Rajiv Gandhi University of Health Sciences s120

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA 4TH ‘T’ BLOCK, JAYANAGAR, BANGALORE-560041

PROFORMA FOR REGISTRATION OF SUBJECT OF DISSERTATION

TOPIC “A STUDY ON THE ROLE OF TOPICAL MITOMYCIN-C

APPLICATION IN PREVENTION OF NASAL SYNECHIAE AFTER

FUNCTIONAL ENDOSCOPIC SINUS SURGERY- A COMAPARATIVE

STUDY”

Dr. SHIRISH. R. PATIL POSTGRADUATE DEPARTMENT OF OTORHINOLARYNGOLOGY SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF MEDICAL SCIENCES & HOSPITAL MANJUSHREE NAGAR, SATTUR, DHARWAD-580009 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 Name of the candidate and DR. SHIRISH. R. PATIL address POSTGRADUATE

DEPARTMENT OF OTORHINOLARYNGOLOGY

SRI DHARMASTHALAMANJUNATHESHWARA

COLLEGE OF MEDICAL SCIENCES & HOSPITAL

MANJUSHREE NAGAR,

SATTUR, DHARWAD-580009 2 Name of the institution SRI DHARMASTHALAMANJUNATHESHWARA

COLLEGE OF MEDICAL SCIENCES & HOSPITAL

MANJUSHREE NAGAR,

SATTUR, DHARWAD-580009

KARNATAKA 3 Subject M.S., OTORHINOLARYNGOLOGY

4 Date of admission to course 10/06/2013

5 Title of the topic “A STUDY ON THE ROLE OF TOPICAL MITOMYCIN-C APPLICATION IN PREVENTION OF NASAL SYNECHIAE AFTER FUNCTIONAL ENDOSCOPIC SINUS SURGERY – A COMPARATIVE STUDY” 6 Brief resume of the intended work 6.1.Need for the study Rhinosinusitis is widely believed to comprise a spectrum of inflammatory and infectious diseases concurrently affecting the nose and paranasal sinuses. Functional endoscopic sinus surgery (FESS) was originally designed to address obstruction in the ostiomeatal complex as described by Messerklinger, has been fully accepted for treating chronic sinus disease. It aims to restore paranasal sinus ventilation and re-establish mucociliary clearance, which in turn leads to the resolution of sinus disease and maintenance of healthy sinus mucosa. Endoscopic approaches are much more acceptable to patients because of less pain, shorter recoveries and no or minimal external scarring1. Treatment of choice for chronicrhinosinusitis is Functional Endoscopic Sinus Surgery (FESS), one of the most frequently performed procedures in the ENT practice. Despite its efficacy and safety, 7.6% to 38% of the patients experience relapsing symptoms and undergo revision surgery. The causes of treatment failure include disturbed mucociliary clearance, immunodeficiency, sensitivity to acetylsalicylic acid and anatomic obstruction. The most frequent events related to the latter cause are synechiaeand ostium stenosis (27% in maxillary sinuses and 25% in frontal sinuses)2. Obstruction at the ostio-meatal complex due to synechiae, the commonest anatomical finding in revision endoscopic sinus surgeryfound in 11% and 36% of the cases.Synechiae formation is presumed to result from the proximity of two or more raw mucosal surfaces to each other during wound healing . Although not all synechiae formation requires therapy, total ostial stenosis and obstruction of critical outflow tracts may result in surgical failure and hence the need for revision therapy3. Mitomycin-C (MMC) is an antibiotic-antineoplastic agent first isolated from Streptomyces caespitosusin in 1958. It inhibits the synthesis of Deoxyribose Nucleic Acid (DNA) through a bifunctional alkylation that leads to the crossing of double helical strands and inhibits proliferation of fibroblasts and hence scarring when used topically. The antiproliferative effect MMC has on human fibroblasts is the reason why it can modulate scarring and prevent excessive fibrosis formation. It has antiproliferative properties at 0.04mg/ml and higher concentrations. One single topical application of MMC for five minutes offers antiproliferative effects for up to 36 hours4.

