treating chronic anal fissure in view of outcome, cost effectiveness and patient compliance.
6.2 Review of literature
In 2001Jan, Evans.J, Luch A, and Hewett P, gave a comparative study of the
management of chronic anal fissure with glyceryl nitrate versus lateral internal
sphincterotomy. Glyceryl trinitrate has been shown to be an effective treatment for chronic
anal fissure. It decreases anal tone and ultimately heals anal fissures. Glyceryl trinitrate paste
heals the majority of chronic anal fissures. However, a significant minority have little
improvement or develop side effects and require conventional surgicaltreatment. Poor
compliance with prescribed treatment often contributes to non-healing. In addition, some
fissures which initially heal with glyceryl trinitrate paste recur and require further treatment.
Glyceryl trinitrate treatment is labor intensive for patients and physicians and has not been
shown to be superior to lateral sphincterotomy.1
In 2005, Laurence Russel Sands conducted a randomized, double –blind study of
intra- anally applied nitroglycerin ointment (Anogesic) in 304 patients with chronic anal
fissures. The patients were randomly assigned to one of eight treatment regimens (0.0. 0.1,
0.2, 0.4 percent nitroglycerin ointment applied twice or three times per day), for up to eight
weeks. The subjects assessed pain intensity daily by completing a diary containing a visual
analog scale for average pain intensity for the day, the worst pain intensity for the day, and
pain intensity at the last defecation, and in the results thus obtained there were no significant
differences in fissure healing among any of the treatment groups; all groups, including
placebo had a healing rate of approximately 50%. Hence the treatment with 0.4%(1.5mg)
nitroglycerin ointment was associated with a significant (P<0.0002) decrease in average pain
intensity compared with vehicle as assessed by patients with a visual analog scale. Treatment
was well tolerated, with only 3.29 percent of patients discontinuing treatment because of
headache. Headaches were the primary adverse event and were dose related. Therefore he
concluded that Nitroglycerin ointment did not alter healing but significantly and rapidly
reduced the pain associated with chronic anal fissures.2
In Jan 2005,Haq Z, Rahman M, Chowdhary RA, said that Internal anal
sphincterotomy is the gold standard surgical treatment which lowers the resting anal
pressure and effectively heals the majority of fissures. However the post operative period
may be marked by surgical risks, complications and late incidence of incontinence that is
sometimes permanent. These complications have led to a search for alternative therapies for
the treatment of chronic anal fissure. Chemical sphincterotomy has been tried using a variety
of novel agents including topical glyceryl trinitrate (GTN), calcium channel
blockers such as nifedipine or diltiazem and botulinum toxin. Some of these agents
were found to be effective in healing chronic anal fissure with negligible side effects and are
now considered as first line treatment for chronic anal fissure.3
In 2005, Dec,García-Granero E and others in a Spanish article published that
chemical sphincterotomy using Nitroglycerin or Diltiazem or Botulinum toxin should be the first option in patients with a high risk of incontinence. "Open" or "closed" lateral internal sphincterotomy performed in the ambulatory setting with local anesthesia can currently be
considered the ideal treatment of Chronic Anal Fissure refractory to conservative measures so long as the patient is informed about the risk of minor incontinence. This procedure provides
rapid and permanent recovery in more than 95% of patients. There is evidence demonstrating that the incontinence rate is related to the extent of the lateral internal sphincterotomy and consequently the extent of this procedure should be reduced to the length of the fissure.4 In 2007, E.E. Collins and J.N. Lund, said that all methods of treatment aim to
reduce the anal sphincter spasm associated with chronic anal fissure. Surgical techniques
have been used for over 100years with success. Lateral internal sphincterotomy remains the
surgical treatment of choice for many practioners. Postoperative impairement of continence
remains controversial. Recently, less invasive methods of treatment have been explored.
Topical nitrates, calcium channel blockers and botulinum toxin are established treatments.
