RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE 2 PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE AND DR. MANAS BABU . B ADDRESS. PG IN GENERAL SURGERY KIMS, HUBLI – 580022

2. NAME OF THE INSTITUTION. KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI-22

3. COURSE OF STUDY AND SUBJECT M.S. GENERAL SURGERY

4. DATE OF ADMISSION 05-06-2010

5. TITLE OF THE TOPIC “A STUDY OF VENOUS LEG ULCERS”

1 6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY  Venous ulcers , also known as Ulcus crurus, venous insufficiency ulcers or venous leg ulcers or gravitational ulcers, are severe clinical manifestations of chronic venous insufficiency.  A chronic venous ulcer can be defined as an area of discontinuity of epidermis, persisting for four weeks or more and occurring as a result of venous hypertension and calf muscle pump insufficiency. Venous ulcers are located at the severe end of the spectrum of chronic venous disorders of the leg, because of this they occur more often in subjects with other forms of venous diseases such as varicose veins and skin changes.  They are thought to be the most common chronic wound among the ambulatory elderly, afflicting an estimated 0.2–1% of the total population and 1–3% of those over 60 years of age at any given time , accounting for 60–70% of chronic ulcers of the lower limb , with prevalence rising in western countries as the population ages .  Venous ulcer occurs on average about 13 years after the onset of chronic venous insufficiency and recurs after healing in 54–78% of patients.  Studies on patients with venous ulcers in the UK have shown high levels of depression, pain and isolation, with very considerable gains from effective treatment.  The management of leg ulcers comprises a significant portion of the workload of community and hospital nurses, general practitioners, dermatologists, surgeons and physicians involved in the care of the elderly.  So the study is undertaken to study the etiology ,incidence, mode of clinical presentation, and management of Venous leg ulcers.

6.2 REVIEW OF LITERATURE.  A study in Brazil reported Venous ulcer to be more prevalent in individuals with

2 less economic resources and fewer years of education . Annual costs of venous ulcer management have been estimated at £200 million in the United Kingdom, US$ 1 billion the United States and $AU 550–650 million in Australia , with each Venous Ulcer costing an estimated US$ 27 500 to heal, and monthly home-care costs estimated at US$ 25001.

 Study hypothesized that venous insufficiency could result from the interaction between two processes: tissue aging and abnormalities in the leukocyte/ endothelial cell interaction. These two processes, are believed to compound each other resulting in venous insufficiency2.

 Based on the available and most qualitative studies the overall prevalence of venous ulcers is, astonishingly stable between different countries and over time, around 1% in most populations. The point prevalence of open ulcers is more variable and is likely to be in the region of 0.1-0.3%3.

 Study concluded that compression sclerotherapy, the easiest and most effective way of treatment.The direct valve repairs are useful only in non thrombotic deep vein reflux. when compression slerotherapy fail, the insitu construction of new valve could help4.

 Skin grafting has decreased the limitation of function and improved the dysphoric mood. The coverage of ulcers by autografts of skin thickness, had decreased the leg pain within 6 months, significantly more than by conservative treatment alone. The amount of patients personal expenditure on the care and treatment of ulcers, increased within the period of 6 months for 11.2% of patients in whom large venous leg ulcer were treated conservatively. The amount of personal expenses decreased to 12.8% of patients in whom skin grafting was applied5.

 Study was done to quantify the effect of leg ulceration on health-related quality of life and to estimate a health state value for leg ulceration, concluding that leg ulcers

3 reduce quality of life to a similar extent as other common chronic conditions, such as arthritis and diabetes6.

 Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems. Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers7.

 Pinch skin grafting improves the rate of healing in large venous ulcers and is a simple technique that may be performed as an outpatient procedure under local anaesthesia8.

6.3 OBJECTIVES OF STUDY:  to analyze the incidence of Venous leg ulcers in different age groups and sex, among the patients admitted in KIMS HUBLI, surgery department.  to know the relationship between socio economic status and venous ulcers, to compare duration of ulcer and symptoms,  to evaluate the underlying cause, the recurrences rates and  to find out the best suited managment procedure

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA Data will be collected through a prescribed proforma from among the patients admitted in Department of General surgery, KIMS, Hubli with clinical diagnosis of venous leg ulcers during the period December 2010 to November 2011.

4 7..2 METHOD OF COLLECTION OF DATA This study will be prospective hospital based study conducted in KIMS, Hubli. All the cases which satisfy the inclusion criteria will be included in the study. Duration of study will be of one year from December 2010 to November 2011. Informed consent will be taken and the history, clinical, imaging and laboratory parameters will be recorded in predesigned data sheet.