MMC has been used more recently in ENT procedures such as laryngotracheal stenosis repairs, to maintain patency in myringotomy, and its use in sinus surgery has been successfully studied.

Since FESS is a very common surgical procedure done these days, thepurpose of this study is to assess the effectiveness of MMC in humans to prevent synechiaeformation after FESS by its application to the sinonasalmucosa at the conclusion of surgeryand hence to reduce the need for revision FESS. 6.2 Review of literature Ingrams et al., in a trial with rabbits, looked into patency, antrostomy areas, and ciliary function of the mucosa treated with MMC dosages of 0.04 mg/mL, 0.4 mg/mL and 1 mg/mL. The authors verified that 0.4 mg/mL and 1 mg/mL of MMC maintained patency and antrostomy areas with a statistically significant difference against controls. Additionally, ciliary appearance and function returned to normal within two weeks and the mucosal surface re-epithelialized normally. Rahal et al., using 1 mg/mL of MMC in rabbits, concluded that MMC maintained antrostomy patency in areas significantly greater than saline solution without complications. However, studies in human beings with 0.4 mg/mL and 0.5 mg/mL of MMC failed to replicate the outcomes seen in experimental trials5.

In a randomized controlled trial done by Chung JH et al., to determine the effectiveness of application of MMC at the conclusion of sinus surgery to decrease the incidence of postoperative adhesion formation, it was noted that post-operative adhesions were observed in 26% of patients, with a mean follow-up of 4.1 months. These adhesions were found to be bilateral in 10.9% and unilateral in 18% of the patients. Unilateral adhesions were observed in only two cases (3.6%) treated with MMC as compared to eight in the control group. Hence the study concluded that MMC could be used safely during sinus surgery, and it may reduce the incidence of postoperative adhesions at the dosage used in this study.

Venkatraman et al., conducted a randomized controlled trial involving 50 patients with chronic bilateral rhino sinusitis. They eliminated various confounding factors by studying a single group of patients, with symmetrical disease, without pre-existing gross anatomical abnormalities. Patients requiring revision sinus surgery were excluded. On completion of the surgery, a cotton pledget soaked in Mitomycin C was placed in one nostril (test) and saline-soaked pledget (control) was placed in the other side of the nose, both in the middle meatus. The side of the nasal cavity receiving the topical Mitomycin C was randomized. The patients were assessed periodically (first week, first month, third month and sixth month) for synechiae formation and presence or absence of their symptoms. At the first week follow up, there was a statistically significant difference in the incidence of synechiae between the saline and Mitomycin C side. Furthermore, there was a statistically significant improvement with regards to patient symptoms (nasal block and discharge) in the Mitomycin C side when compared to the saline side. At the third and sixth month, there was no difference between the two groups. They concluded that incidence of adverse tissue reaction (granulation, discharge, polypoidal mucosa and crusting) was less in the Mitomycin C side when compared to the saline side at the first month follow up. Topically applied Mitomycin C reduces the incidence of synechiae in the immediate post-operative period in patients undergoing endoscopic sinus surgery. There is also an improvement in nasal obstruction and discharge with a reduction in the incidence of adverse tissue reaction in the early post-operative period.

