comparison of laparoscopic findings with tuberculosis polymerase chain reaction in diagnosis of genital tuberculosis amongst sub fertile women:RCT (Preprint)

BACKGROUND INTRODUCTION •There exists a lot of diagnostic dilemma for genital tuberculosis in the available literature No single test is found confirmatory except for wet culture and histopathological positivity which may become paucibacillary extrapulmonary sites and time consuming too. •Polymerase Chain Reaction is a rapid molecular method for the identification of nucleic acid sequences specific to M. tuberculosis and other mycobacteria in tissue samples of patients with genital TB. PCR assays can detect <10 bacilli/ml including dead bacilli and has a testing time of 8-12 h. •The sensitivity of PCR is higher than culture and histopathology and specificity may be as high as 100 percent in detecting, but also it gives false-positive result hence cannot be used alone •Hence in the present study, we would like to correlate the findings of diagnostic laparoscopy and tuberculosis polymerase chain reaction in diagnosing genital tuberculosis amongst subfertile women. OBJECTIVE AIM This study aimed to find out the comparison between laparoscopic findings and tuberculosis polymerase chain reaction in the diagnosis of genital tuberculosis. OBJECTIVES 1. To take a detailed history, conduct a clinical examination and basic investigations to rule out tuberculosis amongst subfertile women attending infertility OPD of AVBRH 2. To perform diagnostic hysterolaparoscopy of recruited women for any findings of genital tuberculosis and at the same time, collecting endometrial sampling for tuberculosis polymerase chain reaction 3. To correlate the positivity of tuberculosis polymerase chain reaction with laparoscopic findings suggestive of genital TB. METHODS MATERIALS AND METHODS • Study design - Randomized Comparative Interventional Study • Sample size - 50 • Inclusion criteria - All participants will be women with complaints of infertility from whom female genital tuberculosis (FGTB) may be suspected as a cause of infertility. • Exclusion criteria – • Women who have other explained causes of infertility such as anatomical. • Acute PID • Place of study –AVBRH Sawangi (Meghe) Wardha • Methodology- • After selecting the patient according to inclusion criteria women will be posted for a diagnostic laparoscopy and endometrial aspirate will be sent for TB PCR • After due collection of samples and obtaining of results, the results will be comprehensively gathered and data analyzed, the diagnostic tests such as pelvic USG , HPE and also laparoscopy and PCR of endometrial aspirate for patient who are affording ; after which these modalities will be correlated for accurately diagnosing female genital tuberculosis, by calculating sensitivity, specificity, positive predictive value and negative predictive value of the same SAMPLE SIZE CALCULATION n= Za/2 x Px(1-P) / d2 Where Za/2 is the level of significance at 5% i.e. 95% confidence interval = 1.96 P = prevalence of genital TB = 3% = 0.07 d= desired error of margin = 7% = 0.07 n = 1.96x 1.96 x 0.07 x (1-0.07)/ 0.07 x 0.07 = 52 50 patients needed in the study RESULTS EXPECTED OUTCOME We would like to correlate the findings of diagnostic laparoscopy and tuberculosis polymerase chain reaction in diagnosing genital tuberculosis amongst subfertile women This would help to detect infertility cases earlier CONCLUSIONS We would like to correlate the findings of diagnostic laparoscopy and tuberculosis polymerase chain reaction in diagnosing genital tuberculosis amongst subfertile women This would help to detect infertility cases earlier