1



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES.

KARNATAKA, BANGALORE.

ANNEXURE-2

PROFORMA FOR REGISTRATION OF TOPIC FOR DISSERTATION.

|1. |Name of the Candidate and Address. |Dr.Padmashri.V.P.Reddy |

| | |#1142, 35TH C Cross, 26th A Main, 4th T Block, Jayanagar, Bangalore-41. |

|2. |Name of the Institution. |Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bangalore. |

|3. |Course of Study and Subject. |M.S. OBG. |

|4. |Date of Admission to the course. |31st May, 2009. |

|5. |Title of the Topic. |Endometrial Study in Postmenopausal Women Conducted at Kempegowda Institute of Medical |

| | |Sciences Hospital and Research Centre. |

| | | |

6.1 Need for the Study.

- Trans-vaginal ultrasound examination for measurement of endometrial thickness is a very sensitive and non invasive procedure that is used to select postmenopausal women for dilatation & curettage & other endometrial sampling methods because the frequency of endometrial pathology increases with increasing endometrial thickness.

- Women with thick endometrium (>/=4mm) are at high risk of endometrial pathology, a reliable diagnostic method is mandatory.

6.2 Review of Literature:

JOURNALS:

1. Ben-Baruch G, Seidman DS, Schiff E, Moran O, Menczer J. Outpatient endometrial sampling with the Pipelle curette. Gynecol Obstet Invest. 1994;37(4):260-2-Endometrial sampling with the pipelle was well tolerated causing occasionally only slight discomfort with sufficient material for histological assessment.

2. Guido RS. Pipelle endometrial sampling. Sensitivity in the detection of endometrial cancer. J Reprod Med - 01-AUG-1995; 40(8): 553-5.-Study done on 65 patients malignancy was detected by biopsy in 54 of 65, for a sensitivity of 83+/-5%.The Pipelle endometrial suction curette is an effective office device for evaluating patients at risk of endometrial cancer, however, tumours localized to a polyp or small area of endometrium may go undetected.

3. Haller H, Matecjcić N, Rukavina B, Krasević M, Rupcić S, Mozetic D. Trans-vaginal sonography and hysteroscopy in women with postmenopausal bleedingInt J Gynaecol Obstet. 1996 Aug;54(2):155-9.-Prospective comparative study between endometrial thickness determined by trans-vaginal sonography and hysteroscopic findings in women with postmenopausal bleeding with histologic findings obtained by D&S and Hysteroscopy are complementary diagnostic methods and could be accurately used to discriminate normal and pathologic conditions in patients with postmenopausal bleeding.

4. Giusa-Chiferi MG, Gonçalves WJ, Baracat EC, de Albuquerque Neto LC, Bortoletto CC, de Lima GRTrans-vaginal ultrasound, uterine biopsy and hysteroscopy for postmenopausal bleeding.. Int J Gynaecol Obstet. 1996 Oct;55(1):39-44-When the thickness of endometria; echo is less than 3mm there is no need for anatomopathologic investigation. When this limit was adopted, all cases were associated with endometrial atrophy, and when the limit was 4mm or more, active endometria were detected, requiring further histopathologic investigation by hysteroscopy and directed biopsy.Above 8mm, malignancy may be found.

5. Mortakis AE, Mavrelos K. Trans-vaginal ultrasonography and hysteroscopy in the diagnosis of endometrial abnormalities. J Am Assoc Gynecol Laparosc. 1997 Aug;4(4):449-52.-Prospective non randomized study to investigate the value of trans-vaginal ultrasonography, aspiration biopsy and hysteroscopy combined with curettage in detecting endometrial pathology.CONCLUSION-Trans-vaginal ultrasound is an excellent initial diagnostic method, with high sensitivity in diagnosing endometrial abnormalities.Its combination with aspiration biopsy seems to be safe in women with thin endometrium.Hysteroscopy is necessary in postmenopausal women with an endometrium of >/=4mm.

6. Loizzi V, Bettocchi S, Vimercati A, Ceci O, Rossi C, Marello F, Greco P. Hysteroscopic evaluation of menopausal women with endometrial thickness of 4 mm or more. J Am Assoc Gynecol Laparosc. 2000 May;7(2):191-5-Hysteroscopy with endometrial biopsy samples has a diagnostic and operative role in postmenopausal patients selected based on endometrial thickness on ultrasound, in view of the high prevalence of endometrial pathology in both symptomatic and asymptomatic women.

7. Elsandabesee D, Greenwood P. The performance of Pipelle endometrial sampling in a postmenopausal bleeding clinic. J Obstet Gynaecol. 2005 Jan;25(1):32-4-Study done on 97 patients recommends this procedure for women with endometrial thickness >/=4mm, little can be gained from endometrial sampling as malignancy is rare and the chance of getting an adequate sample is small when the endometrial thickness is /=4mm.Hysteroscopy shows great efficiency in diagnosing focal abnormalities of the endometrium.

