6. BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR THE STUDY

Adnexal mass is a common presentation in clinical practice and can be of gynaecological or non-gynaecological origin. The term adnexa is derived from the pleural form of the Latin word meaning "appendage." The adnexa of the uterus include the ovaries, fallopian tubes, and structures of the broad ligament. Most frequently, adnexal masses refer to ovarian masses or cysts. Howeverer, paratubal cysts, hydrosalpinx, and other nonovarian masses are also included within the broader definition of adnexal masses. Several other anatomical structures are important to identify, both for the evaluation of other sources of masses within the pelvis and during surgical procedures to prevent damage to nearby organs and structures.

The clinical presentation of an adnexal mass can be variable, but patients are often asymptomatic. Patients may present with masses that are found at the time of a pelvic examination, at the time of a radiologic examination for another diagnosis or at the time of a surgical procedure.

Adnexal masses present a diagnostic dilemma; the differential diagnosis is extensive, and most masses are benign.(1,2,3) However, without histopathologic tissue diagnosis, a definitive diagnosis is generally precluded. Gynecologists must evaluate the likelihood of a concerning pathologic process using clinical and radiologic information and balance the risk of surgical intervention for a benign versus malignant process. Since ovaries produce physiologic cysts in menstruating women, the likelihood of a benign process is higher in women of reproductive age. In contrast, the presence of an adnexal mass in prepubertal girls and postmenopausal women heightens the risk of a malignant neoplastic etiology.

Sonography including Doppler study are useful to make early and more specific diagnosis and to develop individual strategies to avoid unnecessary interventions. The measurement of vascular resistance with Doppler is an important complement to trans abdominal sonography (TAS) and transvaginal sonography (TVS).

Histopathology is taken as gold standard for evaluation of benign and malignant adnexal masses(4).

Early, correct and detailed diagnostics, adequate preoperative stage evaluation and preparation as well as up-to-date therapy are obligatory for adequate treatment of ovarian carcinoma (5)

This study will be done to find out diagnostic value of clinical findings, ultrasonography and its correlation with laparotomy and histopathological findings in the diagnosis of adnexal masses.

6.2 REVIEW OF LITERATURE

1) Jelena Dotlić et al in 2010 conducted a study to analyze pre- and postoperative findings in patients with adnexal masses in order to identify factors which could preoperatively imply on the nature and stage of the tumor. 81 patients with adnexal masses who were treated in a 6-month period had their epidemiologic, gynecologic and standard laboratory analyses taken prior to surgery. Also, clinical and ultrasonographic check up of pelvic organs was performed, as well as calculation of body mass index (BMI) and risk of malignancy index (RMI). After surgery we analyzed histopathological (HP) findings of tumors as a mean of final diagnosis and staging. There was a statistically significant positive correlation between HP categories (benign, malignant) and RMI categories (low, intermediate and high risk) of all the patients (high risk, more malignant HP).(6)

2) Elizabeth Asch et al in 2008 conducted a study to quantify, categorize, and illustrate discrepancies between preoperative radiologic, surgical and pathologic diagnosis and to assess the potential impact of discrepancies on clinical care. Adnexal masses reported by pathology during a 16-month period were included if prior imaging had been performed. Up to 3 sonographic examinations were reviewed by a gynecologic sonographer and compared with the reported pathologic findings. This study illustrated the importance of imaging, surgical, and histologic correlation in assessing the diagnostic accuracy of sonography of adnexal masses.(7)

3) Kusnetzoff et al in 1998 conducted a study was conducted to define the clinical value of physical examination, CA125, transvaginal sonography and echo-Doppler in the preoperative diagnosis of adnexal masses where 130 patients with adnexal masses were prospectively studied. Sensitivities for transvaginal sonography (TVS) were: 87.5% and 82.6% for pre- and postmenopausal patients, while specificity was 75.4% and 64.7%, respectively. For premenopausal patients the CA125 cut-off point that provides the best clinical usefulness is 100 IU/ml, yielding 94.4% specificity and 53.3% sensitivity. In postmenopausal women 35 IU/ml provides the highest accuracy and sensitivity. Combination of TVS and CA125 were: 100% specificity in premenopausal and 91.1% in postmenopausal patients.(8)

4) Radosa MP et al conducted a study from 2002 to 2008.A total of 1362 surgical explorations with indication of an adnexal mass were included in this study.

It was concluded that preoperative assessment of an adnexal mass may be guided by the patient's menopausal state. In premenopausal patients, expert sonography is helpful for preoperative differentiation between benign and malignant lesions; in postmenopausal patients, the use of triage strategies of either CA-125 serum measurement or RMI combined with expert sonography can be recommended.(9)

6) Nagrath Arun et al in 2007 conducted a study in department of obstetrics and gynecology, S N college, Agra where clinically diagnosed ovarian cysts in 50 women were evaluated by sonography, color flow mapping and pulsed Doppler waveform studies. On the basis of these findings they were classified into simple cysts, complex cysts, complex cysts with solid areas and solid cysts. These were correlated with laparotomy and histopathology findings. It was concluded that both colour flow mapping and pulsed Doppler waveform studies are helpful in predicting malignancy in ovarian cysts.(10)

8) Abdominal ultrasonography is very useful as an adjuvant to transvaginal ultrasonography because transvaginal ultrasonography may not provide an accurate image of masses that are both pelvic and abdominal. Information provided should include the size and consistency of the mass (cystic, solid, or mixed), whether the mass was unilateral or bilateral, presence or absence of septations, mural nodules, papillary excrescences, and free fluid in the pelvis.

