Age Less Than 40 Or More Than 51 Years of Age

Age Less Than 40 Or More Than 51 Years of Age

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA.
BANGALORE.
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS
(in block letters) / dr. apurva satish amarnath.
post graduate – m.s. obstetrics and gynaecology,
department of obstetrics and gynaecology,
Sri dharmasthala manjunatheshwara college of medical sciences and hospital, dharwad.
2. / NAME OF THE INSTITUTION / Sri dharmasthala manjunatheshwara college of medical sciences and hospital,
manjushree nagar, sattur,
dharwad - 580009.
3. / COURSE OF STUDY AND SUBJECT / m.s. obstetrics and gynaecology.
4. / DATE OF ADMISSION TO COURSE / 25-05-2012
5. / TITLE OF THE TOPIC / ONE YEAR CROSS SECTIONAL STUDY – TRANSVAGINAL ULTRASONOGRAPHY IN DETECTING UTERINE PATHOLOGY IN PERIMENOPAUSAL WOMEN PRESENTING WITH ABNORMAL UTERINE BLEEDING AND CORRELATION WITH HISTOPATHOLOGICAL DIAGNOSIS.
6. / Brief resume of the intended work:
6.1 Need for study:
Abnormal uterine bleeding refers to a symptom of excessive, prolonged, unexpected or acyclic bleeding regardless of diagnosis or cause. One third of outpatient visits to the gynaecologist are for abnormal uterine bleeding, and it accounts for more than 70% of all gynaecologic consults in the perimenopausal and postmenopausal years.1 Abnormal uterine bleeding not only affects the quality of life such as intimate relationships, day-to-day living but can have serious adverse consequences as anaemia or malignancy.2 The role of the clinician in a patient who presents with bleeding is twofold: first, to exclude endometrial carcinoma in women older than 40 years, and second, to identify the source of bleeding so it can be stopped or managed.3
The various modalities for assessment of uterine pathology in abnormal uterine bleeding include endometrial sampling, ultrasonography, hysteroscopy, sonohysterography and magnetic resonance imaging.4 Transvaginal ultrasonography is the accepted primary modality for the evaluation of abnormal uterine bleeding.5 It is a non invasive, low cost procedure that does not cause patient discomfort. The objective of this study is to determine the role and accuracy of transvaginal ultrasonography (TVS) in women of perimenopausal age group presenting with abnormal uterine bleeding and compare to histopathological assessment and test whether transvaginal ultrasonography is effective as a diagnostic tool for detection of uterine pathology in these women.
6.2 Review of the literature:
As per The American College of Obstetricians and Gynecologists Practice bulletin number 128: Menstrual flow outside of normal volume, duration, regularity, or frequency is considered abnormal uterine bleeding (AUB). One third of outpatient visits to the gynaecologist are for abnormal uterine bleeding, and it accounts for more than 70% of all gynaecologic consults in the perimenopausal and postmenopausal years.1
Corniţescu FI, Tănase F, Simionescu C, Iliescu D studied the clinical, histopathological and therapeutic considerations in non-neoplastic abnormal uterine bleeding in menopause transition in 2011. Menstrual irregularity was seen mainly in the 46–52 year old group (64.5%). The dominant symptom was menometrorrhagia (34%). By histopathology, leiomyofibromas were the most common cause of abnormal uterine bleeding (49.6%).6
Najeeb R, Awan AS, Bakhtiar U, Akhter S studied the role of transvaginal sonography in assessment of abnormal uterine bleeding in perimenopausal age group in 2010. 141 women with abnormal uterine bleeding were studied. Among 141 women endometrial lesions were detected in 77 cases on histopathology after dilatation and curettage, 57 (40.42%) were confirmed on transvaginal ultrasonography as endometrial pathology prior to the procedure. Among the 64 remaining patients showing normal proliferative endometrium on histopathology, 46 cases (71.87%) showed no abnormality on transvaginal examination.2
Pascual A, Graupera B, Tresserra F, Ubeda A, Hereter L, Rodriguez I, et al studied the role of colour Doppler transvaginal ultrasonography (CDTU) in detection of intrauterine pathology in those patients with abnormal uterine bleeding in 2005. 272 patients with abnormal uterine bleeding were evaluated. All patients underwent hysteroscopy to evaluate ultrasonographic findings. The sensitivity of CDTU for the diagnosis of polyp was 72.8% and for the diagnosis of myoma 85.7% concluding that CDTU can be used to discriminate women with abnormal uterine bleeding who should undergo hysteroscopy for a definitive diagnosis.7
Hosny IA, Elghawabit HS, Mosaad MM studied the role of 2D, 3D ultrasound and colour Doppler in the diagnosis of benign and malignant endometrial lesions in 2007. Forty eight patients presented with abnormal uterine bleeding. The combined use of ultrasound and Doppler was highly suggestive in the diagnosis of 19 cases of submucous leiomyoma, 16 cases of endometrial hyperplasia, 9 cases of endometrial carcinoma and 4 cases of endometrial polyp with an overall sensitivity and specificity of 93.75% and 81.25% respectively.8
Bhosle A, Fonseca M evaluated and studied the histopathological correlation of abnormal uterine bleeding in perimenopausal women in 2010. 112 perimenopausal women with abnormal uterine bleeding for a period of 6 months were evaluated. Clinical, ultrasonographic and histopathological findings were correlated. The histopathology of uterus confirmed fibroid uterus and dysfunctional uterine bleeding which correlated well with ultrasonographic examination. Clinical as well as ultrasonography proved less useful for diagnosing adenomyosis.9