9. Schmidt T, Breidenbach M, Nawroth F, Mallmann P, Beyer IM, Fleisch MC, Rein DT. Hysteroscopy for asymptomatic postmenopausal women with sonographically thickened endometrium. Maturitas. 2009 Feb 20;62(2):176-8. Epub 2009 Jan 3.-A prospective observational study conducted on 304 postmenopausal women. Conclusion-Hysteroscopy represents an easy, safe and effective method for the investigation of asymptomatic women with thickened endometrium found on TVS.

TEXTBOOK:

1.Postmenopausal bleeding or discharge calls for immediate investigation even thought there is only a single episode. Trans-vaginal ultrasound, endometrial biopsy and hysteroscopy are necessary-JEFFCOATE’S PRINCIPLES OF GYNAECOLOGY.

6.3 Objectives:

- To evaluate endometrial pathology in postmenopausal women with endometrial thickness >4mm on trans-vaginal ultrasound.

- To evaluate the efficacy of pipelle aspiration biopsy and hysteroscopy guided biopsy in women with endometrial thickness >4mm by trans-vaginal scan.

7 Materials and Methods:

7.1 Source of Data:

All Postmenopausal Women attending Gyneacology OPD in Department of Obstetrics and Gynaecology KIMS Hospital, Bangalore.

Study design -Descriptive study.

Sample size -100

Sample design - Purposive sampling

Study place -Department of Obstetrics and Gynaecology, KIMS Hospital Bangalore.

Study period -November 2009 to March 2011

7.2 Method of collection of data:

- All Postmenopausal Women whether symptomatic or asymptomatic who fulfill the inclusion and exclusion criteria and are willing to participate in the study will be selected on the basis of purposive sampling.

- A detailed history will be taken. Systemic examination & routine Pap smear will be done.

- Informed & written consent of all cases for routine trans-vaginal sonogram will be taken after explaining the procedure.

- All patients will initially undergo trans-abdominal ultrasound followed by trans-vaginal sonogram.

- Patients with endometrial thickness >/=4mm will be subjected to office pipelle biopsy and diagnostic hysteroscopy directed fractional curettage.

Statistical Analysis:

The data collected in the study will be analysed statistically using descriptive statistics like Percentage, Mean and standard deviation.

7.3 Inclusion Criteria:

1.Women who reported a period of atleast 12 months of amenorrhoea after the age of 40 yrs provided that the amenorrhoea was not explained by medication or disease.

2.All postmenopausal women whether symptomatic or asymptomatic having endometrial thickness >/=4mm.

7.4 Exclusion Criteria:

1.Women with bleeding diathesis and cardiac diseases.

2.Women with abnormal Pap Smear report/ grossly abnormal cervix.

3.Women with diagnosed genital tract malignancy.

7.5 Does the study require any investigation or intervention to be conducted on patients or other humans or animals If so, describe briefly:

1.Routine preoperative investigations.

2.Trans-abdominal & Trans-vaginal ultrasonography.

3.Pap Smear.

4.Pipelle Biopsy.

5.Diagnostic Hysteroscopy.

7.6 Has ethical clearance been obtained from your institution for this study and required investigations in this study:

YES.

8. References.

JOURNALS:

1. Ben-Baruch G, Seidman DS, Schiff E, Moran O, Menczer J. Outpatient endometrial sampling with the Pipelle curette. Gynecol Obstet Invest. 1994;37(4):260-2

2. Guido RS. Pipelle endometrial sampling. Sensitivity in the detection of endometrial cancer. J Reprod Med - 01-AUG-1995; 40(8): 553-5.

3. Haller H, Matecjcić N, Rukavina B, Krasević M, Rupcić S, Mozetic D. Trans-vaginal sonography and hysteroscopy in women with postmenopausal bleedingInt J Gynaecol Obstet. 1996 Aug;54(2):155-9.

4. Giusa-Chiferi MG, Gonçalves WJ, Baracat EC, de Albuquerque Neto LC, Bortoletto CC, de Lima GRTrans-vaginal ultrasound, uterine biopsy and hysteroscopy for postmenopausal bleeding.. Int J Gynaecol Obstet. 1996 Oct;55(1):39-44.

5. Mortakis AE, Mavrelos K. Trans-vaginal ultrasonography and hysteroscopy in the diagnosis of endometrial abnormalities. J Am Assoc Gynecol Laparosc. 1997 Aug;4(4):449-52.

6. Loizzi V, Bettocchi S, Vimercati A, Ceci O, Rossi C, Marello F, Greco P. Hysteroscopic evaluation of menopausal women with endometrial thickness of 4 mm or more. J Am Assoc Gynecol Laparosc. 2000 May;7(2):191-5

7. Elsandabesee D, Greenwood P. The performance of Pipelle endometrial sampling in a dedicated postmenopausal bleeding clinic. J Obstet Gynaecol. 2005 Jan;25(1):32-4

8. Tinelli R, Tinelli FG, Cicinelli E, Malvasi A, Tinelli A. The role of hysteroscopy with eye-directed biopsy in postmenopausal women with uterine bleeding and endometrial atrophy.

