Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE - II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. |Name of candidate and address: |Dr. ANOOP RAMAKRISHNA HEGGUNDA |

| | |# 95K, 13TH CROSS, K.M. HALLI, RAJAJINAGAR 1ST BLOCK, |

| | |BANGALORE - 10. |

|2. |Name of institution: |BANGALORE MEDICAL COLLEGE |

| | |AND RESEARCH INSTITUTE, BANGALORE-02. |

|3. |Course of study and subject: |POST GRADUATE |

| | |M .S. ORTHOPAEDICS |

|4. |Date of admission to the course: |1ST JUNE 2011 |

|5. |Title of the topic: |“PROSPECTIVE STUDY OF OPEN LUMBAR DISCECTOMY IN DIFFERENT STAGES OF |

| | |DISC PROLAPSE.” |

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|6. |Brief resume of intended work: |

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| |6.1 Need for study: |

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| |By any measure, disc disorders are a tremendous problem. In all studies of lumbar spine disorders 10% of patients account for more |

| |than 80% of the total healthcare & social costs. The 1% of patients who undergo surgery is most expensive group. Although surgical |

| |investigations & interventions account for up to 1/3 of the health care costs the scientific evidence for most procedures is unclear.1|

| |In recent years understanding of disc degeneration has undergone a significant transformation; however the treatment of disc |

| |degeneration with or without herniation and the associated pain is far from satisfactory.2 |

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| |The surgical treatment of prolapsed lumbar intervertebral disc has evolved since the initial report of lumbar discectomy by Mixter and|

| |Barr in 1934. It is a common cause for back & leg pain – sciatica. The term disc prolapse is a broad term which includes 4 stages - |

| |Disc bulge, Protrusion (sub ligamentous herniation), Extrusion (trans ligamentous herniation) & Sequestration (free fragment). |

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| |Surgical practice should have a proper scientific basis. Results of open lumbar discectomy are done taking into consideration all the |

| |stages of disc lesion together; however results vary in different stages. Hence it is necessary to define the optimal management for |

| |specific types of prolapse. |

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| |6.2 Review of literature: |

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| |In a retrospective study by Boden S D, Davis DO, Dina TS, et al of more than 900 patients who underwent lumbar discectomy with a mean |

| |follow up of 10 years, good results were noted in 89%with a 4% complication rate.3 In a classic study by Toyone T et al showed that |

| |lumbar disc herniation is a common cause of low back pain & surgical treatment of lumbar disc herniation is a well established |

| |procedure & high rates of success have been achieved in patients with failure of conservative treatment or those with acute & |

| |progressive neurological deficits.4 |

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| |From the work of Karppinen J et al the size & severity of disc herniation do not correlate with the degree of patient, disability or |

| |suffering i.e. even disc bulge may cause just as much pain & disability as massive disc herniation & even extrusion.5 In a study by, |

| |Ng LC, Sell P, predictive value of the duration of sciatica for lumbar discectomy. A prospective cohort study showed that patients |

| |with disc extrusion had a shorter duration of symptoms & better functional outcome than those with disc protrusion.6 |

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| |Numerous retrospective & some prospective reviews of open disc surgery are available. Good results range from 46% to 97%. |

| |Complications range from none to more than 10%. Reoperation rate 4% to 20%.The extremely detailed work of Weir suggests that the |

| |duration of current episode, age of patient, presence or absence of predominant back pain, the number of previous hospitalizations & |

| |presence or absence of compensation for a work injury are factors affecting final outcome. Spangfort’s work also indicates that the |

| |softer the findings for disc herniation clinically & at the time of surgery, the lower the chance of good results.2 |

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| |Studies by Atlas SJ et al, Peul WC et al have demonstrated higher recovery rates & more complete relief of leg pain, higher |

| |improvement of satisfaction with treatment & perceived recovery following disc surgery compared with patients treated non |

| |surgically.7,8 From the studies of Ng LC, Sell P & Dewing CB et al on surgically treated patients; shorter duration of sciatica & |

| |significantly better functional outcome were seen in patients with contained herniation compared to uncontained (sequestrated or |

| |extruded) herniation.6,9 In a retrospective study by KN Acharya, TS Senthil Nathan, J Renjit kumar, K Venugopal menon of case records |

| |of 273 patients who underwent lumbar discectomy concluded that lumbar discectomy is a safe, simple & effective procedure with |

| |satisfactory outcome in 96.5% of primary disc surgery & 78.6% of revision disc surgery.10 |

