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“CLINICAL STUDY OF PRIMARY VARICOSE
VEINS and ITS COMPLICATIONS IN RURAL
PEOPLE”
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. K.V. EDVINE, M.B.B.S.
Post Graduate in General Surgery
Under the guidance of
Dr. G.LAXMINARAYAN
MB.B.S., M.S.,
PROFESSOR
Department of General Surgery
SAH and 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
2.
NAME OF THE INSTITUTION
3.
COURSE OF THE STUDY and SUBJECT
M.S. IN GENERAL SURGERY
4.
DATE OF ADMISSION TO COURSE
4th JUNE 2012
5.
Dr. K.V. EDVINE
NO. 94, KALPATARU BHAVAN,
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA - 571448.
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA
TITLE OF THE TOPIC
BRIEF RESUME OF THE INTENDED WORK
6.
“CLINICAL STUDY OF PRIMARY
VARICOSE VEINS and ITS
COMPLICATIONS IN RURAL
PEOPLE”
APPENDIX – I
6.1 NEED FOR THE STUDY
APPENDIX – IA
6.2 REVIEW OF THE LITERATURE
APPENDIX – IB
6.3 OBJECTIVES OF THE STUDY
APPENDIX – IC
MATERIALS AND METHODS
APPENDIX – II
7.
7.1 SOURCE OF DATA
APPENDIX – IIA
7.2 METHOD OF COLLECTION OF DATAINCLUDING SAMPLING PROCEDURE IF
ANY
APPENDIX – IIB
7.3 DOES THE STUDY REQUIRE ANY
INVESTIGATIONS OR INTERVENTIONS
TO BE CONDUCTED ON PATIENTS OR
OTHER ANIMALS; IF SO PLEASE
DESCRIBE BRIEFLY
APPENDIX – IIC
7.4 HAS ETHICAL CLEARANCE BEEN
OBTAINED FROM YOUR INSTITUTION
FOR THE ABOVE
APPENDIX – IID
8.
LIST OF REFERENCES
APPENDIX – III
9.
SIGNATURE OF THE CANDIDATE
1
10. REMARKS OF THE GUIDE
The proposed study is being done to learn about
the clinical presentation and complication of
primary varicose veins in rural areas.
11. NAME AND DESIGNATION OF
{IN BLOCK LETTERS}
11.1 NAME and DESIGNATION OF
GUIDE
Dr. G. LAXMINARAYAN MBBS, MS
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 MB.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
and PRINCIPAL
The facilities required for the investigation will be
made available by the college
Dr. SHIVARAMU. M.G., M.B.B.S., M.D.
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
2
APPENDIX - I
6. BRIEF RESUME OF INTENDED WORK
APPENDIX - IA
6.1 NEED FOR THE STUDY:
Varicosity is the penalty for verticality against gravity. Varicose vein involves at least
1 out of 5 in the world. Though considerable advances in understanding of venous patho
physiology and modern imaging techniques have revolutionized the concept of management
of varicosity of lower limb, whether these inferences hold good for our population is
pertinent question
Varicose veins have been recognized as chronic disorder since ancient times. Though
varicose veins were recognized pre historically, only in the present century considerable
knowledge has been gained concerning the anatomy of venous system of the leg, the
physiological mechanism of venous return to heart against gravity and pathology of the
disorder, which leads to many newer modalities of treatment. Our understanding of the
fundamental pathologic processes has advanced considerably in the last decade and a
reappraisal of these diseases is now needed. Technological advances in particular color
duplex ultrasonography now offers improved diagnostic accuracy in patients with venous
diseases. This should be the minimum investigation before undertaking any operation for
venous diseases of the lower limb. Venous ulceration may be partially attributable to failure
of the microcirculation of the skin to provide nutrition, but inflammatory mediators and toxic
products from inflammatory cells probably play a major part in causing the skin damage.
This study is to identify all admissions with primary varicose veins, to evaluate
patients having primary varicose veins with appropriate investigations and recognize
complications, to collect data and to study pattern and establish the clinical spectrum of
3
complications in this population and to finally suggest measures to improve patients
understanding in order to prevent complications.
APPENDIX - IIB
6.2 REVIEW OF LITERATURE
Primary varicose veins are bothersome, particularly when associated with
complications such as lipodermatosclerosis and ulceration. Valvular incompetence of
superficial and perforating veins is considered the main pathological feature. Because the
patients with varicose veins may have Valvular incompetence in the superficial, perforating
and deep venous system alone, or in combination it is difficult to determine which
abnormality has maximum bearing on complications. With the application of duplex color
