Rajiv gandhi university of health sciences, bengaluru, karnataka



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BENGALURU, KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.



Name of the candidate and address


DR.VEENA ANDANAPPANAVAR

Room No:308

Vishranthi Dhama

Victoria Hospital Campus

BANGALORE-560002


2.



Name of the institution

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE


3.



Course of study and subject

M.D. DERMATOLOGY,

VENEREOLOGY AND LEPROSY

4.



Date of admission to the course

27/05/2013



5.


Title of the topic

Clinico-epidemiological study of Cutaneous manifestations in Polycystic Ovary Syndrome patients


6. Brief resume of the intended work:

6.1 Need for the study:

Polycystic ovary syndrome (PCOS) is one of the most frequently encountered endocrine disorders occurring in women of reproductive age. It has been found that, this condition occurs in as many as 4 to 10% of women of reproductive age.1 Menstrual irregularities, infertility and hirsutism are the common symptoms in these patients. If not treated appropriately, the patients are at risk for type 2 diabetes mellitus, cardiovascular disease and hyperestrogen related cancers. The hallmark of endocrine disorders of this syndrome is hyperandrogenism and hyperinsulinemia1.

Polycystic ovary syndrome is a true syndrome, being a heterogeneous collection of signs and symptoms that gathered together form a spectrum of disorder with mild presentation in some, to severe disturbance of reproductive, endocrine and metabolic function in others2.

Well recognized cutaneous manifestations include hirsutism, acne, androgen dependent alopecia and acanthosis nigricans 3, 4, 5. These could form important clinical markers for early diagnosis of this condition which helps in proper management.

Hence, the aim of our study is to determine the prevalence of cutaneous manifestations and frequency of different cutaneous manifestations in different age groups of PCOS patients.

6.2 Review of literature:

By using Rotterdam’s criteria, the syndrome is diagnosed by the presence of any two of the following three criteria:1. Oligo/Anovulation 2. Clinical and/or biochemical features of hyperandrogenism 3. Polycystic ovaries on USG, after excluding other causes 6.

Polycystic ovary syndrome is a multispeciality disorder suspected in patients with irregular menses, acne, hirsutism, androgenic alopecia, seborrrheoa and acanthosis nigricans 7.

Obese polycystic ovary syndrome patients may also present with multiple skin tags in frictional areas like neck, axillae, groin folds, inframammary area, and even under the pendulous abdominal folds7.

Polycystic ovary syndrome patients may also present with seborrhea. It is a common disorder among women with inflammatory acne which is minimally responsive to conventional line of treatment. A premenstrual flare is common in these patients 7,8.

In a study conducted by Daisy Kopera et al it has been shown that the hirsutism represents a primary clinical indicator of androgen excess. The most common endocrine condition causing hirsutism (> 70% of cases) is polycystic ovary syndrome. The prevalence of hirsutism in PCOS patients is 40 to 92% in European and American females and even more common in darker skin types 9.

Women with early onset female pattern hair loss are much more likely to have associated hyperandrogenism. Most women who present with androgenic alopecia as their primary complaint also have polycystic ovaries (67% of cases) and have indices of abnormal androgen production 7,10.

In a study conducted by Sunitha J Ramanand et al, it has been showed that the prevalence of acanthosis nigricans and hirsutism are comparable in Indian polycystic ovary syndrome patients patients 11.



6.3 Objectives of the study:

1. To determine the prevalence of cutaneous manifestations in PCOS patients

2. To determine the frequency of various cutaneous manifestations in different age groups

3. To correlate cutaneous manifestations with the degree of hormonal abnormalities


7. MATERIALS AND METHODS:
7.1 Sources of data:

Patients attending dermatology out patient department (Victoria hospital and Bowring and Lady Curzon hospital) with cutaneous manifestations suggestive of PCOS and confirmed PCOS patients referred from Department of OBG (Vanivilas hospital and Bowring and Lady Curzon hospital) to Department of Dermatology, both departments being attached to Bangalore Medical College and Research Institute.



7.2 Methods of collection of data:

A. Study design: A cross sectional descriptive study

B. Place of study: Dermatology outpatient department at Victoria Hospital and Bowring and Lady Curzon Hospital

C. Study sample size: 50 patients

D. Study period: November 2013 – September 2015

E. Method of sampling: Random sampling
E. Inclusion criteria:

1. All PCOS patients attending Dermatology and Gynaecology outpatient departments with manifestations suggestive of PCOS

2. Menarche to menopause

3. Those willing to participate after taking written informed consent.


F. Exclusion criteria:

1. Pregnant women

2. Those who don’t consent for participation.
G. Methodology for data collection: Data collection will be started after clearance from Ethics Committee. Patients with features of PCOS attending Dermatology department and Gynaecology department will be screened. A detailed history of patients with regard to name, age, nature and duration of illness, family history, any associated symptoms and any investigations done previously for the diagnosis of PCOS will be taken. To diagnose PCOS in our study, patients pelvic ultrasonography will be done and blood sample will be sent for random blood sugar (RBS) and hormonal assay for free testosterone, dehydroepiandrosterone (DHEAs), LH:FSH (Leutinising Hormone and Follicle Stimulating Hormone) ratio and thyroid profile. Diagnosis of PCOS will be done using Rotterdam’s criteria. Diagnosed patients will be reviewed again for the presence of cutaneous manifestations.