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| |6.3 Aims and objectives of study: |

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| |To study the demographic profile of patients suffering from disc lesion. |

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| |To compare the results in different stages & define optimal management for specific types of prolapse. |

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|7. |Materials and methods |

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| |7.1 Source of data: |

| |Adult patients of either sex having disc lesion who are admitted in Victoria hospital and Bowring & Lady Curzon hospitals attached to |

| |Bangalore Medical College and Research Institute. |

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| |7.2 Method of collection of data: |

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| |A. Study design: Prospective study. |

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| |B. Study period: November 2011 to May 2013. |

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| |C. Place of study: Victoria hospital and Bowring & Lady Curzon hospitals. |

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| |D. Sample size: It is a hospital based study of 40 cases who are fulfilling the inclusion/exclusion criteria. |

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| |E. Inclusion Criteria: |

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| |Patients giving written informed consent(Annexure-1). |

| |Patients with radicular pain. |

| |Patients with evidence of nerve root irritation by positive Straight Leg Raising Test (SLRT). |

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| |Patients with corresponding neurological deficits. |

| |Patients aged more than 18 years will be included in the study. |

| |Patients with disc prolapse confirmed by MRI scan. |

| |Patients with multiple herniations are included if only one of the herniation is considered symptomatic. |

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| |F. Exclusion Criteria: |

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| |Patients with prior lumbar surgery. |

| |Patients with Cauda equine syndrome, vertebral fractures, inflammatory spondyloarthropathy. |

| |Patients with spinal deformities, polio and cerebral palsy. |

| |Patients with systemic infection, comorbid conditions. |

| |Pregnancy and lactating mother. |

| |G. Methodology: |

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| |Patients of Victoria hospital and Bowring & Lady Curzon hospitals with Disc lesion fulfilling the inclusion & exclusion criteria will|

| |be taken in to study after obtaining written informed consent. Demographic data, History, Clinical examination and details of |

| |investigations and intervention in the form of open lumbar discectomy will be recorded in the study proforma. Clinical follow up at |

| |2wks, 3months, 6 months &1year intervals regarding pain, disability and the functional outcome will be evaluated. |

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| |Assessment tools are |

| |Visual analogue scale (VAS) pain rating |

| |Modified Oswestry Disability Index (ODI) |

| |Short Form Health Questionnaire (SF 36) |

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| |The detailed schedule of patient visit is as follows: |

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| |Visit 1/day 1/initial or baseline assessment |

| |Patients will be informed fully about the purpose and requirements of the study and written informed consent will be |

| |taken.(Annexure-1) |

| |Patients will be enrolled as per protocol criteria. |

| |Details of patient’s demographic data, History, complete clinical and neurological examinations will be recorded. |

| |Pain and disability will be assessed using assessment tools. |

| |Details of investigations and open lumbar discectomy will be recorded. |

| |Pain and disability will be assessed postoperatively. |

| |Medications will be issued to the patients and instructed for regular follow up at 2 weeks, 3months, 6 months and 1 year. |

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| |Next visits(2 weeks,3months, 6months, 1year): |

| |Neurological status will be assessed. |

| |Pain, disability and functional outcome will be assessed using assessment tools. |

| |Medication compliance, any intercurrent illness or change in concomitant medication will be noted. |

| |During this time any investigation needed will be done. |

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| |H. Statistical analysis: |

| |The data in this study will be assessed using ANNOVA test. |

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| |7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals specify? If so, |

| |please describe briefly |

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| |It does not require any animal studies. |

| |This study requires |

| |Routine hematological investigations |

| |Urine routine |

| |ECG |

| |Xray of spine |

| |MRI of spine |

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| |The surgery is standard Open Lumbar Discectomy under general anaesthesia. |

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| |7.4 Has the ethical clearance been obtained from your institution in the case of 7.3? |

| |Yes. |

|8. |List of references: |

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| |Gibson JNA, Grant IC, Waddell G. The Cochrane Review of Surgery for Lumbar Disc Prolapse and Degenerative Lumbar Spondylosis. |

| |Lippincott Williams & Wilkins Inc., Spine Volume 24(17): 1820–1832. |

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| |Williams K.D, Park A.L. Lower back pain & disorders of Intervertebral discs. Canale ST, Beaty JH. Campbell’s operative orthopaedics. |

| |Elsevier Inc.. 11th edn. Vol 2. 2008; Ch39: 2159-2236. |

| |Hardy RW , Ball PA. Treatment of disc disease of the Lumbar spine. |

| |Winn HR. Youman’s Neurological surgery. Elsevier Inc.. 5th edn. Vol 4. 2004; Ch293: 4507-39. |