These and other non-surgical treatments are described in this review.5
In 2007, Bharadwaj R, Parker MC, obtained data from Medline publication
citing ‘anal fissure’. Manual cross referencing of salient articles were conducted and they
have sought to highlight various controversies in the management of anal fissures. According
to thempharmacological agents such as glyceryl trinitrate (GTN), diltiazem and botulinum
toxin have been subjected to most scrutiny. Sphincterotomy is indicated for unhealed fissures.
Most chronic anal fissures are associated with a raised internal anal sphincter (IAS) pressure
and reduced vascular perfusion at the base. Current treatment has aimed at reducing resting
anal pressure by diminishing sphincter tone and improving blood supply at the site of the
fissure, thus promoting the healing rate. Sphincterotomy induces a sustained reduction of
maximum resting anal pressure. The largest review of the sequelae of internal
sphincterotomy for chronic fissurein ano,showed rates of flatus incontinence in 715
patients, occurring ‘sometimes’ to ‘infrequently’ in (35.7%), faecal urgency in (4.9%) and
soiling in (21.2%). Incontinence may be minimised by a ‘tailored sphincterotomy’ where the
sphincter is divided to the length of the fissure; this does not appear to compromise the
established therapies. This paper recommends initial pharmacological therapy with GTN or
Diltiazem ointment with Botulinum toxin as a possible second line pharmacological therapy.
Perineal support may offer a new dimension in improving healing rates. Lateral
Sphincterotomy should be offered if pharmacological therapy fails. New therapies are not
suitable as first line treatments, though they can be considered if conventional treatment
In 2010, Afsheen zafar, Ahmed Rehman and others did a comparative study
between the characteristics of the chronic anal fissure which healed with pharmacological
agents with those which ultimately required sphincterotomy. This cross sectional
comparative study was performed on 180 patients who presented with chronic anal fissures.
Out of them, 31 patients underwent lateral internal sphincterotomy (LIS) due to non-healing
or recurrence despite at least 6 weeks therapy of 0.2% Glyceryl trinitrate (GTN) ointment.
The frequency of multiplicity and any association with skin tags or hemorrhoids were noted
in two groups using chi-square test for statistical analysis. The results thus obtained had
associated skin tag, 23 had hemorrhoids and 12 had multiple fissures. There was significant
association of skin tags with fissures undergoing LIS (P<0.001). Therefore concluded that
association with a sentinel skin tag is a predictor of failure of medical treatment for chronic
In 2010, Gouda m, ellabban, Galal H. El-Gazzaz, and emad N. hokKam Dr, did a
comparative study of the effectiveness of local glyceryl trinitrate (GTN) versus internal
sphincterotomy in the management chronic anal ﬁssure. According to this study, 40 patients
were treated with topical GTN 0.2% on liposomal base applied to the anoderm twice daily
and 40 patients were treated with internal sphincterotomy. We compare the effectiveness of
both techniques in the management chronic anal ﬁssure. The Results thus obtained were: In
group 1, healing of ﬁssures occurred in 85% of patients after 8 weeks therapy. Headache as a
side effect developed in 65% of patients. In group 2, healing occurred in 97.5% of patients
after 8 weeks. Incontinence to ﬂatus occurred in 3 patients (7.5%), mild soiling in 2 patients
(5%) and one patient developed wound infection. All complications were temporary except
for one patient with persistent incontinence to ﬂatus. At the end of 8 weeks both groups were
equal in pain scoring. They concluded that Topical GTN should be the initial treatment in
chronic anal ﬁssure while internal sphincterotomy may be reserved for patients who not
respond to GTN therapy and those with severe pain. (as healing is faster with
6.3 Aims and objectives of the study
The aims and objectives of the study are
To compare the efficacy of 0.2% Glyceryl Trinitrate ointment versus Lateral
internal sphincterotomy in the treatment of chronic anal fissure.
2. To compare the disadvantages of 0.2% Glyceryl Trinitrate ointment versus
Lateral internal sphincterotomy in the management of chronic anal fissure.
7. MATERIALS AND METHODS
7.1 Source of data
The cases who will be presenting in various surgical units in K.R.Hospital, Mysore, attached to Mysore Medical College And Research Institute, Mysore, from December 2011 to May 2013 will form the material of the study. During this period cases which are selected at random will be studied in detail. This study will be of 100 cases.
