“SURGICAL MANAGEMENT OF DIABETICS IN RURAL POPULATION”

Synopsis of the Dissertation

Submitted to

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

In partial fulfillment of the regulations for the Award of Degree of

MASTER OF SURGERY-GENERAL SURGERY

Submitted by

Dr. VIKRANT MAHAJANM.B.B.S.

Post Graduate in General Surgery

Under the guidance of

Dr. S.N. LINGE GOWDA

M.B.B.S, M.S, FRCS( Edin)

PROFESSOR

Department of General Surgery

SAH & R.C., B.G.NAGARA.

SRI ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA, NAGAMANGALA TALUK, MANDYA DISTRICT

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. VIKRANT MAHAJAN
NO. 107, KALPATARU BHAVAN,
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA-571448.
2. / NAME OF THE INSTITUTION / SRI ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B.G.NAGARA
3. / COURSE OF THE STUDY & SUBJECT /

M.S. IN GENERAL SURGERY

4. / DATE OF ADMISSION TO COURSE / 10th JUNE 2011
5. / TITLE OF THE TOPIC / “SURGICAL MANAGEMENT OF DIABETICS IN RURAL POPULATION”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF THE LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX – I
APPENDIX – IA
APPENDIX – IB
APPENDIX – IC
7. / MATERIALS AND METHODS
7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA-INCLUDING SAMPLING PROCEDURE IF ANY
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS; IF SO PLEASE DESCRIBE BRIEFLY
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION FOR THE ABOVE / APPENDIX – II
APPENDIX – IIA
APPENDIX – IIB
YES
APPENDIX – IIC
APPENDIX – IID
8. / LIST OF REFERENCES / APPENDIX – III
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / Diabetes is a common problem and its complications are faced by the surgeons. There is increased chance in rural population due to lack of education, change in lifestyle and negligence. This study is undertaken to bring down the reasons for above mentioned complications for the betterment of rural population. So, this will be useful to reduce the problems of major socio economic status.
11. / NAME AND DESIGNATION OF {IN BLOCK LETTERS}
11.1 NAME & DESIGNATION OF GUIDE /
Dr. S.N. LINGE GOWDA M.B.B.S, M.S, FRCS ( Edin)
PROFESSOR
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA.
11.2 SIGNATURE OF GUIDE
11.3 CO-GUIDE (IF ANY) / No
11.4 HEAD OF DEPARTMENT /
Dr. R. SRINATH M.B.B.S., M.S.,
PROFESSOR AND HEAD
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA.
11.2 SIGNATURE /
12 / 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL / Dr. SHIVARAMU. M.G., M.B.B.S., M.D.
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE

APPENDIX - I

6. BRIEF RESUME OF INTENDED WORK

APPENDIX - IA

6.1 NEED FOR THE STUDY:

There is increase in incidence of diabetes and its complications in rural population as compared to earlier in urban population.

The usual presentation is with uncontrolled state of diabetes and its complications.

Hence the need for study is to advice the patients in rural population regarding the early detection by explaining the symptoms and to educate them for regular checkups and change in lifestyle for good control of diabetes, so that the complications which lead to poor prognosis and loss of parts etc. can be avoided. A good life can be achieved and high quality of survival can be obtained.

