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 |
| | |
| | |
| |Comparative study of the diagnostic accuracy of transvaginal sonography versus hysteroscopy in abnormal |
| |uterine bleeding |
| | |
| | |
| | |
|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 |
| | |
| |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. |
| | |
|7.2 |Method of collection of data (including sampling procedure if any) |
| | |
| |This Is a comparative observational study. |
| | |
| |After obtaining written informed consent the following will be collected on a detailed pre structured |
| |proforma. |
| | |
| |1. Detailed history. |
| | |
| |2. Clinical examination. |
| | |
| |3. Transvaginal sonography |
| | |
| |4. Hysteroscopy |
| | |
| |5.Preoperative investigations |
| | |
| |Sample Size: 100 women fitting into the inclusion criteria will be selected. |
| | |
| | |
| | |
| | |
| |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 |
| | |
| |3. Physical examination- |
| | |
| |4.Transvaginal sonography will be done and findings will be recorded |
| | |
| |5. Hysteroscopy will be done and findings will be recorded and biopsy will be taken. |
| | |
| |6. All the specimens collected will be sent for histopathological examination |
| | |
| |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 |
| | |
| |8.Statistical analysis is done for above. |
| | |
| |Statistical analysis: |
| |Sensitivity, specificity, and positive and negative predictive values of transvaginal ultrasonography and |
| |hysteroscopy in detecting abnormal uterine bleeding |
| | |
| | |
| | |
|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 |
| | |
| | |
| | |
| |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: |
| | |
| |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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