RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the candidate and address (in block |Dr. SUCHITHRA.R |

| |letters) |VYDHEHI INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTRE |

| | |#82 EPIP AREA, NALLURAHALLI, |

| | |WHITEFIELD, BANGALORE, - 560066 |

|2 |Name of the Institution |Vydehi Institute of Medical Sciences & Research Centre. |

| | | |

|3 |Course of the study and subject |M.S. OBSTETRICS AND GYNAECOLOGY |

| | |(3 YEARS DURATION) |

|4 |Date of admission to course |05/06/2013 |

|5 |Title of the topic |

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| | |

| |Comparative study of the diagnostic accuracy of transvaginal sonography versus hysteroscopy in abnormal |

| |uterine bleeding |

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|6 |Brief resume of the intended work |

|6.1 |Need for the study |

| |Abnormal uterine bleeding (AUB) is a common gynecologic complaint in women attending outpatient department.|

| |The causes may vary from simple dysfunctional uterine bleeding without any organic cause to the endometrial|

| |cancer. The cases of AUB usually need thorough investigation to rule out organic causes especially at |

| |perimenopausal and postmenopausal age when the risk of endometrial carcinoma is 10% to 15%. |

| | |

| |Hysteroscopy : |

| |Hysteroscopy permits direct visualisation of the cervical canal and uterine cavity, enabling observation of|

| |intrauterine abnormalities through a rigid, flexible or contact hysteroscope . |

| | |

| | |

| |Transvaginal ultra sonography: ultrasound imaging of female pelvis using an endoscopic probe placed in the |

| |vagina. Transvaginal sonography (TVS) plays an important role as the initial modality for evaluation of |

| |AUB. |

| | |

| |To compare the diagnostic efficacy of transvaginal ultrasonography with hysteroscopy in abnormal uterine |

| |bleeding. |

| | |

| |Role of TVS / hysteroscopy in management protocol of abnormal uterine bleeding. |

| | |

|6.2 |Review of literature: |

| |1) A comparision between ultrasonography and hysteroscopy in diagnosis of uterine pathology |

| |OBJECTIVE: To evaluate the diagnostic accuracy of transvaginal sonograohy (tvs)compared to hysteroscopy|

| |in diagnosing uterine abnormalities. In addition, to determine whether the number of diagnostic |

| |hysteroscopies can be reduced and replaced by tvs examinations. |

| | |

| |Study design: retrospective study, data from 128 patients were summarized who underwent tvs examination and|

| |hysteroscopy during last two years. Specimens were obtained and sent for histopathological examination. |

| |Sensitivity , specificity, positive and negative predictive values for diagnosing uterine pathology were |

| |calculated for each method. |

| |BY: Dana vitner,shlcmofilmer,Israel Goldstein,nizar khatib,zeev weiner IN 2013. |

| |RESULTS: |

| |Hysteroscopy had a significantly higher sensitivity in diagnosing intra-uterine fibroids while tvs had a |

| |significantly higher sensitivity in diagnosing retained products of conception. Although hysteroscopy had |

| |better predictive values for diagnosing uterine polyps the difference was not statistically significant. |

| |CONCLUSION: |

| |TVS is an excellent tool in evaluating retained products of conception in other cases of uterine |

| |pathology,diagnosis with hysteroscopy is needed to improve diagnostic accuracy |

| | |

| |2) Comparative study of transvaginal sonography and hysteroscopy for the detection of pathological |

| |endometrial lesions in women with perimenopausal bleeding |

| |Top of Form |

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| |Bottom of Form |

| |Objective |

| |To estimate the diagnostic accuracy of two dimensional transvaginal ultrasound and hysteroscopy compared |

| |with histopathology in evaluation of uterine cavity lesions in perimenopausal women with abnormal uterine |

| |bleeding. |

| |Design |

| |Descriptive diagnostic trial. |

| |Setting |

| |Cairo University Hospital. BY Waleed El-khayat, Mohamed Ehab Sleet, Enas Yassen Mahdi in 2011 |