Doraiswami S, Johnson T, Rao S, Rajkumar A, Vijayaraghavan J, Panicker VK studied the endometrial pathology in abnormal uterine bleeding in 620 patients who presented with abnormal uterine bleeding from June 2005–June 2006. 409 cases of isolated endometrial lesions diagnosed on histopathology were selected for the final analyses. The most common age group presenting with abnormal uterine bleeding was 41–50 years (33.5%). The commonest pattern was normal cycling endometrium (28.4%). The commonest pathology was disordered proliferative pattern (20.5%). Other causes were complications of pregnancy (22.7%), benign endometrial polyp (11.2%), endometrial hyperplasias (6.1%), carcinomas (4.4%) and chronic endometritis (4.2%). 10
6.3 Aim and Objectives of the study:
To evaluate the accuracy of transvaginal ultrasonography to diagnose endometrial and myometrial pathology in perimenopausal women presenting with abnormal uterine bleeding.
7. / Materials and Methods:
7.1 Source of data:
  • Study subjects:
Inclusion criteria:
  1. All cases of abnormal uterine bleeding in the perimenopausal age group (40-51 years) admitted for hysterectomy at Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad.
Exclusion criteria:
  1. Age less than 40 or more than 51 years of age.
  2. Women who have attained menopause.
  3. Women on hormonal treatment at the time of first presentation.
  4. Women with intrauterine device in situ.
  5. Women with endocrine disorders.
  6. Women with bleeding disorders.
  7. Women opting for medical management for abnormal uterine bleeding.
  8. Women with adnexal pathology.
  • Study area: Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad.
  • Study period: One year from 01/11/2012 to 31/10/2013.
7.2 Methods of collection of data:
  • Study design: Hospital Based, Time Bound, Cross-Sectional study.
  • Sample size: 150. Cases of abnormal uterine bleeding admitted to Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad for treatment and satisfying the study criteria will be included in the study.
  • Study instrument: Transvaginal ultrasonography using 7.5 MHz Phillips HD6 COOC1150120078 TVS probe. Ultrasound will be done by the transvaginal route. Ultrasound variables to be studied include endometrial thickness, endometrial echogenicity, endometrial-myometrial interface and myometrium.
1. Endometrial thickness will be measured in the sagittal plane of the uterus, at the thickest part of the endometrium. The thickness includes both endometrial layers. Echogenicity of the endometrium will be noted. Endometrial-myometrial interface will be noted. Any abnormal pathology such as polyps, abnormal growth will be noted.
2. Uterus will be completely assessed longitudinally and transversely for myometrial pathology. Myometrium will be studied for asymmetric myometrial thickness, globular enlargement of uterus, myometrial cysts, and linear striations.
3. Colour Doppler ultrasound will be used where required – to distinguish adenomyosis and leiomyoma, endometrial hyperplasia and endometrial polyps.
4. Endometrial biopsy will be done for all patients enrolled in the study after performing transvaginal ultrasonography.
  • Data collection: Relevant data will be collected from the patients presenting to the Department of Obstetrics and Gynaecology at Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital for 1 year to assess who can be included as candidates for the study as per the inclusion criteria. Written informed consent will be taken from all patients enrolled in the study. They will be evaluated by history, clinical examination and relevant investigations. Transvaginal ultrasound and endometrial biopsy will be done for all subjects prior to surgery (hysterectomy). The endometrial biopsy and hysterectomy specimens collected from subjects will be sent to Department Of Pathology at Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital for examination and reporting.
  • Study analysis: Appropriate statistical measurement like mean, percentage, proportion, odd’s ratio or comparison within the groups using Chi-square test will be used. p value <0.05 will be taken as statistically significant.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? (If so, please describe briefly)
Yes.
  1. Transvaginal ultrasonography.
  2. Endometrial Biopsy.
  3. Histopathological examination of hysterectomy specimen.
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of
7.3?
Yes. Clearance from the Institutional Ethical Committee of Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad is obtained.
8. / List of References:
  1. Practice Bulletin: Diagnosis of abnormal uterine bleeding in reproductive aged women. Obstet Gynecol 2012;120(1):197-206.
  2. Najeeb R, Awan AS, Bakhtiar U, Akhter S. Role of transvaginal sonography in assessment of abnormal uterine bleeding in perimenopausal age group. J Ayub Med Coll Abbottabad 2010;22(1):87-90.
  3. Goldstein SR. Abnormal uterine bleeding – Role of ultrasound. Radiol Clin N Am 2006;44:901-910.
  4. Speroff L. Abnormal uterine bleeding. Clinical Gynecologic Endocrinology and Infertility, 8th edition. Wolters Kluwer, Lippincott Williams & Wilkins 2011; 591-620.
  5. Wolfman DJ, Allison SJ, Ascher SM. Imaging of benign uterine conditions. Applied Radiology 2011; 40(11):8-15.
  6. Corniţescu FI, Tănase F, Simionescu C, Iliescu D. Clinical, histopathological and therapeutic considerations in non-neoplastic abnormal uterine bleeding in menopause transition. Rom J Morphol Embryol 2011; 52(3):759-65.
  7. Pascual A, Graupera B, Tresserra F, Ubeda A, Hereter L, Rodriguez I, Grases PJ. Colour Doppler transvaginal ultrasound for detecting intrauterine disorders in patients with abnormal uterine bleeding. Gynaecol Perinatol 2005;14(4):157–160.
  8. Hosny IA, Elghawabit HS, Mosaad MM. The Role of 2D, 3D ultrasound and color Doppler in the diagnosis of benign and malignant endometrial lesions. J Egypt Natl Canc Inst 2007;19(4):275-81.
  9. Bhosle A, Fonseca M. Evaluation and histopathological correlation of abnormal uterine bleeding in perimenopausal women. Bombay Hospital Journal 2010;52(1): 69-72.
  10. Doraiswami S, Johnson T, Rao S, Rajkumar A, Vijayaraghavan J, Panicker VK. Study of endometrial pathology in abnormal uterine bleeding. J Obstet Gynaecol India 2011;61(4):426-30.

