Dr srijoy gupta



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SYNOPSIS

OF

DISSERTATION


Dr.SRIJOY GUPTA


DEPARTMENT OF ENT

J.J.M. MEDICAL COLLEGE, DAVANGERE

KARNATAKA,

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE KARNATAKA.




ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION


1

NAME AND ADDRESS OF THE CANDIDATE

Dr. SRIJOY GUPTA


POST GRADUATE IN ENT

DEPARTMENT OF ENT

J.J.M MEDICAL COLLEGE, DAVANGERE- 577004, KARNATAKA



2

NAME OF THE INSTITUTION

J.J.M. MEDICAL COLLEGE,

DAVANGERE – 577 004

KARNATAKA




3

COURSE OF STUDY AND SUBJECT

MS-OTORHINOLARYNGOLOGY

(ENT)

4

DATE OF ADMISSION


31.7.2013



5

TITLE OF THE TOPIC

A COMPARATIVE STUDY OF ENDOSCOPIC ENDONASAL DACRYOCYSTORHINOSTOMY WITH AND WITHOUT ADJUNCTIVE TOPICAL USE OF MITOMYCIN-C”



  1. BRIEF RESUME OF THE INTENDED WORK:




    1. Need for the study

Chronic Dacryocystitis is defined as the prolonged inflammation of the lacrimal sac,most commonly due to the obstruction of the nasolacrimal duct. External Dacryocystorhinostomy has been the surgery of choice for a very long time. With the advent of nasal endoscope, endo nasal endoscopic Dacryocystorhinostomy has come into existence and is becoming preferable over external Dacryocystorhinostomy.Although both procedures have comparable success rate, endoscopic Dacryocystorhinostomyis helpful in avoiding external scar on the face and injury to the neighbouring structures which are encountered in external Dacryocystorhinostomy and also has short duration of surgical procedure.

Various studies have shown the success rate of endoscopic Dacryocystorhinostomy at around 90% and is a safe alternative to the external procedure.

Studies conducted have also shown that intraoperative application of Mitomycin C, a wound healing inhibitor, a bifunctional or trifunctional alkylating agent, also an anticancer agent is effective in increasing success rates of Endoscopic Dacryocystorhinostomy.


This study is being carried out to determine the various indications and contraindications of Endoscopic Dacryocystorhinostomy and also to analyse Endoscopic DCR in terms of safety, cost, morbidity, hospital stay and cosmetic results. The success rate of endoscopic endonasal Dacryocystorhinostomy has been lower than external dacrocystorhinostomy, this study aims to analyse this point also and find out the reasons for this. It is to study the outcomes of this procedure. It is also for evaluating the efficacy of Mitomycin C in increasing the success rate of Endoscopic Endonasal Dacryocystorhinostomy.


    1. Review of literature

In another study done on 143 patients, it was found that endoscopic Dacryocystorhinostomy had advantages such as absence of skin incision, preservation of pump mechanism of the orbicularis oculi muscle less bleeding, limitation of injury to the tissue at the osteotomy site and faster rehabilitation[1]



Endoscopic DCR is practical, less traumatic, less time-consuming, and cosmetically more aesthetic than the external approach. The success rate of the endoscopic DCR procedure is comparable with that of traditional external DCR, and it also allows simultaneous correction of any intranasal pathology[2]
Between January 1990 and December 1993, 152 Endoscopic DCRs were performed in 133 patients in a study which showed that the intranasal approach is a safe alternative to the external approach, especially for a revision procedure. The results obtained are comparable to the external approach and cosmetic advantages are clear.[3]
A study which was conducted from April 1998 to June 1999 (involving 30 patients) highlighted the facts that there were no major complications and the time of hospital stay was very short when compared to the external approach. [4]
Every surgery undergoes some changes over time, a study conducted between January 2003 and February 2010 involving 265 patients analysed the role of Unciformectomy in endonasal DCR. It showed an increased success rate of surgery when Unciformectomy was combined with endonasal DCR.[5]
Application of Mitomycin C in endoscopic DCR was tested in a study conducted between January 2003and December 2004 which indicated that the intraoperative application of Mitomycin C did not alter long term outcome in Endoscopic DCR and an adequately performed surgery is more vital for a successful result. [6]
Another comparative study conducted on 40 patients to analyse the benefits of endoscopic DCR with and without Mitomycin-C showed a beneficial effect in preventing closure of rhinostomy stoma when Mitomycin was used and indicated it as the preferred treatment of choice in cases of chronic Dacryocystitis. [7]
A study conducted between January 1994 and April 1995 showed that External DCR appears to give a higher primary success rate, however surgical duration of endoscopic endonasal DCR was significantly shorter. [8]


