RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE --II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

(To be submitted in duplicate)

1. Name of the Candidate and DR. ADRIANNA D’MELLO

Address 12 XAVIER HOUSE,

ST. PETER’S COOP SOCIETY,

31A PALI ROAD,

BANDRA,

MUMBAI 400-050

2. Name of the Institution M.S. RAMAIAH MEDICAL

COLLEGE AND TEACHING

HOSPITAL, BANGALORE

3. Course of study and subject M.S. GENERAL SURGERY

4. Date of admission to course 04/05/2009

Date of commencement of course 04/05/2009

5. Title of the topic DVT RISK STRATIFICATION

OF PATIENTS UNDERGOING

SURGICAL PROCEDURES IN

M.S. RAMAIAH HOSPITALS.

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 INTRODUCTION AND NEED FOR THE STUDY:

Deep vein thrombosis (DVT) is defined as the formation of a blood clot (thrombus) that blocks a deep vein. It is a form of thrombophlebitis (inflammation of a vein with clot formation). Virchow’s triad of venous stasis, vessel wall injury and hypercoagulable state are considered the primary mechanisms for the development of DVT 1.

Venous thromboembolism (VTE) remains a widespread clinical problem associated with significant morbidity and mortality. The exact incidence of VTE unknown, but estimated at 900,000/y and it accounts for 600,000 hospitalizations per year in the US alone. Death from DVT is usually due to massive pulmonary embolism (PE) (200,000/y in US) 2.

Untreated, deep vein thrombosis (DVT) predisposes patients to episodes of recurrent VTE and the development of the postphlebitic syndrome (PTS), which can have a variety of symptoms ranging from leg edema, pain, aching and tiredness, to the development of skin discoloration, scarring, and even open ulceration 3.

Surgical patients in particular are at a high risk for DVT since the surgical procedure itself is very traumatic and often accompanied by bed rest that increases venous stasis. Without appropriate prophylaxis, DVT rates range from 45–70% and 15–30% in orthopaedic and general surgery patients respectively. For this reason, surgeons should be aware of current guidelines that detail how to appropriately protect their patients from the development of DVT. The rationale for VTE prophylaxis is based on the fact that two-thirds of DVT cases are asymptomatic, and PE is most often clinically silent. In addition, the clinical diagnosis of a DVT or PE is insensitive and unreliable since few of their signs and symptoms are specific. Implementation of treatment must be done before the complete clinical picture has developed, since the first manifestation of the disease may be a fatal PE. Consequently, prevention is the key to reducing death and morbidity from VTE, and the key to appropriate prophylaxis is risk factor analysis (RFA) 3.

Hence the present study is being undertaken to determine the risk of developing DVT in surgical patients, the adequacy of prophylaxis being administered and thus the awareness of surgeons regarding the same.

6.2 REVIEW OF LITERATURE:

Even though the importance of preventing the development of DVT has been emphasized by a number of consensus conference guidelines over the past 20 years, the specific recommendations in the guidelines have not yet been universally adopted into clinical practice. Various surveys over the past few years have reported wide practice variations in the prevention of DVT, including an under-utilization of prophylaxis and a lack of awareness among physicians of DVT as a problem. In a 1998 survey of 1,145 Fellows of the American College of Surgeons, Caprini showed that only 47% and 31% of the responding surgeons were familiar with the1986 NIH Consensus Conference and the American College of Chest Physicians guidelines respectively. And 90% of the surgeons were not familiar with the 1992 THRIFT Conference or the 1992 European Consensus Conference Guidelines 3.

In a study conducted by Bahal V and Silverman SH, all surgeons claimed to use DVT prophylaxis and were largely aware of the accepted risk factors, however no consensus existed in allocating a level of risk to individual imaginary cases. The conclusion reached was that in spite of being aware of risk factors, similar patients are being dealt with in widely different ways by different clinicians, emphasizing the need to formally assess each individual patient's DVT risk and prescribe prophylaxis accordingly 4.

