Pyrexia of unknown origin (PUO) and the cost of care in a tertiary care institute in Sri Lanka.

BACKGROUND: Despite advancements in diagnostic technology, pyrexia of unknown origin (PUO) remains a clinical concern. Insufficient information is available regarding the cost of care for the management of PUO in the South Asian Region. METHODS: We retrospectively analyzed data of patients with PUO from a tertiary care hospital in Sri Lanka to determine the clinical course of PUO and the burden of the cost incurred in the treatment of PUO patients. Non-parametric tests were used for statistical calculations. RESULTS: A total of 100 patients with PUO were selected for the present study. The majority were males (n = 55; 55.0%). The mean ages of male and female patients were 49.65 (SD: 15.55) and 46.87 (SD: 16.19) years, respectively. In the majority, a final diagnosis had been made (n = 65; 65%). The mean number of days of hospital stay was 15.16 (SD; 7.81). The mean of the total number of fever days among PUO patients was 44.47 (SD: 37.66). Out of 65 patients whose aetiology was determined, the majority were diagnosed with an infection (n = 47; 72.31%) followed by non-infectious inflammatory disease (n = 13; 20.0%) and malignancies (n = 5; 7.7%). Extrapulmonary tuberculosis was the most common infection detected (n = 15; 31.9%). Antibiotics had been prescribed for the majority of the PUO patients (n = 90; 90%). The mean direct cost of care per PUO patient was USD 467.79 (SD: 202.81). The mean costs of medications & equipment and, investigations per PUO patient were USD 45.33 (SD: 40.13) and USD 230.26 (SD: 114.68) respectively. The cost of investigations made up 49.31% of the direct cost of care per patient. CONCLUSION: Infections, mainly extrapulmonary tuberculosis was the most common cause of PUO while a third of patients remained undiagnosed despite a lengthy hospital stay. PUO leads to high antibiotic usage, indicating the need for proper guidelines for the management of PUO patients in Sri Lanka. The mean direct cost of care per PUO patient was USD 467.79. The cost of investigations contributed mostly to the direct cost of care for the management of PUO patients.

Late presentation of a cauda equina lesion with a vulval abscess: a case report.

BACKGROUND: Cauda equina syndrome is a rare clinical condition that requires prompt diagnosis and timely surgical decompression with postoperative rehabilitation to prevent devastating complications. CASE PRESENTATION: A 55-year-old Sinhalese woman presented with a vulval abscess, with a history of involuntary leakage of urine for the last 7 years. Her sexual activity has been compromised due to coital incontinence, and she had also been treated for recurrent urinary tract infections during the last 7 years. On examination, a distended bladder was found. Neurological examination revealed a saddle sensory loss of S2-S4 dermatomes. There was no sensory loss over the lower limbs. Bladder sensation was absent, but there was some degree of anal sphincter tone. Motor functions and reflexes were normal in the limbs. Magnetic resonance imaging revealed L5-S1 spondylolisthesis. Ultrasound imaging confirmed the finding of a distended bladder, in addition to bilateral hydroureters with hydronephrosis. An incision and drainage with concomitant intravenous antibiotics were started for the vulval abscess. An indwelling catheter was placed to decompress the bladder and to reduce vulval excoriations due to urine. Bilateral ureteric stenting was performed later for persistent hydronephrosis and hydroureter despite an empty bladder. CONCLUSION: This is a tragic case that illustrates the devastating long-term sequelae that ensues if cauda equina syndrome is left undiagnosed. It reiterates the importance of prompt referral and surgical decompression.

Elevated CA 125 level in a mucinous cystadenoma and a teratoma: a case report.

BACKGROUND: The presence of a suspicious ovarian cyst with elevated cancer antigen 125 level in a woman of reproductive age poses a serious therapeutic dilemma. Mature cystic teratomas and mucinous cystadenomas may also cause an increase in cancer antigen 125. CASE PRESENTATION: A 43-year-old Sinhalese woman with a history of anovulatory subfertility for 5 years presented with heavy menstrual bleeding and secondary dysmenorrhea of 6 months' duration. Imaging (pelvic ultrasound and computed tomography of the abdomen and pelvis) revealed a hemorrhagic cyst (6 × 4 cm) on the right side and a multilocular cyst with solid areas (10 × 7 cm) on the left side. Her cancer antigen 125 level was 2715 U/ml. Following a multidisciplinary team meeting, a fertility-sparing staging laparotomy was performed, which included right cystectomy, left oophorectomy, infracolic omentectomy, and peritoneal washings. Histology revealed a mucinous cystadenoma of the right ovary and a mature cystic teratoma on the left ovary. No malignant cells were observed in peritoneal washings. The patient's cancer antigen 125 level dropped to 74.8 U/ml 1 month after surgery. CONCLUSION: Rarely, teratomas and mucinous cystadenomas may also give rise to an extremely high cancer antigen 125 level. The risk of malignancy index and risk of malignancy algorithm may both be misleading in these instances. Therefore, multidisciplinary input, fertility-sparing surgery, and follow-up are paramount to achieve optimal treatment and patient satisfaction.

