RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE.

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|1. |NAME OF THE CANDIDATE AND ADDRESS |DR.BEERESH. C. S. |

| | |POSTGRADUATE STUDENT, |

| | |DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, |

| | |KARNATAKA INSTITUTE OF MEDICAL SCIENCES, |

| | |HUBLI- 580022. |

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|2. |NAME OF THE INSTITUTION |KARNATAKA INSTITUTE OF MEDICAL SCIENCES, |

| | |HUBLI -580022 |

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|3. |COURSE OF THE STUDY AND |M.S. IN OBSTETRICS AND GYNECOLOGY |

| |SUBJECT | |

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|4. |DATE OF ADMISSION TO THE COURSE |19-06-2009 |

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|5. |TITLE OF THE TOPIC |ASSESSMENT OF ENDOMETRIAL THICKNESS AND OVARIAN VOLUME BY ULTRASONOGRAPHY |

| | |IN POSTMENOPAUSAL WOMEN AT KIMS HUBLI. |

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|6. |BRIEF RESUME OF THE INTENDED WORK : |

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| |6.1 Need for the study |

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| |Menopause is permanent cessation of menses for one year and physiologically correlates with the decline in estrogen secretion |

| |resulting from the loss of follicular function. The size of ovaries and the endometrial thickness correlates with the ovarian |

| |activity and becomes atrophic after menopause. |

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| |Normal ovarian volume and endometrial thickness are of great importance as a criterion in the non invasive diagnosis of ovarian and |

| |endometrial malignancies. Any alteration in ovarian volume or endometrial thickness is of great concern as it points towards disease.|

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| |Endometrial cancer is a disease that occurs primarily in postmenopausal women and is increasingly virulent with advancing age and |

| |also the peak incidence of invasive ovarian cancer is at 56 to 60 years of age1. Finding of an endometrial thickness greater than 4mm|

| |requires further evaluation as it increases risk of malignancy1. Hence a cut off of 4mm is taken for histopathological examination |

| |(8, 9). |

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| |Hence, the purpose of our study is to assess and define the normal ovarian volume and endometrial thickness in menopausal women with |

| |ultrasonography and subject the patients with increased endometrial thickness (>4 mm) to histopathological examination. These base |

| |line values provide the data to obtain the sonographic diagnosis of abnormal ovarian size and endometrial thickness which may help in|

| |eventually establishing early diagnosis of malignancy. |

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| |Review of literature : |

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| |Lin3 et al (1991) and Levin4 et al (1995) examined 58 & 61 cases respectively who were self referred, asymptomatic, who were all over|

| |the age of 50 and they were all at least 1 year postmenopausal by clinical and historic criteria. Endovaginal ultrasound was used to |

| |measured endometrial thickness. The mean endometrial thickness was 5.2mm & 5.0 mm in Lin and Levin study respectively. |

| |Teppar R et al (1995) conducted prospective study to establish normal ovarian volume in postmenopausal woman by transvaginal |

| |ultrasonaography. Three dimensions of each ovary were measured and ovarian volume of every menopausal year was calculated. |

| |Curvilinear relationship was found between ovarian volume and menopausal age. Ovarian volume showed a progressive decrease from |

| |8.3cm3 in the first year post menopausal to 2.2cm3 after more than 15 years post menopausal.5 |

| |Warming et al (2002) examined the endometrial thickness in176 asymptomatic postmenopausal population by transvaginal ultrasound. They|

| |concluded that during the first 5 years after menopause (YSM) the mean ET was 2.3 mm but it decreased by 0.03 mm/year. From 5 to 13 |

| |YSM the ET remained stable at a mean of 1.8 mm with no significant changes. The normal range of the thickness of the postmenopausal |

| |endometrium in asymptomatic women varies with YSM.6 |

| |Adeeb et al (2007) studied 517 urban Malaysian disease free woman aged 45 years and above. Uterus intact, non HRT users were |

| |studied. This study presented normogram of ovarian volume and endometrial thickness derived from ultrasound assessment. The sample |

| |comprised 42% of postmenopausal woman with an average of 51 years. In this study early postmenopausal woman demonstrated endometrial |

| |thickness of less than 5mm eventually reaching 2mm in women more than 70 years. A cut off of less than 5mm was considered acceptable |

