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently, pharmacologic methods that relax the anal smooth muscle, to accomplish reversibly what occurs in surgery, have been used to obtain fissure healing. OBJECTIVES: To assess the efficacy and morbidity of various medical therapies for anal fissure. SEARCH STRATEGY: Search terms include "anal fissure randomized". Timing from 1966 to May 2006. Further details of the search below. SELECTION CRITERIA: Studies in which participants were randomized to a non-surgical therapy for anal fissure. Comparison groups may include an operative procedure, an alternate medical therapy or placebo. Chronic fissure, acute fissure and fissure in children are included in the review. Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded. DATA COLLECTION AND ANALYSIS: Data were abstracted from published reports and meeting abstracts, assessing method of randomization, blinding, "intention to treat" and drop-outs, therapies, supportive measures (applied to both groups), dosing and frequency and cross-overs. Dichotomous outcome measures included Non-healing of the fissure (a combination of persistence and recurrence), and Adverse events (including incontinence, headache, infection, anaphylaxis). Continuous outcome measures included measures of pain relief and anorectal manometry. MAIN RESULTS: 48 different comparisons of the ability of medical therapies to heal anal fissure have been reported in 53 RCTs. Eleven agents were used (nitroglycerin ointment (GTN), isosorbide dinitrate, Botulinum toxin (Botox), diltiazem, nifedipine (Calcium channel blockers or CCBs), hydrocortisone, lignocaine, bran, minoxidil, indoramin, and placebo) as well as anal dilators and surgical sphincterotomy.GTN was found to be marginally but significantly better than placebo in healing anal fissure (48.6% vs. 37%, p < 0.004), but late recurrence of fissure was common, in the range of 50% of those initially cured. Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events. No medical therapy came close to the efficacy of surgical sphincterotomy, though none in these RCTs was associated with the risk of incontinence. AUTHORS' CONCLUSIONS: Medical therapy for chronic anal fissure, acute fissure and fissure in children may be applied with a chance of cure that is marginally better than placebo, and, for chronic fissure in adults, far less effective than surgery.

Journal: Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431.
Adapted from PubMed; click here to access full journal article.

Subcutaneous Fissurotomy: A Novel Procedure for Chronic Fissure-in-ano. A Review of 109 Cases

Authors: Pelta AE, Davis KG, Armstrong DN.

Georgia Colon & Rectal Surgical Clinic, 5555 Peachtree Dunwoody Road, Suite 206, Atlanta, Georgia, USA, GACRS@aol.com.

PURPOSE: The constant presence of a narrow subcutaneous tract extending caudad to chronic fissures-in-ano is reported. The efficacy of surgically unroofing this tract (subcutaneous fissurotomy) without sphincterotomy was evaluated. METHODS: By using a narrow-gauge, hooked probe, a constant, midline subcutaneous tract was identified extending from the caudad aspect of chronic anal fissures. These tracts are present within the sentinel tag, when present, and extend up to 1 cm caudad to the fissure in the subcutaneous plane. A proximal connection with the dentate line in the submucous plane also was identified. Surgically unroofing the tract (subcutaneous fissurotomy) resulted in significant widening of the distal anal canal, rendering internal sphincterotomy unnecessary. A 32-month prospective evaluation of this new technique was performed. Inclusion criteria included patients with chronic anal fissures that had failed conservative therapy, including topical agents. In each case, the tract was identified and surgically laid open along its entire length. No internal sphincterotomy was performed in any patient. Postoperatively, patients were instructed to apply topical 10 percent metronidazole t.i.d. The need for repeat surgery and/or subsequent internal sphincterotomy was recorded. RESULTS: A total of 109 patients were enrolled during the study period. Median follow-up was 12 months. During the study period, two patients (1.8 percent) required repeat surgery for persistent symptoms at 3 and 12 months postoperatively. No change in continence was reported in any patient. CONCLUSIONS: Laying open the subcutaneous tract has a very high success rate and a low incidence of repeat surgery. This finding introduces a new debate relating to the etiology of fissure-in-ano and makes routine internal sphincterotomy unnecessary.

Journal: Dis Colon Rectum. 2007 Aug 22
Adapted from PubMed; click here to access full journal article.

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