In a prospective , randomized controlled trial, Gupta M and Motwani Gstudied the role of mitomycin c reducing adhesion formation following endoscopic sinus surgery.Thirty patients were selected suffering long-term problems with bilateral chronic rhinosinusitis, with no relief obtained from medical therapy. Patients requiring revision sinus surgery or having acute upper respiratory tract infection were excluded.Diagnostic nasal endoscopies and non-contrast computerized tomography of nose and paranasal sinuses were undertaken and, following confirmation of the diagnosis, functional endoscopic sinus surgery (FESS) was carried out bilaterally using the Messerklinger technique. On completion of the surgery, a cotton wick soaked in mitomycin C was placed in one or other side of the nose in the middle meatus. Follow up was for three months and patients were assessed for subjective and objective improvement in their symptoms.Post-operatively, of the 11 (36.6 per cent) patients complaining of persistent nasal obstruction, nine had complaints limited to the control side only (p=0.005). Out of the nine (30 per cent) patients complaining of recurrent nasal discharge, eight had complaints on the control side and only one reported discharge from both sides (p=0.006). They concluded that Mitomycin C may be topically applied in postoperative FESS cases to reduce adhesion formation and hence the need for revision surgery. Wellington Yugo Yamaoka andLuís Carlos Gregório conducted a prospective study aimed to assess the effectiveness of topical MMC in the prevention of synechia after sinus surgery in humans. At the end of endoscopic sinus surgery, MMC solution (1.0 mg/ml) was topically applied randomly to one of the middle meatuses (MMC group) of 14 patients while saline solution was applied to the contralateral meatus (control group). The author remained blind to the medicated side. Synechiae were classified as partial or total. Results were as follows;three patients had middle meatus synechia in the MMC group (21.43%) versus nine (64.29%) in the control group (p = 0.054). In the MMC group, all three middle meatus synechia were partial, while in the control group there were four partial (28.57%) and five total (35.71%) cases of synechia (p = 0.025). They concluded thatMitomycin C was not effective in preventing middle meatus synechia, but reduced the probability of total synechia formation.

Mohammad- HosseinBaradaranfar et al., performed a study to investigate the effect of Mitomycin C in reducing scar formation and adhesion in the nasal mucosa after endoscopic nasal surgery. This double blind randomized clinical trial study was performed on 37 patients with bilateral chronic rhinosinusitis. At the end of FESS, randomly impregnated mesh with MMC was placed in one side and another mesh impregnated with saline in the opposite side for 5 minutes. Patients were followed at least for three months, and the results of diagnostic endoscopy were recorded. Post operative adhesion occurred in 12 (32.4%) patients (2 bilateral/10 unilateral). Among total of 14 adhesions, 4 (10.8%) were in the MMC side and 10 (27%) in the control side. This differences was close to statistically significant (P=0.058). MMC may reduce adhesions after FESS, but further studies with different doses, sample size and frequent use of topical MMC is recommended.

In a prospective study conducted byTilakraj Singhet al.,to evaluate the role of Mitomycin-C in preventing synaechiae formation and ostial stenosis following endoscopic sinus surgery, conducted in VMMC and Safdarjung hospital from November 2007 to August 2008, 30 subjects aged between 16 and 60 of either sex in two groups were included. All these patients with bilateral nasal polyposis underwent endoscopic sinus surgery with topical application of Mitomycin-C and were subjectively and objectively assessed for improvement of symptoms and post operativesynaechiae formation. Patients showed improvement in subjective symptoms mainly nasal obstruction and hyposmia as well as decreased incidence of synaechiae formation and ostial stenosis post surgery following Mitomycin-C application. After doing this study they could conclude that Mitomycin–C applied topically following endoscopic sinus surgery was helpful in improvement of symptoms like nasal obstruction and hyposmia as well as decreased adhesion rate and middle meatalantrostomy closure rate. Topical application of Mitomycin-C was safe in a dose of 0.4–0.8 mg/ml applied over 5 min and offered significant improvement both subjectively and objectively. 6.3 Objective of the study 1. to assess the effectiveness of topical Mitomycin -C in the prevention of synechia after sinus surgery

7 Materials and methods 7.1 SOURCE OF DATA:  Study subjects: The study population consists of 50 patients of chronic rhino-sinusitis attending Out Patient Department (OPD) in Otorhinolaryngology Department of Sri Dharmastala Manjunatheshwara Medical College and Hospital, Dharwad

Inclusion Criteria: 1) All cases of bilateral chronic rhinosinusitis undergoing FESS within the age group of 18-60 years 2) All cases of bilateral chronic rhinosinusitis undergoing FESS with DNS requiring additional septoplasty. 3) All cases of bilateral chronic rhinosinusitis undergoing FESS with nasal polyposis.