| | |

| |Materials and methods |

| |A total of 50 patients with perimenopausal bleeding scheduled for 2D TVS, hysteroscopy and histopathologic |

| |examination of tissue specimen. |

| |Results: |

| |The commonest bleeding pattern was menorrhagia (40%) followed by menometrorrhagia in 34%, endometrial |

| |hyperplasia was found in about half of these lesions and was associated with endometrial polyp in half of |

| |the multiple lesions, endometrial hyperplasia was the most frequent finding by TVS (32%) with a mean |

| |endometrial thickness of 11.2[pic]±[pic]2.4[pic]mm followed by endometrial polyp (26%) with a mean |

| |endometrial thickness of 18.0[pic]±[pic]5.3[pic]mm. Using hysteroscopy the commonest lesion diagnosed was |

| |endometrial polyp which was found in 28% of cases, while endometrial hyperplasia found only in 20%. 2D |

| |ultrasound shows good sensitivity in detection of endometrial polyp, highest specificity and accuracy was |

| |for adenomyosis. Hysteroscopy was poorly sensitive but highly specific for both endometrial hyperplasia and|

| |adenomyosis. For endometrial polyp hysteroscopy was highly sensitive, specific and accurate. Ultrasound was|

| |more sensitive and more accurate than hysteroscopy for detection of uterine lesions but hysteroscopy show |

| |higher specificity. |

| |Conclusion: |

| |For differentiating normal from abnormal endometrial cavity both 2D TVS and hysteroscopy show high accuracy|

| |but U/S was more sensitive and a little more accurate than hysteroscopy while the hysteroscopy was more |

| |specific. |

| |3) Comparison of transvaginal sonography, saline infusion sonography, and office hysteroscopy in |

| |reproductive-aged women with or without abnormal uterine bleeding |

| |SefaKelekci, M.D.ErdalKaya, M.D., Murat Alan, M.D., Yasemin Alan, M.D., Umit Bilge, M.D.,Leyla |

| |Mollamahmutoglu, M.D. in 2006 |

| |Objective: |

| |To compare the diagnostic accuracy and acceptability of transvaginal sonography (TVS), saline infusion |

| |sonography (SIS), and office hysteroscopy (OHS) for detecting intracavitary abnormalities in women with or |

| |without abnormal uterine bleeding (AUB). |

| |Design |

| |Prospective double-blind study. |

| |Setting |

| |Zekai Tahir Burak Women’s Health Education and Research Hospital, Gynecology Clinic (Ankara, Turkey). |

| |Patient(s): |

| |A total of 26 women with AUB and 24 women without AUB were enrolled in this study. |

| |Intervention(s): |

| |Transvaginal sonography, SIS, and OHS were performed on women scheduled for hysterectomy. |

| |Main Outcome Measure(s): |

| |Sensitivity, specificity, and positive and negative predictive values of TVS, SIS, and OHS to detect |

| |intracavitary abnormalities (with histopathologic findings used as the gold standard), duration of |

| |procedure, and pain scores. |

| |Result(s): |

| |The sensitivity and specificity of TVS, SIS, and OHS in detecting intracavitary abnormalities were 56.3% |

| |and 72%, 81.3% and 100%, and 87.5% and 100%, respectively. The prevalence of endometrial polyps was not |

| |different in women with and without AUB. Saline infusion sonography was less painful than OHS (pain scores |

| |of 4.3 and 7.2, respectively). |

| |Conclusion(s): |

| |The diagnostic accuracy of SIS was equal to that of OHS in diagnosing intracavitary abnormalities. |

| |Moreover, SIS was less painful than OHS for patients. |

| |4) Comparison of Office Hysteroscopy, Transvaginal Ultrasonography and Endometrial Biopsy in Evaluation of |

| |Abnormal Uterine Bleeding |

| |Lubna Pal, MD, L. Lapensee, MD, T.L. Toth MD, and K.B. Isaacson MD (1997) |

| | |

| |Objective: |

| |A comparison between office hysteroscopy, transvaginal ultrasonography and endometrial biopsy was |

