Through proper channel. Respected Sir



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From,

Dr. Dayananda Kumar. N.H

Post-graduate in General Surgery

Department of General Surgery

Mysore Medical College & Research Institute

Mysore.


To,

The Registrar (Evaluation)

Rajiv Gandhi University of Health Sciences

Bangalore.



Through proper channel.

Respected Sir,

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



(DR. DAYANANDA KUMAR.N.H)

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

Date:

Place:


Professor and Head

Department of Surgery





RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION



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

AND ADDRESS Door no.44, 2nd cross, K .E. B. Colony,



  1. NAME OF THE INSTITUTION : Mysore Medical College & Research



Institute, Mysore - 570021






  1. COURSE OF STUDY AND SUBJECT : M. S. General Surgery



  1. DATE OF ADMISSION TO THE COURSE : 28.09.2011



  1. TITLE OF THE TOPIC : Comparative study of lateral

Sphincterotomy and Nitroglycerin

ointment application in the treatment of

Chronic fissure in ano.

6. BRIEF RESUME OF THE INTENDED STUDY

6.1. Need for the study

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


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 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



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 them pharmacological 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 fissure in 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

healing rate.6

In 2007, Sanju Dhawan, Ph.D. and Sunny Chopra, said that chronic anal fissure

(CAF) is usually associated with internal anal sphincter spasm, the relief of which is central

to provide fissure healing. The treatment for CAF has undergone a transformation in recent

years from surgical to medical. Both the approaches share the common goal of reducing the

spasm. Though surgical treatment has a high success rate, it can permanently impair fecal

continence in a large number of patients. Smooth muscle relaxation seems to be a novel way

by which more than 60% of the patients can be cured with the topical use of the agents. This

treatment is in addition to the normalization of stools mostly. Smooth muscle relaxation is

well tolerated, can be administered on an outpatient basis, does not cause any lesion of the

continence organ, and subsequently, does not lead to any permanent latent or apparent fecal

incontinence. This review encompasses various agents that are used for smooth muscle

relaxation. In addition, it describes various clinical studies reported in the literature with their

success rates and side effects.7

In 2010 July, Aaron Poh, Kok-Yang Tan, Francis Sew- Cheon, said that

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



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

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.


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.


Exclusion Criteria

  1. Patients on nitrates for medical conditions like IHD.




  1. Fissures in pregnant women.




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




  1. Patients with immunocompromised state.

7.4. Does the study require any investigations/intervention to be conducted on

patients/humans/animals? If so, please describe briefly.

Yes, on the patients.



Investigations

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



  1. Urine – Albumin, Sugar, Microscopy



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



  1. ECG.



  1. 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,

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



M.S. (General Surgery)

Professor, Department of Surgery,

Mysore Medical College and Research Institute,

Mysore.


11.2 Signature of Guide :

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



M.S. (General Surgery)

Professor, Department of Surgery,

Mysore Medical College and Research Institute,

Mysore.


11.4 Signature of the HOD :

12. Remarks

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

And Nitroglycerin ointment application in the

Treatment of chronic anal fissure.

.

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



  1. SUBJECT : M.S. GENERAL SURGERY.

4. NAME OF THE GUIDE : Prof. Dr. Shivananda

M.S. (General Surgery)

Professor, Department of Surgery,

Mysore Medical College and Research Institute,

Mysore.


5. APPROVED/NOT APPROVED

(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



The DEAN AND DIRECTOR

Mysore Medical College and Research Institute, Mysore

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