Exclusion Criteria: 1) Cases requiring revision functional endoscopic sinus surgery. 2) cases of fungal sinusitis 3) cases of sinonasal tumours 4) cases of unilateral rhinosinusitis requiring unilateral FESS 5) cases with history of previous nasal surgery

 Study area: Department of Otorhinolaryngology, Sri Dharmastala Manjunatheshwara Medical College and Hospital, Dharwad

 Study period: One and a half year. From November 2013 to June 2015

7.2 METHODS OF COLLECTION OF DATA:

 Study design: Comparative Prospective study  Sample size: The study sample will consist of 50 cases of chronic rhino-sinusitis attending OPD of Department of ENT. At the conclusion of FESS, on one side of the nose, a cotton pledget soaked in saline and on the other side a cotton pledget soaked in MMC will be placed. The study participants will themselves act as their control.

 Data collection: During the study period, cases of chronic rhino-sinusitis, willing to give a written informed consent, will be enrolled in the trial. The cases will be interviewed to obtain basic socio-demographic data and presenting clinical history. Clinical evaluation will be done and the laboratory investigations will be noted. Each patient will undergo diagnostic nasal endoscopic examination and CT para nasal sinuses (3mm-5mm cuts), and the findings will be recorded.

 Surgical procedure : Informed consent will be taken from all the patients for the planned procedure in proforma approved by our institutional ethical committee. They will also be informed about the topical use of Mitomycin-C. The concentration of Mitomycin C will be 0.8 mg/ml . One vial contains 2 mg of MMC which is diluted with 2.5 ml sterile water to obtain the above concentration. After induction of general anaesthesia / local anaesthesia, the nasal cavities were filled with a cotton swab soaked in 4% lignocaine with 1/100,000 UI epinephrine. Septal deviations hampering the access to ostiomeatal complexes were corrected at the start of the procedure. The extent and location of the disease determine which cavities would be approached. Under local/ general anaesthesia, endoscopic surgery was done using Karl Storz endoscopes. The Messerklinger approach was used to treat the involved paranasal sinuses. Antrostomy procedures were done in the posteroanterior orientation in a non-circular fashion with a diameter always greater than 3 mm as defined by Stammberger. At the end of the procedure a small sterile cotton ball with 1 mL of MMC (0.8 mg/ml) was placed on one of the middle meatuses for 5 minutes. Another small sterile cotton ball soaked in 1 mL of saline solution was placed in the contralateral control middle meatus for 5 minutes. The cotton swabs were then removed and both the middle meatus were packed with ribbon gauze packs until 48hours.

Postoperative treatment and follow-ups Nasal pack will be removed two days after surgery. Patient will be discharged on the second postoperative day.Each patient will be given an antibiotic, analgesic and antihistaminic medication for one week. Patients will also be advised to irrigate the nasal cavity with Normal saline 0.9%, 10 drops on each side thrice daily to remove crusts, followed by instillation of xylometazoline nasal drops 0.1%, 3 drops thrice daily for one week.Patients will be appointed for follow-up one week after discharge, one month and three months after surgery for post operative nasal endoscopy. In each case, the nasal cavities were examined with an endoscope after the application of 4% lignocaine with epinephrine of 1/1,00,000. Both sides of the nasal cavity were examined for synechiae. Synechiae are characterized as adhesion between two mucosal surfaces and were categorized as partial when the middle meatus was not completely obstructed and complete when middle meatus was completely obstructed. Meatuses were deemed open only when no synechiae was found.