| |performed, in terms of detection of intrauterine lesions. A secondary objective was assessment of |

| |evaluatory approach in the management of abnormal uterine bleeding in an outpatient setting. |

| |Design: |

| |Prospective observational study. |

| |Material and Methods: |

| |A total of 54 women were evaluated for abnormal uterine bleeding. Assessment included performance of an |

| |endometrial biopsy, a transvaginal ultra-sound scan followed by office hysteroscopy. Results of |

| |hysteroscopy were taken as the gold standard. Sensitivity and specificity of the investigations were |

| |assessed. The bleeding pattern was classified as heavy regular, irregular, postmenopausal and heavy or |

| |unscheduled bleeding on hormone replacement therapy. |

| |Results: |

| |The incidence of focal intrauterine lesions in patients presenting with abnormal bleeding was 52% for all |

| |ages and 31% for the postmenopausal group. Seventy-five percent of the patients with Hb < 11 gm% and 67% |

| |with an enlarged uterus harbored a focal pathology. The incidence of lesions in patients with heavy regular|

| |bleeding was 74%. The sensitivity and specificity of transvaginal ultrasound when compared with results of |

| |hysteroscopy was 0.60 and 0.88 respectively. A normal endometrial biopsy had a negative predictive value of|

| |51%. The sensitivity and specificity of endometrial biopsy were 0.04 and 0.83, respectively. |

| |Conclusion: |

| |Both transvaginal ultrasound and endometrial biopsy exhibited poor sensitivity for detection of focal |

| |intrauterine lesions. Considering the significantly high incidence of intrauterine lesions in patients |

| |presenting with abnormal bleeding, the most cost-effective approach appears to be proceeding with |

| |hysteroscopy early in assessment. |

|6.3 |Objectives of the study |

| |1) To evaluate the diagnostic accuracy of transvaginal sonography (TVS) compared to hysteroscopy in |

| |diagnosing abnormal uterine bleeding |

| |2) To determine whether the number of diagnostic hysteroscopies (invasive) can be reduced by TVS (non |

| |invasive) examinations |

|7 | Materials and Methods |

| |Source of data |

|7.1 |The study will be conducted on 100 women fitting into the inclusion criteria in the Department of |

| |Obstetrics and Gynaecology at Vydehi Institute of Medical Sciences & Research Centre, Bangalore. |

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|7.2 |Method of collection of data (including sampling procedure if any) |

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| |This Is a comparative observational study. |

| | |

| |After obtaining written informed consent the following will be collected on a detailed pre structured |

| |proforma. |

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| |1. Detailed history. |

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| |2. Clinical examination. |

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| |3. Transvaginal sonography |

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| |4. Hysteroscopy |

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| |5.Preoperative investigations |

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| |Sample Size: 100 women fitting into the inclusion criteria will be selected. |

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| |INCLUSION CRITERIA: |

| |1) Abnormal uterine bleeding |

| | |

| |EXCLUSION CRITERIA: |

| |1) Pregnancy |

| |2) Virgin women |

| |3) Pelvic inflammatory disease |

| |4)Morbid medical illness |

| | |

| |Methodology: |

| |Basic steps of examination in patients include: |

| |1. Written informed consent and counselling |

| | |

| |2. Detailed history |

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| |3. Physical examination- |

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| |4.Transvaginal sonography will be done and findings will be recorded |

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| |5. Hysteroscopy will be done and findings will be recorded and biopsy will be taken. |

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| |6. All the specimens collected will be sent for histopathological examination |

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| |7.Preoperative investigations-CBC,Blood grouping,Thyroid function test,renal function test ,ECG,X-RAY of |

| |chest,urine routine and microscopy,bleeding time ,clotting time, HIV,HbsAg,VDRL |

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| |8.Statistical analysis is done for above. |