    1. Objectives of the study




  1. To study the indications and contraindications of endoscopic endonasal Dacryocystorhinostomy

  2. To evaluate the procedure in terms of safety, cost, hospital stay and post operative morbidity

  3. To evaluate the results of endoscopic endonasal Dacryocystorhinostomy

  4. To evaluate the usefulness of topical application of Mitomycin-C in endoscopic endonasal Dacryocystorhinostomy


  1. MATERIAL AND METHODS





    1. Source of data



This is a randomised clinical trial on patients with chronic Dacryocystitis attending ENT and OPHTHALMOLOGY out-patient departments of Bapuji and Chigateri General Hospital, teaching hospitals attached to J.J.M.Medical College, Davangere.

Sample size- upto 50 cases

25 cases- with Mitomycin C

25 cases- without Mitomycin C




    1. Method of collection of data



  • All the patients coming to the ENT OPD and Ophthalmology OPD with history of excessive lacrimation (epiphora) are examined.Lacrimalpunctum and sac are examined and regurgitation of fluid through the punctum on pressing over the lacrimal sac is noted. Lacrimal syringing is routinely done in all the patients in Ophthalmology OPD to confirm the obstruction of the nasolacrimal duct.Patients will also be subjected to jone’s test, probing of canaliculi, thorough ENT examination to find out associated Nasal and Sinus pathology and Diagnostic nasal endoscopy will be done to confirm the same.

  • All routine investigations of Hb%, BT, CT, Urine Routine will be done after which patient will be posted for Endoscopic Endonasal Dacryocystorhinostomy.

  • At the end of the surgery topical Mitomycin C (0.2 mg/ml) will be applied for a period of 5 minutesto one set of patients and withheld in the other set of patients. The selection of patients will be random and they will be divided into two groups A and B, and the outcome shall be analysed in both sets.

  • Period of study from Nov 2013 to Nov 2015[1 ½ years]

  • Follow up period of upto 6 months following surgical procedure

  • Written well informed consent will be taken



Inclusion criteria




  • All the cases presenting with epiphora with established nasolacrimal duct obstruction.

  • Both male and female patients of varying age groups are to be included in the study.


Exclusion criteria


    • All cases with obstruction at level of punctum, canaliculi or common canaliculi

    • Pregnancy,lactating mother

    • < 15 years of age

    • lower eyelid laxity

    • previous lacrimal trauma

    • Suspicion of malignancy

    • Known case of acute or chronic renal failure, Known case of immunodeficiency.


Analysis of the study:

Categorical data will be analysed by chi-square test. All data will be analysed by proper methods. Age-wise and Gender-wise analysis of patients with symptoms of epiphora undergoing the procedure will be done. Patients will also be evaluated for laterality of symptoms and other ENT pathology. Analysis of lacrimal syringing findings and level and location of nasolacrimal duct obstruction shall also be carried out.

The surgery shall be assessed for both intraoperative and postoperative complications.