Menopause. 2008 Jul-Aug;15(4 Pt 1):737-42

9. Schmidt T, Breidenbach M, Nawroth F, Mallmann P, Beyer IM, Fleisch MC, Rein DT. Hysteroscopy for asymptomatic postmenopausal women with sonographically thickened endometrium. Maturitas. 2009 Feb 20;62(2):176-8. Epub 2009 Jan 3.

TEXTBOOK:

1. JEFFCOATE’S PRINCIPLES OF GYNAECOLOGY.

9. Signature of Candidate:

10. Remarks of the Guide:

-Evaluation of postmenopausal bleeding is a difficult situation where array of tests are required to diagnose genital malignancy at early stages.

-This study will help us to evaluate the effective modality of diagnosing endometrial pathology in postmenopausal bleeding.

11. Name and Designation of:

|11.1 |Guide |Dr.SUDHA.C.P MD |

| | |Associate Professor, |

| | |Department of OBG, |

| | |KIMS,Bangalore. |

|11.2 |Signature |  |

|11.3 |Co-Guide |Dr.SRINIVASA BABU.C.R |

| | |Professor and HOD, |

| | |Department of Radio Diagnosis |

| | |KIMS, Bangalore |

| | | |

| | |  |

|11.4 |Signature |  |

|11.5 |Head of Department |Dr. B. C. NAIK. MD, DGO |

| | |Professor and HOD, |

| | |Department of OBG, |

| | |KIMS,Bangalore. |

|11.6 |Signature |  |

|12.1 |Remarks of the chairman and |  |

| |principal | |

| | | |

| | | |

| | | |

| | | |

| | | |

| | | |

|12.2 |Signature | |

| | | |

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| | |  |

PROFORMA

CASE NO: IP NO:

NAME: DOA:

AGE: DOD:

SPOUSE NAME:

ADDRESS:

OCCUAPTION: Patient-

Husband-

SOCIO ECONOMIC STATUTS:

PRESENTING COMPLAINTS:

HISTORY OF PRESENTING COMPLAINTS:

MENSTRUAL HISTORY: AOM- MENOPAUSE ATTAINED YR/YRS BACK.

PAST MENSTRUAL CYCLES- REGULAR/IRREGULAR.

CLOTS - DYSMENORRHOEA-

OBSTETRIC HISTORY:

MARRIED LIFE- OBSTETRIC SCORE-

TUBECTOMIZED-

|NO |MODE OF DELIVERY |BT WT |SEX |ANY COMPLICATIONS |

| | | | | |

DRUG HUSTORY:

PAST MEDICAL HISTORY: HISTORY OF DIABETES MILLITIS-

HYPERTENSION- ASTHMA- IHD-

TUBERCULOSIS- EPILEPSY- MALIGNANCY-

ANY OTHER-

PAST SURGICAL HISTORY:GENERAL-

GYNAECOLOGICAL-

FAMILY HISTORY:HISTORY OF DIABETES MILLITIS-

HYPERTENSION- ASTHMA- IHD-

TUBERCULOSIS- EPILEPSY- MALIGNANCY-

SURGERY-

ANY OTHER-

PERSONAL HISTORY:

DIET- APPETITE- SLEEP-

BOWEL HABITS- BLADDER HABITS-

SMOKING/DRINKING/OTHER HABITS-

GENERAL PHYSICAL EXAMINATION-A yr Old female patient built and nourished conscious cooperative and well oriented with time,place and person.

Pulse: bpm BP: mmHg

HT: cms WT: kgs BMI-

BREAST- SPINE- THROID-

SYSTEMIC EXAMINATION:

CVS:

RS:

CNS:

PA:

PS:

PV:

INVESTIGATIONS-

HB- g/dl PCV- % TC- cells/cumm

DC- N L E M B ESR- mm/hr PLT COUNT- lakhs/cumm

BT- min sec CT- min sec

BLOOD GROUPIANG AND TYPING-

URINE ROUTINE-Albulmin-

Sugar-

Pus cells

Epithelial cells-

FBS- mg/dl PPBS- mg/dl

HIV- HBsAG- VDRL-

THYROID PROFILE: T3- T4- TSH-

RENAL FUNCTION TESTS:B.Urea- mg/dl

S.Creatinine- mg/dl

OTHERS-

CHEST X-RAY-

ECG-

PAP SMEAR-

ULTRASONOGRAPHY: TAS&TVS-

HISTOPATHOLOGY:

PIPELLE BIOPSY-

HYSTEROSCOPY DIRECTED BIOPSY-

DIAGNOSIS-

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