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| |Statistical analysis: |

| |Sensitivity, specificity, and positive and negative predictive values of transvaginal ultrasonography and |

| |hysteroscopy in detecting abnormal uterine bleeding |

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|7.3 |Does the study require any investigations or interventions to be conducted on patients or other humans or |

| |animal? If so, please describe briefly. |

| | |

| |YES |

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| |The investigations done in the cases selected for the study are : |

| |Transvaginal ultrasonography |

| |Hysteroscopy |

| |Preoperative investigations: CBC,Blood grouping, Thyroid function test,renal function test ,ECG, X-RAY of |

| |chest,urine routine and microscopy,bleeding time ,clotting time, HIV,HbsAg,VDRL |

|7.4 |Has ethical clearance been obtained from your institution in case of 7.3 |

| | |

| |YES |

|8 |References |

| |1) Bingol B, Gunenc MZ, Gedikbasi A, Guner H, Tasdemir S,Tiras B. Comparison of diagnostic accuracy of |

| |saline infusion sonohysterography, transvaginal sonography and hysteroscopy in postmenopausal |

| |bleeding. Arch Gynecol Obstet.2011;284:111– 117 |

| | |

| |2) Sheetal G Patil, SB Bhute, SA Inamdar, Neelam S Acharya, Deepti |

| |Role of diagnostic hysteroscopy in abnormal uterine bleeding and its |

| |Histologic correlation. Journal of gynecological endoscopy and |

| |Surgery. 2009; 1:98-104. |

| | |

| |3) Makris N, Skartados N, Kalmantis K, Mantzaris G, Papadimitriou A, Antsaklis A .Evaluation of |

| |abnormal uterine bleeding by transvaginal 3-D hysterosonography and diagnostic hysteroscopy.Eur J Gynaecol |

| |Oncol. 2007;28(1):39-42. |

| |4) Erdem M, Bilgin U, Bozkurt N, Erdem A. Comparison of transvaginal ultrasonography and saline infusion |

| |sonohysterography in evaluating the endometrial cavity in pre- and postmenopausal women with abnormal |

| |uterine bleeding. Menopause.2007;14:846–852 |

| | |

| |.5) GAO Wan-li,FENG Li-min,WANG Wei-juan,LIU Xiao-chun,LI Jing-hua,WANG Jun-parison between |

| |transvaginal ultrasonographic and hysteroscopic endometrial findings in postmenopausal breast cancer |

| |tamoxifen-treated patients[J].China Journal of Endoscopy,2006,12(10):1032-1034,1037. |

| | |

| |6) Pyari JS, Rekha S, Srivastava PK, Goel M, Pandey M. A comparative diagnostic evaluation of |

| |hysteroscopy, transvaginal ultrasonography and histopathological examination in cases of abnormal uterine |

| |bleeding. J Obstet Gynaecol India.2006;56:240–243 |

| | |

| |7) Cepni I, Ocal P, Erkan S, et al. Comparison of transvaginal sonography, saline infusion sonography and|

| |hysteroscopy in the evaluation of uterine cavity pathologies. Aust N Z J Obstet Gynaecol. 2005;45:30–35 |

| | |

| |8). Kelekci S, Kaya E, Alan M, Alan Y, Bilge U, Mollamahmutoglu L. Comparison of transvaginal |

| |sonography, saline infusion sonography, and office hysteroscopy in reproductive-aged women with or without |

| |abnormal uterine bleeding. Fertil Steril. 2005;(84):682–686 |

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|9 |Signature o f the candidate |

|10 |Remarks of the guide: |

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| |FEASABLE AND RECOMMENDED |

|11.1 |Name and designation of the guide (in block |Dr. SHREEDHAR VENKATESH |

| |letters) Guide |PROFESSOR & HOD |

| | |DEPARTMENT OF OBSTETRICSAND GYNAECOLOGY |

| | |VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, |

| | |BANGALORE. |

| | | |

|11.2 |Signature | |

|11.3 |Head of the Department |Dr. SHREEDHAR VENKATESH |

| | |PROFESSOR & HOD |

| | |DEPARTMENT OF OBSTETRICSAND GYNAECOLOGY |

| | |VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, |

| | |BANGALORE. |

|11.4 |Signature | |

|12.1 | Remarks of the Principal | |

|12.2 | Signature | |

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