Motykie GD et al carried out a study on risk factor assessment and venous duplex scanning on 1,000 patients with clinically suspected lower extremity deep vein thrombosis. They concluded that while venous duplex scanning was established as the screening test of choice when the diagnosis of DVT was suspected, there was a significant cost involved in performing and interpreting the test and suggested that a better clinical model utilizing risk factor assessment was the key to increasing the yield rate and cost-effectiveness of venous duplex scanning by excluding low-risk patients from undergoing unnecessary testing 5.

In a study conducted by O'Flaherty M, only 63% of doctors accurately evaluated DVT risk and implemented prophylactic strategies. There was poor agreement in the evaluation of risk for postoperative DVT, and in cases of low and moderate risk of DVT, agreement was the least. They also found that the overall accuracy of DVT prophylaxis strategy was only moderate and risk evaluation did not correlate with the selection of the strategy 6.

In a study conducted by Dr. Alexander T. Cohen et al on 68,183 patients, 52% of enrolled hospital in-patients were judged to be at risk for VTE of which 64% were surgical patients and of these surgical patients at risk, only 59% received ACCP-recommended DVT prophylaxis. Hence the study demonstrated the high prevalence of patients at risk for DVT and the low rate of prophylaxis use 7.

6.3 OBJECTIVES OF THE STUDY:

To stratify patients at risk for development of deep vein thrombosis among patients undergoing surgical procedures irrespective of specialty.

To additionally determine the proportion of at risk hospital patients who receive effective types of DVT prophylaxis.

7 MATERIALS AND METHODS:

7.1 SOURCE OF DATA: Patients undergoing surgical procedures irrespective of specialty in M.S. Ramaiah Hospitals.

7.2 METHOD OF DATA COLLECTION: This is a cross-sectional observational study conducted on 400 patients undergoing surgical procedures in M.S. Ramaiah Hospitals. All patients aged 18 years or older undergoing surgical procedures under general, spinal, epidural or regional anesthesia will be included in this study. On one day of a week other than Saturday, Sunday or holiday, which is randomly chosen, all patients undergoing surgery irrespective of specialty (aged 18 years or older undergoing surgical procedures under general, spinal, epidural or regional anesthesia) will be assessed for risk of DVT on the basis of hospital chart review including medical history, current medical conditions, type of surgery, initiation and type of DVT prophylaxis. The American College of Chest Physicians (ACCP) evidence-based consensus guidelines will be used to assess DVT risk and to determine whether patients are receiving the recommended prophylaxis. No identifiable patient data will be transmitted outside of the study.

INCLUSION CRITERIA:

• Patients aged 18 years or older undergoing surgical procedures under general, spinal, epidural or regional anaesthesia.

EXCLUSION CRITERIA:

• Patients undergoing surgical procedures under local anaesthesia

• Those patients already on DVT treatment

STUDY DESIGN:

Hospital-based, cross-sectional observational study.

STATISTICAL ANALYSIS:

The data collected will be entered in MS excel and analyzed using SPSS vide.

Descriptive statistics: will be applied to analyze the socio-demographic, baseline clinical and laboratory characteristics of the study subjects.

Qualitative data will be expressed as frequency and percentages.

Quantitative data will be presented as mean and standard deviation.

Analytical statistics:

The mean risk scores of the patients studied will be presented as mean and standard deviation.

The risk status of the patients would be classified based on the risk scores into mild, moderate and severe and will be presented as frequency and percentages respectively

The frequency of patients receiving appropriate DVT prophylaxis in each of the risk category will be expressed as frequency and percentages.

The chi square test will be applied to test for any significance in the people who are at risk and those receiving prophylaxis.

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

a. ROUTINE INVESTIGATIONS: - nil

b. SPECIAL INVESTIGATIONS: - no Duplex scan required as this is for DVT risk stratification only.

c. NO ANIMALS WILL BE USED IN THIS STUDY.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?

Yes, the certificate of the same has been enclosed.