Doppler imaging the incidence and anatomical distribution of venous reflux can be
determined non-invasively in patients with varicose veins. Accurate non-invasive evaluation
using duplex color Doppler ultrasonography helps to determine the best operative strategy3.
Venous veins affect 3 times more in women than men. Chronic venous insufficiency
and venous ulceration affects atleast 1% of population with greatly increased prevalence over
the age of 65 years. Many operations have been described, but restorative surgery of deep
veins remains largely experimental and applicable to only a small section of population of
patients with chronic venous insufficiency. Where skilled technologist is available with
experience in venous imaging, color Doppler ultrasonography is investigation of choice.5
The first written reference of varicose veins appears to Ebsers Papyrus dated 1550
B.C. The treatment of varicose veins has developed over a period of more than 3000years.6
Cornelious Celsius (53 B.C. -and A.D.) made multiple incision along the varicosity
four finger breadth apart and touched the vein with a cautery through each incision and
grasped the ends of the vein and extracted as much as veins he could.
4
Aurolius Tornelius (25 B.C. – 50 A.D.) advised the use of plasters for the leg ulcers
and linen roller bandages. He treated them by exposure followed by avulsion with a blunt
hook or by a touch of the cautery.
Claudius Galen (130 A.D. – 200A.D.) removed varicose veins with a hook. He also
developed a method of bandaging which held the wound edges together. Galen’s theory of
circulation remained standard theory for next 1400 years.
Paulus Aegineta (607 – 690 A.D.) performed ligation of varicose veins on inner
aspect of the thighs.
William Harvey (1578 – 1657) proposed theory of blood circulation and said blood
flows in one direction.
The first to ligate varicose veins seems to have been the Byzantine physician Aetius
of Amida on the Tigris (502-575).
Friedrich Trendelenberg (1841 – 1891) described a transverse incision at the junction
of upper and middle 3rd of the thigh and ligated vein in the mid-thigh
George Perthe (1869 – 1927) introduced a test to decide the patency of deep veins.
Keller (1905) was first to think about stripping and introduced stripping. Later
modified by Mayo(1906) and Bab Cock (1907).
Fagan (1967) introduced compression sclerotherapy.
Cocket and Dodd(1974) subfascial ligation of perforators.
Hauer(1985) pioneered subfascial endoscopic perforator ligation.
5
Studies by Goutham and Satish in 2009 showed that meticulous clinical examination
and surgical technique followed by closely monitored post operative management is required
to reduce morbidity of varicose veins.
The history of varicose veins and leg ulcers when traced has noted the influence of
various theories4, which are,
1. The humoral theory
2. The mechanical theory
3. The pathophysiological theory
THE HUMORAL THEORY
Galen,s theory of humours taken from Hippocrates, together with the idea of to and
fro movements of blood with its various spirits dominated medical thought for fifteen
centuries. Varicose was attributed to weight of stagnant ‘gross’ blood on the walls of veins.
Haly Abbas believed they were filled with black bile and occurred in those who worked hard
and stood long. France and Heister (1768) considered ulcer to be a drain for humors which if
not expelled, would cause serious illness
THE MECHANICAL THEORY
Humoral theory received a blow when Harvey discovered the circulation of the blood
and found out vessels contain valves. He came to 2 conclusions, the blood movement is not
possible to and fro, and blood was pumped throughout the body by heart. Wiseman 1678
realized the valvular incompetence results from dilation of vein and considered ulcers might
be the direct result of a circulation defect and used the term ‘venous ulcer’. Whites and
Dionis attributed the varicose veins in pregnant women to the pressure of the uterus on the
iliac veins.
6
THE PATHOPHYSIOLOGICAL APPROACH
Gay’s (1812 -1885) work appears to be the first scientific investigation of these
conditions. He pointed out that there may be other serious lesions affecting both arteries and
veins, deep and superficial and believed that venous thrombosis played an important role.
Harvey and Lower gave the concept of leg muscle pump theory.
APPENDIX - IC
6.3 AIMS AND OBJECTIVES

