Through proper channel. Respected Sir

Dr. Dayananda Kumar. N.H

Post-graduate in General Surgery

Department of General Surgery

Mysore Medical College & Research Institute

Mysore.

The Registrar (Evaluation)

Rajiv Gandhi University of Health Sciences

Bangalore.

Subject: Submission of Synopsis titled, “COMPARATIVE STUDY OF LATERAL SPHINCTEROTOMY AND NITROGLYCERIN OINTMENT APPLICATION IN THE TREATMENT OF CHRONIC FISSURE IN ANO”.

I am hereby submitting the above titled synopsis (4 copies) as mentioned above, so kindly accept my application and do the needful.

Thanking You, Yours faithfully

Forwarded to Dean and Director, MMC & RI, Mysore for further needful action.

Date:

Place:

Department of Surgery

Chronic Anal Fissure is a common and distressing problem, the

incidence of which is probably higher than recorded. There is a progress in the understanding

of the etiopathogenesis of this entity and the changing trend in its management approach. The

method of treating this pathology should preferably be the one that results in optimal clinical

outcome, less painful and patient friendly.

Commonly lateral internal sphincterotomy and nitroglycerin ointment

local application remains the popular methods of treating this condition. But each method

has got its own advantages and disadvantages.

There is a need for study to compare these two common methods of

In 2001Jan, Evans.J, Luch A, and Hewett P, gave a comparative study of the

heals the majority of chronic anal fissures. However, a significant minority have little

improvement or develop side effects and require conventional surgical treatment. 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

pharmacological therapies such as glyceryl trinitrate (GTN), Diltiazem ointment and

Botulinum toxin provide a relatively non-invasive option, but with higher recurrence rates.

Lateral sphincterotomy remains the gold standard for treatment. New therapies include

perineal support devices, Gonyautoxin injection, fissurectomy, fissurotomy, sphincterolysis,

and flap procedures. Further research is required comparing these new therapies with existing

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

fails.⁸

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

anal fissure.⁹

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

sphincterotomy).¹⁰

6.3 Aims and objectives of the study

The aims and objectives of the study are

1. 
   To compare the efficacy of 0.2% Glyceryl Trinitrate ointment versus Lateral
   

internal sphincterotomy in the treatment of chronic anal fissure.

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.

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.

1. 
   Patients on nitrates for medical conditions like IHD.
   

2. 
   Fissures in pregnant women.
   

3. 
   Anal fissures with Inflammatory Bowel Disease and Crohn’s disease.
   

4. 
   Patients with immunocompromised state.
   

Yes, on the patients.

1. 
   Blood – Hb%, BT, CT, TC, DC, ESR, RBS, Blood urea, serum creatinine.
   

2. 
   Urine – Albumin, Sugar, Microscopy
   

3. 
   Radiological study – Chest X-ray, ultrasound abdomen (if required).
   

4. 
   ECG.
   

5. 
   Specific investigations – Proctoscopy.
   

Yes, obtained (copy enclosed).

1. Evans.J, Luch A, and Hewett P, “Glyceryl Nitrate versus lateral anal sphincterotomy for

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,

Article 9.



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

Professor, Department of Surgery,

Mysore Medical College and Research Institute,

Mysore.

11.3 Head of the Department : Prof. Dr. M. A. Shariff

Professor, Department of Surgery,

Mysore Medical College and Research Institute,

Mysore.

12.1. Remarks of the Dean and Director:

12.2. Signature of the Dean and Director:

ETHICAL COMMITTEE CLEARANCE

1. 
   TITILE OF THE DISSERTATION : Comparative study of lateral sphincterotomy
   

2. 
   NAME OF THE CANDIDATE : Dr. DAYANANDA KUMAR.N.H.
   

3. 
   SUBJECT : M.S. GENERAL SURGERY.
   

Professor, Department of Surgery,

Mysore Medical College and Research Institute,

Mysore.

(if not approved, suggestion) :

Medical Superintendent PROFESSOR AND HOD

K.R.Hospital, Mysore Department Of Surgery, K.R.Hospital, Mysore

Medical Superintendent PROFESSOR AND HOD

Cheluvamba Hospital, Mysore Department Of Medicine, K.R.Hospital, Mysore

Medical Superintendent LAW EXPERT

PKTB&CD Hospital, Mysore