9. / Signature of the candidate
10. / Remarks of the guide / Transvaginal ultrasonography is a simple non-invasive investigative modality in diagnosing uterine pathology in abnormal uterine bleeding. The sensitivity and specificity of transvaginal ultrasonography in diagnosis of causes of abnormal uterine bleeding needs to be assessed in our setting.
11. / Name and Designation
11.1 Guide / dr. laxmi yaliwal,
M.S. obstetrics and gynaecology,
Associate professor,
department of obstetrics and gynaecology,
Sri dharmasthala manjunatheshwara college of medical sciences and hospital ,
sattur, dharwad – 580009.
11.2 Signature
11.3 Head of the Department / DR. RATHNAMALA M DESAI,
M.D. Obstetrics and gynaecology,
professor AND HEAD OF THE DEPARTMENT ,
department of obstetrics and gynaecology,
Sri dharmasthala manjunatheshwara college of medical sciences and hospital ,
sattur, dharwad – 580009.
11.4 Signature
12. / 12.1 Remarks of the Principal and Chairman
12.2 Signature

INFORMED CONSENT

Serial no:

I,______d/o, w/o______hereby state that I involve myself voluntarily as a subject in the study conducted by Dr. Apurva Satish Amarnath on “One year cross sectional study – Transvaginal ultrasonography in detecting uterine pathology in perimenopausal women presenting with abnormal uterine bleeding and correlation with histopathological diagnosis”. I understand that I will undergo transvaginal ultrasound and endometrial biopsy as a part of my preoperative evaluation and that the hysterectomy specimen will be sent for histopathological examination for final confirmation of diagnosis. The purposes of the study have been explained to me to the best of my understanding in my own understandable language. I am aware that the investigations being carried out for me are those that are done for all women presenting with my symptoms and that the study is being carried out for my benefit as well as those women suffering from symptoms similar to mine. I agree to give my consent to take part in the study.

Date: Signature of subject:

Address:

Date: Signature of witness:

Date: Signature of the investigator:

Dr. Apurva Satish Amarnath

PROFORMA

Demographic Data

Serial no: MR no: IP no:

Name: Address:

Age: Education: Occupation: SES:

Complaints

Yes/no / Duration
Menorrhagia
Metrorrhagia
Menometrorrhagia
Polymenorrhoea
Oligomenorrhoea
Other complaints

Menstrual History

Age of menarche: LMP:

Previous cycles: Present cycles:

Obstetric History

Married life: LCB:

Parity: Contraception:

Past History

DM/ HTN/ TB/ Epilepsy/ Asthma/ Thyroid Disorders/ Surgery/ Blood transfusion

Examination

PR / RR / BP / Temp / Height / Weight / BMI / CVS / RS / Pallor

PA:

PS:

PV:

Investigations:: Hb: Date:

Transvaginal Ultrasound: Date:

Uterus: Position:

Measurement: Length: Breadth: Width:

Endometrial thickness:

Junctional zone:

Myometrium:

Abnormality:

Cervix:

Ovary: Right Left

Doppler:

Endometrial Biopsy: Date:

Report:

Hormonal treatment:

Drug / Dose / Duration

Hysterectomy: Date:

VH / NDVH / TAH / TLH / BSO

Histopathology: Date:

Report:

FINAL DIAGNOSIS:

Date: Signature:

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