Department: ___________ Proforma no.: __________

Hospital no.: ___________

1. Sex:  Male  Female 2. Year of birth: 19___

3. Weight (kgs): ____ 4. Height (cms): ____

5. Date of survey: 6. Date of hospital admission:

___/____/______ ___/____/______

7. A (each item represents 1 risk factor):

Minor surgery  Inflammatory bowel disease 

Age 40-60 years  Obesity (>20% of idea BW) 

Pregnancy or postpartum (72hours 

Major surgery  Central venous access 

9. C (each item represents 3 risk factors):

History of DVT/PE  Antithrombin III deficiency 

Myocardial infarction  Proteins C and S deficiency 

Congestive heart failure  Dysfibrinogenemia 

Severe sepsis/infection  Homocysteinemia 

20210A Prothrombin mutation  Antiphospholipid antibodies 

Lupus anticoagulant  Myeloproliferative disorders 

Factor V Leiden/Activated protein C resistance 

Disorders of plasminogen and plasmin activation 

Heparin-induced thrombocytopenia 

Hyperviscosity syndromes 

Duration of surgery - 45mins 

10. D (each item represents 5 risk factors):

Elective major lower extremity arthroplasty  Stroke 

Hip, pelvis or leg fracture  Multiple trauma 

Acute spinal cord injury 

11. Reason for admission:

12. Type of prophylaxis:

Pharmacological 

Mechanical 

Both 

None 

13. Type of prophylaxis or reason for not giving prophylaxis:

8 REFERENCES:

1. Bailey and Love’s Short Practice of Surgery, Chapter 54 – Venous disorders, Kevin Burnand, Hodder Arnold, Hachette UK, 2008, p 935.

2. Rondi Gelbard, 2008, Venous Thromboembolism Prophylaxis, Standard of Care Conference, Columbia University Medical Center, p 5-6.

3. Gary D. Motykie, Lukas P. Zebala, Joseph A. Caprini, Chris E. Lee, Juan I. Arcelus, J.J. Reyna et al, A Guide to Venous Thromboembolism Risk Factor Assessment, 2000, Journal of Thrombosis and Thrombolysis, p 253-262.

4. Bahal V, Silverman SH. The case for formal stratification analysis when prescribing deep vein thrombosis prophylaxis - 1993. J R Coll Surg Edinb, p 33-5.

Motykie GD, Caprini JA, Arcelus JI, Zebala LP, Lee CE, Finke NM, Tamhane A, Reyna JJ. Risk factor assessment in the management of patients with suspected deep venous thrombosis - 2000. Int Angiol; 19(1):47-51.[pic]

5. O'Flaherty M, Lerum K, Martin P, Grassi D. Low agreement for assessing the risk of postoperative deep venous thrombosis when deciding prophylaxis strategies: a study using clinical vignettes - 2002. BMC Health Serv Res. 16;2(1):16.

6. Dr. Alexander T. Cohen, Victor F. Tapson, Prof Jean-Francois Bergmann, Prof Samuel Z. Goldhaber, Prof Ajay K. Kakkar, Bruno Deslanders and et al. Venous Thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study - 2008. The Lancet, Volume 371, Issue 9610, Pages 387-394.

9 SIGNATURE OF THE CANDIDATE:

10 REMARKS OF THE GUIDE:

Good clinical study.

11 REMARKS OF THE CO-GUIDE:

DVT is becoming a major morbidity and mortality cause and this study may show the prevalence and awareness.

12 NAME AND DESIGNATION OF

12.1 GUIDE Dr. KULKARNI S. V.

PROFESSOR & HEAD OF UNIT

DEPARTMENT OF SURGERY

M.S. RAMAIAH MEDICAL COLLEGE

12.2 SIGNATURE

12.3 CO - GUIDE Dr. SANJAY DESAI

PROFESSOR & HEAD OF DEPARTMENT

DEPARTMENT OF VASCULAR SURGERY

M.S. RAMAIAH MEDICAL COLLEGE

12.4 SIGNATURE

12.5 HEAD OF DEPARTMENT Dr. M.R. SREEVATHSA

PROFESSOR AND HOD

DEPARTMENT OF SURGERY

M.S. RAMAIAH MEDICAL

COLLEGE

12.6 SIGNATURE

13 REMARKS OF THE

13.1 CHAIRMAN AND PRINCIPAL

13.2 SIGNATURE

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