To identify all admissions with primary varicose veins

To evaluate patients having primary varicose veins with appropriate investigations
and recognize complications.

To collect data and establish the clinical spectrum and study of complications in this
population.

To suggest measures to improve patients understanding in order to prevent
complications.
7
APPENDIX - II
7. MATERIALS AND METHODS
APPENDIX - IIA
7.1 SOURCE OF DATA:
This is a prospective study of patients who present with symptoms of primary
varicose veins to Adichunchanagiri Institute of Medical Sciences, B.G Nagara for 2years.
APPENDIX - IIB
7.2 METHOD OF DATA COLLECTION:

Detailed history taking

Complete clinical examination

Investigations-Appendix-IIC

Performing surgery for the cases
INCLUSION CRITERIA :

Patients aged between 20 to 80 yrs

Includes both males and females

All patients with dilated and engorged vessels were investigated

Patients with SFJ incompetence and SPJ incompetence
EXCLUSION CRITERIA
Patients with secondary varicose veins like those with:

Arteriovenous fistula

Iliac vein thrombosis

Pelvic tumor

Pregnant females
8
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, it requires the following investigations to be conducted on patients included in the
study.
INVESTIGATIONS

Routine investigations:
o Hemoglobin percentage
o Total WBC count
o Differential WBC count
o Erythrocyte sedimentation rate
o Platelet count
o Bleeding time
o Clotting time
o Urine for protein, sugar and microscopy
o Random blood sugar
o Blood urea
o Serum creatinine

Specific investigations:
o Venous and Arterial Doppler
o Duplex USG
o Non-invasive imaging methods – ultrasound

Color flow Doppler ultrasound
9
INTERVENTION

Sclerotherapy

Sapheno-femoral ligation (Trendelenburgh procedure of high ligation).

Stripping of long saphenous vein.