Vaginal, sexual and urinary symptoms following hysterectomy: a multi-centre randomized controlled trial.

BACKGROUND: Hysterectomy is the most common major gynaecological procedure. The aim of this study was to study vaginal, sexual and urinary symptoms following total abdominal hysterectomy (TAH), non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH) in a low resource setting. METHODS: A multi-centre randomized controlled trial (RCT) was conducted in two public sector hospitals in Sri Lanka. Participants were patients requiring hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus> 14 weeks, previous pelvic surgery, medical illnesses which contraindicated laparoscopic surgery, and those requiring incontinence surgery or pelvic floor surgery.Vaginal, sexual function and urinary symptoms were assessed by the validated translations of ICIQ-VS and ICIQ-FLUTS questionnaires. Post-operative improvement (pre-operative - post-operative) was assessed. RESULTS: There was an improvement (median (IQ1-IQ3) in vaginal symptoms [TAH 6(2-8) vs 4(0-8), p < 0.001; NDVH 6(4-8.5) vs 5(0-8), p < 0.001; TLH 4(2-10.5) vs 4(0-10), p < 0.001], urinary flow symptoms [TAH 2(1-4) vs 1 (0-3), p < 0.001; NDVH 3 (2-5) vs 2 (0.5-4), p < 0.001; TLH 1(1-4) vs 1(0-3), p < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0), p = 0.20; NDVH 0(0-1) vs 0(0-0.8), p < 0.05; TLH 0(0-0) vs 0(0-0), p < 0.05] and urinary incontinence symptoms [TAH 0(0-2) vs 0(0-2), p = 0.06; NDVH 0(0-3) vs 0(0-3), p < 0.001; TLH 0(0-3) vs 0(0-2), p < 0.05] at 1-year (TAH n = 47, NDVH n = 45, TLH n = 47). There was an improvement in sexual symptoms only in the TLH group [TAH 0(0-11.5) vs 0(0-14), p = 0.08); NDVH 0(0-0) vs 0(0-0), p = 0.46; TLH 0(0-0) vs 0(0-4), p < 0.05].There was no significant difference among the three different routes in terms of vaginal symptoms score [TAH 2 (0-2), NDVH 0 (0-2), TLH 0 (0-2), p = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2), p = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1), p = 0.35] at 1-year. CONCLUSIONS: There was a post-operative improvement in vaginal symptoms and urinary symptoms in all three groups. There was no significant difference in pelvic organ symptoms between the three routes; TAH, NDVH and TLH. TRIAL REGISTRATION: Sri Lanka clinical trials registry, SLCTR/2016/020 and the International Clinical Trials Registry Platform, U1111-1194-8422, on 26 July 2016. Available from: http://slctr.lk/trials/515.

Non-alcoholic fatty liver disease and pregnancy complications among Sri Lankan women: A cross sectional analytical study.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the commonest cause of liver disease worldwide and is the hepatic manifestation of metabolic syndrome. Effects of NAFLD on pregnancy is still unclear with few studies showing an association to gestational diabetes and pre-eclampsia. We aimed to describe the association between the NAFLD and pregnancy complications. This is the first study, to our knowledge, in a South Asian population. METHOD: A cross sectional analytical study was done in Teaching Hospital, Ragama, Sri Lanka. Women carrying a singleton pregnancy, admitted for delivery were assessed for NAFLD with liver ultrasound scan. Data were extracted from interviewer administered questionnaire and antenatal and inpatient records. Pregnancy complications and labour outcomes were compared between the women with NAFLD and women without NAFLD (non-NAFLD). RESULTS: Out of the 573 women who participated, 18.2% (n = 104) were found to have NAFLD. Out of them, 58 (55.8%), 32(30.8%), and 14(13.5%) had fatty liver grade 1,2 and 3 respectively. Women with NAFLD were 2 times more likely to develop gestational hypertension and pre-eclampsia compared to the women in the non-NAFLD group, after adjusting for BMI, age and Hyperglycaemia in pregnancy [Adjusted OR 2.09, (95% CI 1.07-4.10)]. There was no association between the grade of steatosis and a composite outcome of gestational hypertension and pre-eclampsia, within the NAFLD group. Composite outcome of gestational diabetes mellitus and diabetes in pregnancy diagnosed during pregnancy was a significant complication in the NAFLD group compared to non-NAFLD group in the bivariate analysis (27.2% vs 17.7%; p<0.05), but the significance disappeared after adjusting for confounders. The current study did not demonstrate a significant association between NAFLD with preterm labour, caesarean section rate, low birth weight, and Apgar score of the baby. CONCLUSION: Women with NAFLD had a 2-fold higher risk of developing gestational hypertension and pre-eclampsia during pregnancy compared to women without NAFLD, after controlling for other confounding variables.