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| |Toyone T, Tanaka T, Kato D, Kaneyama R: Low-back pain following surgery for lumbar disc herniation. J Bone Joint Surg, 2004; 86-A: |

| |893–896. |

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| |Karppinen J, et al, Severity of Symptoms and Signs in Relation to Magnetic Resonance Imaging Findings Among Sciatica Patients, Spine |

| |2001; 26: 149-154. |

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| |Ng LC, Sell P, Predictive value of the duration of sciatica for lumbar discectomy. J Bone Joint Surg Br. 2004 May; 86(4): 546-9. |

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| |Atlas, S.J., et al. Long-term outcomes of surgical and nonsurgical management of |

| |sciatica secondary to a lumbar disc herniation: 10 year results from the Maine |

| |lumbar spine study. Spine (Phila Pa 1976), 2005; 30(8): 927-35. |

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| |Peul, W.C., et al., Surgery versus prolonged conservative treatment for sciatica. N Engl J Med, 2007; 356(22): 2245-56. |

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| |Dewing, C.B., et al., The outcomes of lumbar microdiscectomy in a young, active population: correlation by herniation type and level. |

| |Spine (Phila Pa 1976), 2008; 33(1): 33-8. |

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| |Acharya KN, Nathan TSS, Kumar JR,Menon KV, Primary and revision lumbar discectomy: A three-year review from one center. Indian J |

| |Orthop. 2008 Apr-Jun; 42(2): 178–181. |

|9. |Signature of candidate: | |

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| | |(Dr. ANOOP RAMAKRISHNA HEGGUNDA) |

|10. |Remarks of the guide: |Open lumbar discectomy has been the standard for management of disc |

| | |lesion, however because of our new understanding in different stages |

| | |of disc lesion, result of treatment will also vary. Present study will|

| | |compare the outcome in different stages of disc lesion. |

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|11. |11.1 Name and designation of Guide: |Dr. MANOJ KUMAR H.V |

| | |MBBS, MS (Ortho) |

| | |Professor, |

| | |Department of Orthopaedics, |

| | |Bangalore Medical College and Research Institute, |

| | |Bangalore. 560002 |

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| |11.2 Signature: | |

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| | |Dr. MANJUNATH K.S. |

| |11.3 Co-guide if any: | |

| | |MBBS, D Ortho, DNB (Ortho) |

| | |Professor and Head Of the Department, |

| | |Department of Orthopaedics, |

| |11.4 Signature: |Bangalore Medical College and |

| | |Research Institute, |

| | |Bangalore. 560002 |

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| |11.5 Head of the department: | |

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| |11.6 Signature: | |

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|12. |12.1 Dean and Director: |Prof Dr. O.S. SIDDAPPA |

| | |MBBS, M.S, Mch |

| | |Dean and Director, |

| | |Bangalore Medical College and Research Institute, |

| | |Bangalore. 560002 |

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| |12.2 Remarks: | |

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| |12.3 Signature: | |

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| |ANNEXURE 1 |

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| |I, Mr/Mrs/Ms________________________ , exercising my own free will power of choice, hereby give consent for myself as an object in |

| |the PROSPECTIVE STUDY OF OPEN LUMBAR DISECTOMY IN DIFFERENT STAGES OF DISC PROLAPSE conducted by Prof Dr. Manojkumar H.V., Dr. Anoop |

| |Ramakrishna Heggunda, Department of Orthopaedics, Bangalore Medical College and Research Institute, Bangalore. |

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| |The attending doctors have informed me to my satisfaction and in the language best understood by me, the purpose of this study, the |

| |materials to be used during the course of this study as well as the side effects / complications associated with the methods/tools to|

| |be used. |

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| |I shall not hold the doctors or the staff responsible for any untoward consequences. |

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| |I am also aware of my right to opt out of the study without prejudice to further treatment at any time during the course of the study|

| |without having to give any reasons to do so. |

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| |Signature of the attending doctor: Signature/Left thumb |

| |impression of the patient |

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| |DATE: |

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