Sequential avulsion

Multiple Phlebotomies

Sapheno-popliteal ligation

Perforator ligation

SEPS (subfacial endoscopic perforator ligation)
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APPENDIX – II D
7.4 PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
a
b
Principle investigator
(Name and Designation)
c
Co-investigator
(Name and Designation)
d
Name of the Collaborating
Department/Institutions
e
A
“CLINICAL STUDY OF PRIMARY
VARICOSE VEINS and ITS
COMPLICATIONS IN RURAL PEOPLE”
Title of the study
Dr. K.V. EDVINE
NO. 94, KALPATARU BHAVAN,
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA - 571448.
Dr. G. LAXMINARAYAN MBBS, MS
PROFESSOR
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S., B.G.NAGARA
Whether permission has been obtained from
the heads of the collaborating departments
and Institution
Section – B
Summary of the Project
YES
APPENDIX I
Section – C
Objectives of the study
APPENDIX IC
Section – D
Methodology
APPENDIX IIB
Where the proposed study will be
undertaken
SAH and RC, B.G.NAGARA
B Duration of the Project
18 MONTHS
C Nature of the subjects:
Does the study involve adult patients?
YES
Does the study involve Children?
NO
Does the study involve normal volunteers?
NO
Does the study involve Psychiatric patients?
NO
Does the study involve pregnant women?
NO
11
D If the study involves health volunteers
I.
Will they be institute students?
NO
II. Will they be institute employees?
NA
III. Will they be Paid?
NA
IV. If they are to be paid, how much per
NA
session?
E Is the study a part of multi central trial?
NO
F If yes, who is the coordinator?
(Name and Designation)
NO
Has the trial been approved by the ethics
Committee of the other centers?
NO
If the study involves the use of drugs please
indicate whether.
NA
I. The drug is marketed in India for the
indication in which it will be used in the study.
NA
II. The drug is marketed in India but not for the
indication in which it will be used in the study
NA
III. The drug is only used for experimental use
in humans.
NA
IV. Clearance of the drugs controller of India
has been obtained for:
NA
 Use of the drug in healthy volunteers
 Use of the drug in-patients for a new
indication.
 Phase one and two clinical trials
NA
 Experimental use in-patients and healthy
volunteers.
12
G How do you propose to obtain the drug to be
used in the study?
-
Gift from a drug company
NO
-
Hospital supplies
NO
-
Patients will be asked to purchase
NO
-
Other sources (Explain)
NO
H Funding (If any) for the project please state
-
None
-
Amount
-
Source
-
To whom payable
NA
Does any agency have a vested interest in the
I
NO
out come of the Project?
Will data relating to subjects /controls be stored
J
NO
in a computer?
Will the data analysis be done by
K
-
The researcher?
YES
-
The funding agent
NO
L Will technical / nursing help be required form
the staff of hospital.
YES
If yes, will it interfere with their duties?
NA
Will you recruit other staff for the duration of
NA
the study?
If Yes give details of
I.
Designation
II.
Qualification
III.
Number
IV.
Duration of Employment
NA
13
M Will informed consent be taken? If yes
NO
Will it be written informed consent:
NA
Will it be oral consent?
NA
Will it be taken from the subject themselves?
NA
Will it be from the legal guardian? If no, give
NA
reason:
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
14
APPENDIX – III
LIST OF REFERENCES
1. Philip D Coleridge Smith: modern approaches to venous disease: Recent advances in
surgery, 125-139.
2. David J Tibbs. Venous Disorders, Vascular Malformations and Chronic ulcerations in
the lower limbs, “Oxford text book of surgery”, 2nd edition, edited by Peter J. <orris
and William C. wood, Vol 1, pg 959-1000.
3. T. Sakurai, P.C.Gupta, M.Matshushita, N.Nishikimi and Y.Nimura :Correlation of the
anatomical distribution of venous reflux with clinical symptoms and venous
haemodynamics in primary varicose veins: Br J Surg, Feb- 1998, vol 85,213-216.
4. Dodd H.J, Cockett F.B. The Pathology and Surgery of the veins of the lower limb. 2nd
Edn, Churchill Livingstone; 1976.
5. John H. Scurr and Philip d. Coleridge Smith. “Bailey and Love’s Short practice of
surgery”, 25th Edition, Edited by R.C.G. Russell, Norman S. Williams, and
Christopher J. K. Bulstrode, Chapter16,pg.235-255.
6. Johnson G, Jr. ‘Management Of Venous Disorders’. In Vascular surgery by
Rutherford RB, 4th Edn. Vol II, W.B. Sounders company;1995: 1671-1862.
7. Das S, ‘Examination of Varicose Veins’, in Clinical Das. SB publications, Ch. 10;
Edn 4th: 1998: 73-79.
8. John J, Geert W, Philip D, Andrew N, Michel R:Chronic Venous Disease:New Eng
Jour of Med, Aug 2006,488-498.
9. Vashist, Vijay M, Nitin S:Role of Subfascial Endoscopic perforator Surgery in
Management of Perforator Incompetence in Varicose Veins:Indian J Surg, July, 2012
10. Goutham R K, Satish B, Gurjit S:Varicose veins:clinical presentation and surgical
management: Indian J Surg, May-June 2009,71:117-120
15
11. Sundeep K, Pabitra G, Prasenjit M: Taking Up Subfascial Endoscopic Perforator
Surgery for Patients of Lower Limb Varicose Veins with Below Knee Preforators:
Indian J Surg, Jun 2012
12. Niren Angle and Julie. A. Freischlag. Venous disease, ‘Sabiston Textbook of
surgery,” 17th Edition, 2005, pg 2053-2069.
13. Burkitt et al. “Varicose veins in India,” Lancet 1975; ii: 765-769.
16