7.2. Methods of collection of data
50 patients will be treated with 0.2% Glyceryl Trinitrate ointment and 50 patients will be
treated with Lateral internal sphincterotomy for management of chronic anal fissure will be
selected for study. Observations will be recorded at 2 weeks, 6 weeks and 12 weeks of
follow up period, regarding symptoms like pain, bleeding and healing and also for side
effects like headache in GTN group and flatus, fecal incontinence in surgical groups. Data
will be collected in proforma and will be analyzed.
7.3. Inclusion Criteria
Chronic anal fissure with hypertonic anal sphincter.
Patients on nitrates for medical conditions like IHD.
Fissures in pregnant women.
Anal fissures with Inflammatory Bowel Disease and Crohn’s disease.
Radiological study – Chest X-ray, ultrasound abdomen (if required).
Specific investigations – Proctoscopy.
7.5. Has ethical clearance been obtained from your institution in case of 7.4?
Yes, obtained (copy enclosed).
8. List of References
1. Evans.J, Luch A, and Hewett P, “Glyceryl Nitrate versus lateral anal sphincterotomy for
Chronic anal fissure: prospective and randomized trial”. English abstract, Dis Colon
Rectum 2001.Jan; 44(1):93-7.
2. Laurence Russel Sands, “0.4% nitroglycerin ointment in the treatment of chronic anal
fissure Pain: a viewpoint by Laurence R. Sands.”. university of Miami, school of
Medicine, Miami, Florida, USA. Drugs 2006; 66(3):350-2.
3. Haq Z, Rahman M, Chowdhary RA, “Chemical sphincterotomy-first line of treatment for
Chronic anal fissure”. English abstract from Mymensingh Med J. 2005 Jan;14(1):88-90.
4. García-Granero E and others, “Treatment of chronic anal fissure”. An article in spanish,
Cir Esp. 2005 Dec; 78 Suppl 3:24-7.
5. E.E. Collins and J.N. Lund, “A review of chronic anal fissure management”. An English
Abstract from the University of Nottingham Medical School, UK. Tech Coloproctol.
2007 Sep; 11 (3):209-23. Epub 2007 Aug 3.
6. Bharadwaj R, Parker MC, “Modern Perspectives in the Treatment of Chronic Anal
Fissures”. An English abstract from The US nation library of Medicine. Ann R Coll
Surg Engl. 2007 July; 89(5):472-478.
7. Sanju Dhawan, Ph.D. and Sunny Chopra, “Nonsurgical Approaches for the Treatment of
Anal Fissures”. An English abstract from the American journal of Gastroentrology.
8. Aaron Poh, Kok-Yang Tan, Francis sew- Cheon, “Innovations in chronic anal fissure
treatment: A systematic review”. An English abstract from the US National library of
medicine. World J Gastrointest Surg. 2010 July;2(7):231-241.
9. Afsheen zafar, Ahmed Rehman, “Chronic anal fissures-association with sentinel skin
tag”. An English abstract from Rawal Medical Journal. RMJ, 2010; 35(2):177-179.
10. Gouda m, ellabban, Galal H. El-Gazzaz, and emad N. hokKam Dr, “Is Topical
Nitroglycerin Superior to Internal Sphincterotomy in the management of Chronic Anal
Fissure”. An English abstract from, “World Journal of Colorectal Surgery: Vol.2: Iss.1,
9. Signature of the candidate :
10. Remarks of the Guide : Chronic anal fissure is a common surgical Problem among the population. Atleast 10 cases are treated on OPD basis and minimum 3 cases will be posted in the routine OT list. Hence this comparative study is very important and beneficial to the community.
11. Name and Designation of
11.1 Guide : Prof. Dr. Shivananda
M.S. (General Surgery)
Professor, Department of Surgery,
Mysore Medical College and Research Institute,
11.2 Signature of Guide :
11.3 Head of the Department : Prof. Dr. M. A. Shariff