| |in normal post menopausal women. The mean right & left ovarian volume was 5.48 cm3 and 5.80cm3 respectively. There was a gradual |

| |decline in ovarian volume with age and menopausal from about 7cm3 at age 45-49 years to less than 1.5cm3 at 70years of age giving a |

| |clinical normal ovarian volume of less than 3.5cm3 in post menopausal women.7 |

| |A study conducted by Aruna N Kekre et all from CMC, Vellore, India (2008) compared the transvaginal sonographically-measured |

| |endometrial thickness with the histopathological diagnosis in postmenopausal women. Eighty postmenopausal women were studied |

| |prospectively. All of them underwent transvaginal sonography followed by either an office dilatation and curettage and/or a |

| |hysterectomy. Eight women had endometrial carcinoma and their mean endometrial thickness was 12.6±5 mm (mean ± SD). Taking 4 mm |

| |endometrial thickness as cut off the sensitivity of transvaginal scan to detect endometrial pathology was 97%, specificity 98%, |

| |positive predictive value 97% and negative predictive value 94%. Hence, they conclude that measurement of endometrial thickness by |

| |transvaginal scan is a good screening test in postmenopausal women for differentiating endometrial pathology from those who do not |

| |have an endometrial lesion and gave a simple message that postmenopausal women with an endometrial thickness of less than 4mm will |

| |not have endometrial cancer.8 |

| |Steven R et al (2009) conducted large prospective study on American post menopausal woman and concluded that endometrial thickness |

| |less than 4mm on trans vaginal ultra sonography in postmenopausal woman with bleeding as a risk of endometrial cancer of only 1in |

| |917. Thus in post menopausal patient biopsy is not indicated when endometrial thickness is less than 4mm. |

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| |6.3. Objectives of the study : |

| |To study the ovarian volume and endometrial thickness by ultrasonography in postmenopausal women to define base line parameters. |

| |To subject individuals with abnormal endometrial thickness (more than 4mm) to histopathologic examination. |

| |To correlate abnormal endometrial thickness with histopathology. |

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|7. |MATERIALS AND METHODS |

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| |Source of Data : |

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| |Post menopausal women attending the out patient and in patients cases in OBG Dept of KIMS Hubli from Dec 2009 to Nov 2010. |

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| |7.2 INCLUSION CRITERIA: |

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| |Healthy naturally achieved post menopausal women of age more than 40 years. |

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| |EXCLUSION CRITERIA: |

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| |Subject with premature menopause. |

| |Subject with obvious mass or infiltration of ovaries. |

| |Patients receiving pelvic irradiation, chemotherapy, hysterectomised individual or other conditions know to cause atrophy of ovaries.|

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| |Patient with endometrial cancer. |

| |Subjects on hormone replacement therapy. |

| |Patients taking Tamoxifen therapy. |

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| |7.3 METHODS OF COLLECTION OF DATA: |

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| |A predesigned Proforma is used for all cases. Detailed history, clinical examination, necessary investigations including |

| |ultrasonography, dilatation and curettage for histopathology is done following a written consent. |

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| |Ovarian volume calculated by transvaginal ultrasonography using 5-7.5MHz probe. |

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| |Ovarian volume calculated by ellipsoidal formula. |

| |Ovarian volume=0.523 x length x width x Thickness.2 |

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| |Endometrial thickness assessed from sagittal image through the body and fundus of the uterus, the thickest portion of the endometrium|

| |was measured between the boundaries separating the hyper echoic endometrium from the adjacent layer of myometrium. The double |

| |thickness was measured in each case .2 |

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| |SAMPLE SIZE |

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| |As it is a time bound study all cases of Postmenopausal women fulfilling the inclusion and exclusion criteria coming during the study|

| |period (DEC 2009 to NOV 2010) will be taken for study. |

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| |Does the study require any investigations or interventions to be conducted on patients, humans or animals? If so, please describe |

| |briefly. |

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| |Yes. |

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| |These investigations will be required: |

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| |Ultrasound examination of all cases |

| |Dilatation and curettage followed by histopathology if required. |

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| |7.5 Has ethical clearance has been obtained from your institution in case of 7.4 |

| |Yes, clearance has been obtained from the Ethical Committee of Karnataka |

| |Institute of Medical Sciences, Hubli. |

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| |7.6 Statistical analysis: |