APPENDIX - IIB

6.2 REVIEW OF LITERATURE

  • Diabetes mellitus is a metabolic disorder characterized by increased fasting and postprandial concentrations of glucose. Type 1 diabetes is characterized by deficiency of insulin secretion by of the islets of pancreas due to many reasons. Type 2 diabetes is characterized by defective insulin secretion and action.1
  • In the First Century B.C. – Diabetes received its name from a Greek physician, Aretaeus of Cappadocia, after the word dia-bainein which means “to siphon”. This was related to the patients passing excessive amounts of urine.13
  • In ancient times – Indians would call diabetes “sweet urine disease” because they tested for it by observing whether ants were attracted to the persons urine or not.2
  • 1988 – Dr. Gerald Reaven identifies metabolic syndrome, which is a combination of medical disorders that increase the risk of a diabetes diagnosis.5
  • Diabetes Mellitus is best known metabolic disorder contributing to increased rate of wound infection and failure. Duration of diabetes and poor glycaemic control are most closely associated with vascular complications.4
  • Cutaneous skin infections are often a presenting feature of poorly controlled Type 2 Diabetes. Typical infections include candidiasis as well as cellulitis furuncles and carbuncles (caused by Staphylococcus aureus infection). Advanced cases have infections of deeper structures including bone.6
  • Diabetic foot infections range from local fungal infections of the nails to necrotizing limb- or life-threatening infections.3
  • Complications include ulcers, gangrene (mostly moist gangrene). Trophic ulcers ,bed sores, mesenteric ischemia leading to visceral complications.10
  • 10-15% of diabetic’s patients run the risk of developing ulcers. The major contributory factors to formation of diabetic ulcers include neuropathy, foot deformity and ischaemia. It is estimated 60-70%of diabetic ulcers are due to neuropathy, 15-20% are due to ischaemia and 15-20% are due to combination of both.7
  • Infections in patients with diabetes are difficult to treat because these individuals have impaired micro vascular circulation, which limits the access of phagocytic cells to the infected area and results in a poor concentration of antibiotics in the infected tissues.9
  • The treatment of diabetic wounds involves local and systemic measures. Most diabetic wounds are infective and eradication of infectious source is the paramount to the success of healing, wide debridement of all the necrotic or infected tissue is the cornerstone of treatment. The removal of devitalized tissue to control infection and creation of an environment favorable for healing, while maximizing the structural and physical integrity of the foot, is the central goal of surgical intervention in treating diabetic foot infections.8
  • Surgical procedures span a range from simple outpatient debridements to guillotine amputations in diabetics with life-threatening infections.12
  • Careful monitoring, preventative measures, altering the weight-bearing surface of the foot, liberal debridements to control local infections, antibiotics and creation of an environment conducive to healing will remain the foundation of good foot care in diabetic patients.14
APPENDIX - IC

6.3 AIMS AND OBJECTIVES

To study:

  • The incidence of diabetic patients requiring surgical management with special relation to age, sex and lifestyle with special reference to rural population.
  • Various modes of presentation of complications in diabetics.
  • To educate the patients in rural population, the advantages of early detection, good control of diabetes, to prevent the complications.
  • Various factors responsible for primary prevention of surgical management.
  • Treatment options currently available and the changing trend.
  • The outcome following surgical management.

APPENDIX - II

7. MATERIALS AND METHODS

APPENDIX - IIA

7.1 SOURCE OF DATA:

The material for the present study is proposed to be collected from minimum of 100 patients attended at Sri Adichunchanagiri Hospital & Research Centre, B.G.Nagara attached to Adichunchanagiri Institute of Medical sciences B.G.Nagara from July 2011 to October 2013.

APPENDIX - IIB

7.2 METHOD OF DATA COLLECTION:

  • Data will be collected from patients who are attended in surgery OPD and admitted in surgery wards of SAH & RC.
  • Clinical study will be through questionnaires and clinical examination.
  • All patients will undergo routine and special investigations.
  • Surgical management of complications.
  • Post-operative observation of patients for any complications.
  • Regular follow up and health education for the patients treated.

INCLUSION CRITERIA :

  • All diabetic patients admitted in surgical wards with surgical complications.
  • All diabetic patients seen on OPD basis with surgical complications.
  • Patient with carbuncle, infections of foot, neurovascular complications leading to trophic changes and ischaemia irrespective of the age, sex, and socioeconomic status.
EXCLUSION CRITERIA
  • Only pediatric cases

APPENDIX - IIC

7.3 Does the study require any investigations or interventions to be conducted on patients or other animals; if so describe briefly:

YES

INVESTIGATIONS:

1.Blood

  • Total count.
  • Differential count.
  • Hemoglobin.
  • Random Blood Glucose
  • Fasting and past-prandial Blood Glucose
  • Glycosylated hemoglobin(HbA1C)
  • Blood urea
  • Serum creatinine
  1. Urine routine.
  2. Plain radiographs
  3. Culture and sensitivity of pus and infected tissue-bacteriological and fungal
  4. Tissue biopsy wherever applicable

Special investigations like

  • Vascular Doppler scan
  • CT and MRI if indicated.

No animal studies are conducted in this study.