H. Methodology for data analysis:

Data will be analyzed using descriptive statistics. SPSS statistical software will be utilized for analysis.



7.3 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so please describe briefly.
The following investigations will be advised to patients for diagnosing PCOS.

  1. Pelvic ultrasonography

  2. RBS and hormonal assay to look for free testosterone, DHEAs, LH, FSH,

thyroid profile.
This study does not require any animal experimentation and/or human intervention.

7.4 Has ethical clearance has been obtained from your institution in case of 7.2?

YES



8.List of references :


  1. Keri Marshall, ND Candidate 2001. Polycystic ovary syndrome: Clinical considerations. Alternative Medicine Review 2001;6(3): 272-292.

  2. Adem B, Kathy M. What is polycystic ovary syndrome?. Oxford journals medicine human reproduction 2002; 17(9): 2219-2227.

  3. Ricardo A, Kelie SW, Rosario R, Timothy JK, Eric SK, Bulent OY. The prevalence and features of the polycystic ovary syndrome in an unselected population: A prospective study done at University of Alabama at Birmingham. Journal of Clinical Endocrinology and metabolism 2004;89(6): 2745-2749.

  4. Marta BRF, Ana GP, Tamara BLG, Jose E, Anagloria B. Clinical manifestations, biochemical, metabolic and ultrasonographic study of polycystic ovary syndrome in adolescents. Brazilian Journal of Gynaecology and Obstetrics 2013; 35(6).

  5. Melissa HH, Peter JC. Evaluation and treatment of women with hirsutism. Am Fam Physician 2003;67(12): 2565-2572.

  6. Rotterdam ESHRE/ASRM-sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic and long term health risks related to polycystic ovary syndrome. Hum repro 2004;19:41-7.

  7. Nina M, Kaleem K, Phelrenu C, Girish P. Polycystic ovary syndrome. Indian J Dermatol Venereol Leprol 2013;79(3):310-321.

  8. Soodabeh Z, Saeideh F, Hamideh S. Prevalence of polycystic ovary syndrome in women with acne: Hormone profiles and clinical findings. Journal of Pakistan Association of Dermatologists 2010;20:194-198.

  9. Daisy K, Elisabeth W, Barbara OP. Endocrinology of hirsutism. International Journal of Trichology. 2010;2(1):30-35.

  10. Ester C, Carole R, Karon R, Eleni K, Davinia MW, Helen W et al. Prevalence of polycystic ovaries in women with androgenic alopecia. Europian Journal of Endocrinology 2003;149:439-442.

  11. Sunita JR, Balasaheb BG, Jaiprakash BR, Milind HP, Ravi RG, Suyog SJ. Clinical characteristics of polycystic ovary syndrome in Indian women. Indian Journal of Endocrinology and metabolism. 2013;17(1):138-145



9.




Signature of the candidate


10.



Remarks of the Guide

Although the cutaneous manifestations of androgen excess seen in PCOS patients is well recognized, there is surprisingly paucity of data on the prevalence of each cutaneous manifestation in PCOS patients.

Hence this study may be helpful to find out cutaneous manifestations as marker of underlying condition of androgen excess seen in PCOS patients and to study the manifestations in relation with degree of abnormal lab findings.



11.1


11.2


Name and designation of Guide


Signature


DR.REVATHI T.N.

ASSISTANT PROFESSOR

DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE





11.3


11.4


Name and designation of Co-guide

Signature

DR.MALINI K.V.

PROFESSOR AND HEAD OF THE DEPARTMENT

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE


11.5

11.6




Head of the Department

Signature

DR. SACCHIDANAND S

PROFESSOR AND HEAD OF THE DEPARTMENT

DERMATOLOGY, VENEREOLOGY AND LEPROSY

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,


12.1


12.2




Remarks of the,

Director cum Dean

Signature



CONSENT FOR PHOTOGRAPHY


I ______________aged _______ have been explained about the purpose of photographs which will be taken. I have also been explained that, the identity of my photographs will not be revealed to any third party. These photographs, along with the information which I have provided, may be used for publications in Journals, textbooks, articles and other academic purposes.

After understanding afore mentioned things, I am giving my full valid consent for photography.


Date:
Doctors signature Patients/Guardians SIgnature





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