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| |Results will be analyzed by using appropriate statistical tests. |

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|8. |LIST OF REFERENCES: |

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| |Jonathan S Berek. Berek and Novak’s Gynecology, 14th edn. Lippincott Williams and Wilkins; 1343-1401, 1457-1547. |

| |Keals TE, Sistrom C. Atlas of Radiologic Measurement 17th edn. St Louis Mosby, 2001. |

| |Lin MC, Gosink BB, Wolf SI, etal. Endometrial thickness after menopause; Effect of Hormone replacement. Radiology 1991; 180(2): |

| |427-432. |

| |Levin D, Gosink BB, Johnson CA. change in endometrial thickness in Postmenopausal women undergoing hormonal replacement therapy. |

| |Radiology 1995; 197: 603-608. |

| |Tepper R, Zalel, Markov. Ovarian volume in Postmenopausal women- Suggestion for an ovarian normogram for Postmenopausal age. Acta |

| |obstetrica et Gynecologica Scandinavica 1995; 74:208-211. |

| |Warming L, Ravn P, Skouby S, Christiansen C. Measurement Precision and normal range of endometrial thickness in a postmenopausal |

| |population by transvaginal ultrasound. Journal of ultrasound in obstetrics and Gynecology 2002, 20(5):492-495 |

| |Adeeb N, Nur-Azurah AG, etal; Normogram of ovarian volume, uterine size and endometrial thickness in urban Midlife Malaysian Women. |

| |Journal of Medicine and Health 2007;2(1); 66-79. |

| |Aruna N. Kekre Ruby Jose, Lakshmi Seshadri; Dept of OBG, CMC, Vellore, India; Transvaginal sonography of the endometrium in South |

| |Indian Postmenopausal women Australian and New Zealand Journal of Obstetrics and Gynecology Feb 2008; 37(4): 449-451. |

| |Steven R Goldstein. The role of transvaginal ultrasound or endometrial biopsy in the evaluation of the menopausal endometrium. |

| |American Journal of Obstetrics and Gynecology 2009; 5-11. |

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|9. |SIGNATURE OF THE CANDIDATE | |

| | |THIS STUDY IS RECOMMENED AS IT DEFINES NORMAL OVARIAN AND ENDOMETRIAL |

|10. |REMARKS OF THE GUIDE |PARAMETERS IN POSTMENOPAUSAL WOMEN AND HELPS IN EARLY DETECTION OF |

| | |MALIGNANCIES. |

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|11. |11.1 NAME AND DESIGNATION OF |Dr. kasturi donimath md (obg) |

| |THE GUIDE |PROFESSOR |

| | |DEPARTMENT OF obstetrics and gynecology |

| | |KIMS, HUBLI. |

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| |11.2 SIGNATURE | |

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| |11.3 CO-GUIDE (IF ANY) |DR G.C. PATIL MD (RD) |

| | |PROFESSOR AND HEAD |

| | |DEPARTMENT OF RADIOLOGY |

| | |KIMS, HUBLI. |

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| |11.4 SIGNATURE | |

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| |11.5 HEAD OF THE DEPARTMENT |Dr. U.S. HANGARGA md (obg) |

| | |PROFESSOR & HEAD, |

| | |DEPARTMENT OF obstetrics and gynecology |

| | |KIMS, HUBLI. |

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| |11.6 SIGNATURE | |

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|12 |12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL | |

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| |12.2 SIGNATURE. | |

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From: Date:

Dr. BEERESH.C.S

Post Graduate student

Department of OBG

KIMS, Hubli

To,

The Principal

KIMS, Hubli.

Sub: Forwarding of synopsis of Dissertation topic to the

Rajiv Gandhi University of Health Sciences,

Bangalore for registration.

Through proper channel

Respected Sir,

With reference to the above subject here in I submit my synopsis for the registration of dissertation topic that is “ASSESMENT OF ENDOMETRIAL THICKNESS AND OVARIAN VOLUME BY ULTRASONOGRAPHY IN POSTMENOPAUSAL WOMEN AT KIMS HUBLI.”. Hence I request your kind self to forward the same to the Rajiv Gandhi University of Health Sciences, Bangalore, for registration and do the needful

Thanking you,

Yours Faithfully,

DR. BEERESH.C.S

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