A randomized clinical trial will be conducted and Patients will be divided into groups A and B Post surgery each comprising of 25 cases. Mitomycin C shall be applied topically to one set and withheld in the other setand the results of both groups will be evaluated during follow-up and compared using Student unpaired t-test. Significance of the results of the tests will be according to the p-values. The outcome of the surgery will be evaluated based on the relief of symptoms, patency of the nasolacrimal ducts post-surgery and complications arising if any during the follow-up period.




    1. Does the study require any investigations or interventions to be conducted on patients or other humans or animals?

YES



  1. Syringing of the lacrimal drainage system

  2. Jone’s test, probing of lacrimal canaliculi

  3. Dacryocystogram

  4. Diagnostic nasal endoscopy

  5. X-RAY of paranasal sinuses.

  6. Routine investigations like complete haemogram,bleeding time, clotting time, blood grouping, random blood sugar and urine examination

  7. HIV, HbsAg




    1. Has ethical clearance been obtained from your institution in case of 7.3?

YES



  1. List of References




  1. Durvasula V, Gatland DJ. Endoscopic Dacryocystorhinostomy:long-term results and evolution of surgical technique. Journal ofLaryngol Otol 2004;118:628 –32.




  1. Yasar Cokkeser,Cem Evereklioglu,Hamdi Er et al.Comparative External Versus Endoscopic Dacryocystorhinostomy:Results in 115 Patients (130 Eyes).Otolaryngology and Head and Neck Surgery.October 2000,123:488-491




  1. Manuel Bernal Sprekelsen, MD; Manuel Tomas Barberan, MD. Endoscopic Dacryocystorhinostomy: Surgical technique and Results. Laryngoscope, 106:187-189,1996




  1. V.P. Venkatachalam, Sanjay Agarwal. Endoscopic Dacryocystorhinostomy. Indian Journal of Otolaryngology and Head and Neck Surgery Vol.52 No.4, October –December 2000




  1. Jae Wook Yang 1, 2 and Ha Na Oh 1, 2. Success rate and complications of Endonasal Dacryocystorhinostomy with Unciformectomy. Graefes Arch Clin Exp Ophthalmol.2012 October; 250(10): 1509-1513.

  2. Soumitra Ghosh, Amitabha Roychoudhury, B.K.Roychaudhuri. Use of Mitomycin C in Endo-DCR. Indian Journal of Otolaryngology and Head and Neck Surgery Vol.58 No.4, October –December 2006




  1. A.S.Harugop, B.K.Rekha, R.S.Mudhol, N.D.Zingade, S.M.Hugar, A.T.Das and M.Maheshwaran. A Randomized placebo controlled trial of Mitomycin-C in surgical outcome of primary endoscopic Dacryocystorhinostomy. Al Ameen J Med Sci 2013; 6(3):231-236.




  1. Jouko Hartikainen, MD; Jukka Antila, MD; Matti Varpula, MD; Pauli Puukka, MSc; Heikki Seppa, MD, PhD; Reidar Grenman, MD, PhD. Prospective Randomized Comparison of Endonasal Endoscopic Dacryocystorhinostomy and External Dacryocystorhinostomy.Laryngoscope,108:1861-1866,December-1998.

9.

Signature of Candidate





10.

Remarks of the guide


This study helps in evaluating the reasons for failure in failed Endoscopic Endonasal Dacryocystorhinostomy. It will also help to improve the success rate of Endoscopic Endonasal Dacryocystorhinostomy.

11.

Name and Designation of

(in Block Letters)









11.1 Guide


Dr. PRAKASH N.S


READER

DEPARTMENT OF ENT

J.J.M MEDICAL COLLEGE, DAVANGERE, KARNATAKA





11.2 Signature






11.3 Co-guide(if any)









11.4 Signature








11.5 Head of Department


Dr. K.V. LOKANATH


PROFESSOR AND HEAD

DEPARTMENT OF ENT



J.J.M MEDICAL COLLEGE, DAVANGERE, KARNATAKA




11.6 Signature





12.

12.1 Remarks of the Principal








12.2Signature










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