APPENDIX – II D

7.4 PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A
a / Title of the study / “SURGICAL MANAGEMENT OF DIABETICS IN RURAL POPULATION”
b / Principle investigator
(Name and Designation) / Dr. VIKRANT MAHAJAN
NO. 107, NEW KALPATARU BHAVAN,
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA-571448.
c / Co-investigator
(Name and Designation) /
Dr. S.N. LINGE GOWDA
M.B.B.S, M.S, FRCS ( Edin)
PROFESSOR
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA.
d / Name of the Collaborating
Department/Institutions / NA
e / Whether permission has been obtained from the heads of the collaborating departments & Institution / YES
Section – B
Summary of the Project / APPENDIX I
Section – C
Objectives of the study / APPENDIX IC
Section – D
Methodology / APPENDIX IIB
A / Where the proposed study will be undertaken / SAH & RC, B.G.NAGARA
B / Duration of the Project /
18 MONTHS
C / Nature of the subjects:
Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
NO
NO
NO
D / If the study involves health volunteers
  1. Will they be institute students?
  2. Will they be institute employees?
  3. Will they be Paid?
  4. If they are to be paid, how much per session?
/ NO
NO
NA
NA
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trial been approved by the ethics Committee of the other centers?
If the study involves the use of drugs please indicate whether.
I. The drug is marketed in India for the indication in which it will be used in the study.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
Use of the drug in healthy volunteers
Use of the drug in-patients for a new indication.
Phase one and two clinical trials
Experimental use in-patients and healthy volunteers. / NA
NA
NA
NA
NA
NA
NA
NA
G / How do you propose to obtain the drug to be used in the study?
-Gift from a drug company
-Hospital supplies
-Patients will be asked to purchase
-Other sources (Explain) / NA
H / Funding (If any) for the project please state
-None
-Amount
-Source
-To whom payable / NIL
I / Does any agency have a vested interest in the out come of the Project? / NO
J / Will data relating to subjects /controls be stored in a computer? / YES
K / Will the data analysis be done by
-The researcher?
-The funding agent / YES
NO
L / Will technical / nursing help be required form the staff of hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the study?
If Yes give details of
  1. Designation
  2. Qualification
  3. Number
  4. Duration of Employment
/ YES, but it will not interfere with their duties.
NA
M / Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent? Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason: / YES
YES
NO
NO
NO
N / Describe design, Methodology and techniques / APPENDIX II

Ethical clearance has been accorded.

Chairman,

P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.

Date :

PS : NA – Not Applicable

APPENDIX – III

LIST OF REFERENCES
  1. Seminar Review: A Review of the Basis of Surgical Treatment of Diabetic Foot Infections International Journal of Lower Extremity Wounds March 2011 10: 33-65
  2. Furdell, Elizabeth Lane. Fatal Thirst: Diabetes in Britain until Insulin (Leiden, Netherlands: Brill, 2009) 194 pp
  3. C.Ronald Kahn,Gordon C.Weir, George, L.King, Alan, M. Jacobson, Alan, C. Moses, Robert. J. Smith, Joslin's Diabetes Mellitus (2009)
  4. Fauci, Braunwald, Kasper, Hauser, Longo, Jameson, Loscalzo. harrisons principle of internal medicine (2008); Diabetes Mellitus, 2275-2304
  5. AMERICAN DIABETES ASSOCIATION: Clinical practice recommendations 2007. Diabetes Care 30:S4, 2007
  6. GROSS JL et al: Diabetic nephropathy: Diagnosis, prevention, and treatment. Diabetes Care 28:164, 2005
  7. Wild S, Roglic G, Green A, Sicree R, King H (May 2004). "Global prevalence of diabetes: estimates for 2000 and projections for 2030". Diabetes Care 27 (5): 1047–53.
  8. Mitchell, Richard Sheppard; Kumar, Vinay; Abbas, Abul K.; Fausto, Nelson. Robbins Basic Pathology. Philadelphia: Saunders.8th edition.
  9. Thomas M. Habermann, Amit K. Ghosh. Mayo Clinic internal medicine concise textbook 171-216.
  10. Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. Nov 12 2005;366(9498):1695-703.
  11. Bridges R M, Deitch E A. Diabetic Foot Infections: Pathophysiology and Treatment. Surg Clin North Am. (1994);74:537–555.
  12. Caputo G M, Cavanagh P R, Ulbrecht J S, Gibbons G W, Karchmer A W. Assessment and management of foot disease in patients with diabetes. NEJM. (1994);331:854–860.
  13. Medvei, Victor Cornelius (1993). The history of clinical endocrinology. Carnforth, Lancs., U.K: Parthenon Pub. Group. pp.23–34.
  14. The Diabetes Control And Complications Trial Research Group (September 1993). "The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group". The New England Journal of Medicine 329 (14): 977–86

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