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 |
| | |
| |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. |
| | |
| |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 |
| | |
| |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 |
| | |
| |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 |
| | |
| |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). |
| | |
| |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: |
| | |
| |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: |
| | |
| |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. |
| | |
| |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 |
| | |
| |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. |
| | |
| |7.4 Has the ethical clearance been obtained from your institution in the case of 7.3? |
| |Yes. |
|8. |List of references: |
| | |
| |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. |
| | |
| |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. |
| | |
| |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. |
| | |
| |Karppinen J, et al, Severity of Symptoms and Signs in Relation to Magnetic Resonance Imaging Findings Among Sciatica Patients, Spine |
| |2001; 26: 149-154. |
| | |
| |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. |
| | |
| |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. |
| | |
| |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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