 Study analysis: Descriptive statistics will be applied. Data will be analysed by proportions and percentages. Further Chi-square test will be applied to find out association between two attributes. Statistical significance will be set at 0.05% level of significance (p < 0.05)

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly. YES. Routine blood and radiological investigations required for the preoperative evaluation of the patient for surgery will be done.

7.4 Has the ethical clearance been obtained from your institute? YES 8. List of References

1.Tilakraj Singh, Himani Lade, and V. Natesh. Role of Mitomycin-C in Prevention of Post Operative Adhesions After Endoscopic Sinus Surgery––A Prospective Study. Indian J Otolaryngol Head Neck Surg. 2011 July; 63(3): 249–254.

2. Wellington Yugo Yamaoka, Luís Carlos Gregório.The use of Mitomycin-C to reduce synechia in middle meatus in sinus surgery: preliminary results. Braz J Otorhinolaryngol. 2012;78(5):44-50.

3. Tabaee A, Brown, Seth M, Anand, Vijay K. Mitomycin C and endoscopic sinus surgery: where are we? CurrOpinOtolaryngol Head Neck Surg. 2007 Feb;15(1):40-3.

4. Martin Dale. The complete drug reference. Pharmaceutical press, 2009, 36th edition

5.Chung JH, Cosenza MJ, Rahbar R, Metson RB. Mitomycin C for the prevention of adhesion formation after endoscopic sinus surgery: a randomized, controlled study.Otolaryngol Head Neck Surg. 2002 May;126(5):468-74. 9 SIGNATURE OF THE CANDIDATE:

10 REMARKS OF THE GUIDE: This study will help to prevent synechiae formation & will also help to improve surgical outcome.

11 11.1 NAME AND DESIGNATION OF Dr. ARUNKUMAR. J. S THE GUIDE: Professor Department of Otorhinolarygology SDM College of Medical Sciences & Hospital Manjushree Nagar, Sattur, Dharwad-580009

11.2 SIGNATURE OF THE GUIDE:

11.3 HEAD OF THE DEPARTMENT: Dr. ASHOK. S. NAIK Professor& HOD Department of Otorhinolaryngology SDM College of Medical Sciences & Hospital Manjushree Nagar, Sattur, Dharwad-580009

11.4 SIGNATURE OF THE HEAD OF THE DEPARTMENT:

12 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL:

12.2 SIGNATURE OF THE PRINCIPAL: SDM COLLEGE OF MEDICAL SCIENCES & HOSPITAL SATTUR, DHARWAD 580009

INFORMED CONSENT FORM

I ______declare that I have been briefed and hereby given consent to be included as a subject in the following dissertation “A STUDY ON THE ROLE OF TOPICALMITOMYCIN-C APPLICATION IN PREVENTION OF NASAL SYNECHIAE AFTER FUNCTIONAL ENDSCOPIC SINUS SURGERY– A COMPARATIVE STUDY”.

I have been informed to my satisfaction by the attending doctor, Dr. SHIRISH. R. PATIL, the purpose of the study, required procedure and treatment option. The doctor has also explained to me about the possible complications of FESS, viz., recurrence, intraorbital complications, intracranial complications and possible complications of anaesthesia viz., cardiorespiratory arrest. This has been explained to me in the language I understand and I fully give my consent for the same.

I hereby give full consent to use the data obtained and the photographs taken during the study for the purpose of publication in professional journals.

Signature of the doctor Signature of patient/relative Name of the doctor: Name Relationship Date: Dharwad.

PROFORMA “A STUDY ON THE ROLE OF TOPICAL MITOMYCIN-C APPLICATION IN PREVENTION OF NASAL SYNECHIAE AFTER FUNCTIONAL ENDOSCOPIC SINUS SURGERY- A COMPARATIVE STUDY”

Name: Age: Sex: Occupation: Address: OP/IP NO:

Chief complaints

History of present illness

General physical examination

Systemic examination

ENT examination

Diagnosis:

Proposed operation:

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