Ultrasound findings should be correlated with physical findings, and a refined differential diagnosis should be constructed (ACOG 2007)(11)

9) Anuradha Khanna et al in 2002 conducted a study where one hundred and sixty five women with adnexal masses underwent TAS and TVS real time gray scale ultrasonography was followed by color Doppler sonography. After laparotomy, the gross and cross sectional findings of all specimens were correlated with USG findings and all specimens were sent for biopsy. The histopathological diagnosis was considered final and gold standard in all cases. The study showed a sensitivity of 100%, specificity 93.1% positive predictive value 98.5% and negative predictive value of 100% for color Doppler.(4)

11) Berek and Novak’s gynecology. 15th ed 2012

During reproductive years, most common ovarian masses are benign. Ovarian masses can be functional or neoplastic and neoplastic ones can be benign or malignant. Most ovarian tumours (80%-85%) are benign. The most common symptoms include abdominal distension, abdominal pain or discomfort, urinary or gastrointestinal symptoms. In pelvic findings, masses that are unilateral, cystic, mobile and smooth are most likely to be benign whereas those that are bilateral, solid, fixed, irregular and associated with ascites and a rapid growth rate are malignant. Lab studies indicated in reproductive age are pregnancy test, cervical cytology and complete blood count. Imaging studies include pelvic ultrasonography.

Transvaginal and transabdominal ultrasonography are complementary in diagnosis of pelvic

Masses.(12)

6.3 OBJECTIVE OF THE STUDY

1. To correlate the clinical, sonological findings with histopathological findings in the diagnosis of adnexal masses.

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA

Patients presenting with adnexal masses at Mysore Medical College and Research Institute between December 2013 to November 2014.

Duration of study-18 months

SAMPLE SIZE: All the cases will be considered for the study for the period of one year from December 2013 to November 2014. 100% enumeration technique will be used.

INCLUSION CRITERIA:

1) All cases with clinical diagnosis of adnexal masses.

2) Women of all age groups.

EXCLUSION CRITERIA:

1) Pregnancy with adnexal masses. 2) Non gynaecological causes of adnexal mass.

3) Patients who do not get operated.

7.2 METHOD OF COLLECTION OF DATA (including sampling procedure, if any)

All patients with adnexal masses who present during the study period in Cheluvamba hospital, Mysore, detailed history about demographic factors, presenting complaints and menstrual histories are obtained. Gynecologic examination consisting of abdominal, bimanual and per rectal examination done. Standard laboratory analyses taken prior to surgery.

An ultrasound examination consisting of both transvaginal and transabdominal sonograms with colour Doppler are done to evaluate the adnexal mass.

Following surgery, specimens are sent for histopathological examination and the reports are correlated with pre- operative clinical and imaging findings.

Accuracy of clinical and ultrasound diagnosis was assessed.

Sensitivity, specificity, negative predictive value and positive predictive value of clinical findings and sonography for each adnexal mass will be noted and tabulated using SPSS for windows(v16).

STATISTICAL METHODS USED:

• Chi square test

• Contingency table analysis.

• Sensitivity, Specificity, PPV, NPV

• Proportion

• Multiple bar charts, pie charts 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.

 Complete blood count

 Blood grouping and cross matching

 HIV, HBsAg, VDRL

 RFT

 LFT

 TFT

 Chest x ray, ECG

 Transabdominal and transvaginal USG pelvis with Doppler

 B-Hcg,CA-125

 UPT

7.4 Has an ethical clearance been obtained from your institution (in case of 7.3)?

8. List of referances

1. ACOG Practice Bulletin. Management of adnexal masses. Obstet Gynecol. Jul 2007;110(1):201-14. 2. Drake J. Diagnosis and management of the adnexal mass. Am Fam Physician. May 15 1998;57(10):2471-6, 2479-80. 3. Gallup DG, Talledo E. Management of the adnexal mass in the 1990s. South Med J. Oct 1997;90(10):972-81. 4. Anuradha Khanna, Shweta Garg, R C Shukla, Mohan Kumar. Singapore Journal of Obstetrics and Gynaecology March 2002; 33(1): 35-36

5. Chang JK, Tian C, Monk BJ, Herzog T, Kapp DS, Bell J, et al. Prognostic factors for high- risk early-stage epithelial ovarian cancer: a Gynecologic Oncology Group study. Cancer 2008; 112(10): 2202–10.

6.Jelena Dotlić, Milan Terzić, Ivana Likić, Jasmina Atanacković, Nebojša Ladjević. Volumen 68, Broj 2010. DOI: 10.2298/VSP1110861D

7. Elizabeth Asch, AB, Deborah Levine et al J Ultrasound Med 2008; 27:327–342

8. Kusnetzoff, Gnochi, Damonte, Sananes, Giaroli, Di Paola and Sardi (1998), Differential diagnosis of pelvic masses: Usefulness of CA125, transvaginal sonography and echo- Doppler. International Journal of Gynecological Cancer, 8: 315–321. doi: 10.1046/j.1525- 1438.1998.97107.x

9. Radosa MP, Camara O, Vorwergk J, Diebolder H, Winzer H, Mothes A, Gajda M, Runnebaum IB. Department of Gynecology and Obstetrics, Jena University Hospital, Jena, Germany. Int J Gynecol Cancer. 2011 Aug;21(6):1056-62. doi: 10.1097/IGC.0b013e3182187eb0.

10. Nagrath Arun , Malhotra Narendra , Gupta Nidhi , Mathur Vanaj. J Obstet Gynecol India Vol.57,No.6: November/December 2007 Pg 530-534 11. ACOG Practice Bulletin Management of Adnexal Masses VOL. 110, NO. 1, JULY 2007 Pg:203 12. Jonathan S.Berek. Benign diseases of the female reproductive tract. In Berek and Novak’s gynecology. 15th ed 2012;411,415.