Inclusion Criteria All the patients admitted with clinical diagnosis of venous leg ulcers above 12 yrs admitted to surgical department of KIMS Hubli.

Exclusion Criteria Patients not willing to give consent for study  Proven cases of arterial ulcers.  Traumatic ulcers.  Diabetic ulcers,  ulcers due to malignancy, neuropathic ulcers

Sample Size: All cases of venous leg ulcers admitted to surgical department of KIMS Hubli during the period from December 2010 to November 2011 will be taken for study as time bound study.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO DESCRIBE BRIEFLY. Yes,

5 Investigative profile available at KIMS, Hubli are:

Hb%, TC, DC, ESR B.Urea, S.Creatinine S.Albumin FBS, PPBS Urine routine C/S of the swab from the wound USG Abdomen, Venous Doppler of Lower limbs X-ray leg, and other relevant investigations if necessary

7.4 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? Yes, ethical clearance has been obtained from the ethical committee of KIMS Hubli.

8. LIST OF REFERENCES:

1)Laura L. Bolton , “Venous Ulcers” World Health Organisation’s Wound and lymphoedema management, 2010;chapter (9):103-107.

2) Julia Buján, Gemma Pascual, Juan M. Bellón, “ Interaction between ageing, inflammation process, and the occurrence of varicose veins” Phlebolymphology,2008;15(4):123-130.

6 3) Olle Nelzen,“Prevalence of venous leg ulcer: the importance of the data collection method“ Phlebolymphology,2008;15(4):143-150.

4)Cambal. M, Labas.P, “Venous leg ulcers – a surgical treatment” Bratisl Lek Listy,2008;109(9):391-395.

5) V. Jankunas, R. Bagdonas, D. Samsanavicius, R. Rimdeika Klaipeda, “The Influence of Surgical Treatment for Chronic Leg Ulcers on the Quality Dynamics of the Patient’s Life”Acta chir belg,2007;107:386-396.

6) Andrew jull, Natalie walker, Maree hackett, Mark jones, Anthony rodgers,Nicholas birchall, Robyn norton, Stephen macmahon,”Leg ulceration and perceived health: a population based case-control study”British Geriatric Society, Age and Ageing,2004;33:236-241

7) Nicky Cullum, Alison Fletcher,Anna Semlyen, Trevor A Sheldon “Compression therapy for venous leg ulcers” British Medical Journal,1997;6:226-231.

8)K.R.Poskitt, A.H.James, E.R.V.Lloyd-Davies, J.Walton, Charles McCollum.”Pinch skin grafting or porcine dermis in venous ulcers: a randomized clinical trial” British Medical Journal, 14 March 1987; vol 294: 674-676.

9) Aparajita Singh, Sajal Halder, Geetha R. Menon, Sunil Chumber, Mahesh Chandra Misra, Lalit Kumar Sharma and Anurag Srivastava “Meta-analysis of Randomized Controlled Trials on Hydrocolloid Occlusive Dressing Versus Conventional Gauze Dressing in the Healing of Chronic Wounds” Asian journal of surgery oct 2004;vol.27,no.4:326-332.

7 8 9 Signature of candidate

10 Remarks of guide

11 11.1 Name and designation of DR. M.B.BARIGIDAD M.S Guide PROFESSOR, DEPT OF GENERAL SURGERY, KIMS, HUBLI.

11.2 Signature

11.3 Head of the department DR.B.S.MADAKATTI M .S PROFESSOR & HEAD, DEPARTMENT OF SURGERY, KIMS, HUBLI.

11.4 Signature

12 Principal Name DR.U.S.HANGARGA, M.D. Principal phone number 0836 2374624 Principal email ID [email protected] Remarks of Principal Forwaded for needful. Principal signature

9 FROM, DR.MANAS BABU. B POST GRADUATE, DEPARTMENT OF GENERAL SURGERY, KIMS, HUBLI

TO, THE PRINCIPAL KIMS, HUBLI.

(THROUGH PROPER CHANNEL)

Respected sir, Sub: Submission of proforma for registration of subject for Dissertation. I am here with submitting my proforma for registration of dissertation titled “A STUDY OF VENOUS LEG ULCERS” Kindly forward this to RGUHS, Bangalore. Thanking you,

Yours sincerely,

DR. MANAS BABU. B

Place: Hubli Date:

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