Challenges of Costing a Surgical Procedure in a Lower-Middle-Income Country.

BACKGROUND: It is vital to enquire into cost of health care to ensure that maximum value for money is obtained with available resources; however, there is a dearth of information on cost of health care in lower-middle-income countries (LMICs). Our aim was to develop a reproducible costing method for three routes of hysterectomy in benign uterine conditions: total abdominal (TAH), non-descent vaginal (NDVH) and total laparoscopic hysterectomy (TLH). METHODS: A societal perspective with a micro-costing approach was applied to find out direct and indirect costs. A total of 147 patients were recruited from a district general hospital (Mannar) and a tertiary care hospital (Ragama). Costs incurred from preoperative period to convalescence included direct costs of labour, equipment, investigations, medications and utilities, and indirect costs of out-of-pocket expenses, productivity losses, carer costs and travelling. Time-driven activity-based costing was used for labour, and top-down micro-costing was used for utilities. RESULTS: The total cost [(interquartile range), number] of TAH was USD 339 [(308-397), n = 24] versus USD 338 [(312-422), n = 25], NDVH was USD 315 [(316-541), n = 23] versus USD 357 [(282-739), n = 26] and TLH was USD 393 [(338-446), n = 24] versus USD 429 [(390-504), n = 25] at Mannar and Ragama, respectively. The direct cost of TAH, NDVH and TLH was similar between the two centres, whilst indirect cost was related to the setting rather than the route of hysterectomy. CONCLUSIONS: The costing method used in this study overcomes logistical difficulties in a LMIC and can serve as a guide for clinicians and policy makers in similar settings. TRIAL REGISTRATION: The study was registered in the Sri Lanka clinical trials registry (SLCTR/2016/020) and the International Clinical Trials Registry Platform (U1111-1194-8422) on 26 July 2016.

An atypical presentation of an ovarian lymphoma: a case report.

BACKGROUND: Ovarian lymphoma has a varied clinical presentation and rarely presents with heavy menstrual bleeding. It may occur de novo or secondary to systemic disease and macroscopically appear as solid ovarian tumors. CASE PRESENTATION: A 32-year-old Tamil woman presented with heavy menstrual bleeding of 4 months' duration. On examination she was anemic with no lymphadenopathy. A large immobile pelvic mass and three firm nodules were found involving her vaginal walls. Ultrasonography suggested a fibroid uterus with two large pedunculated fibroids. Following preoperative optimization an endometrial sampling and biopsy of the nodules were done. Subsequently, histology revealed proliferative phase endometrium. The vaginal nodules showed lymphoid tissue. She presented a week later with an undulating fever and features of acute abdomen with clinical evidence of ascites. During an emergency laparotomy two large solid ovarian masses, gross ascites, pelvic lymph nodes, para-aortic lymph nodes, mesenteric lymph nodes, omental deposits, and a 24-week-size uterus were found. Bilateral oophorectomy was done. Laboratory investigations revealed raised lactate dehydrogenase with normal serum ß-human chorionic gonadotropin, alpha-fetoprotein, and cancer antigen-125 levels. Histology of ovarian specimens revealed a diffuse large B cell lymphoma. A bone marrow biopsy revealed more than 80% infiltration with lymphoid cells. Two weeks after the laparotomy a computed tomography of her chest, abdomen, and pelvis revealed a pelvic mass, gross ascites, omental deposits, hepatosplenomegaly, and enlarged lymph nodes above and below her diaphragm. Immunohistochemistry confirmed the diagnosis of B cell lymphoblastic lymphoma. She was classified as stage IV E non-Hodgkin's lymphoma on the Ann Arbor staging system. CONCLUSION: This is an atypical presentation of an ovarian lymphoma. The atypical presentations of ovarian lymphomas can lead to diagnostic dilemmas.

Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: study protocol for a randomized controlled trial.

BACKGROUND: Hysterectomy is the commonest major gynaecological surgery. Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. However, most comparative studies on hysterectomy are between two approaches. There is also a relative absence of data on long-term outcomes on quality of life and pelvic organ function. There is no single study which has considered quality of life, pelvic organ function and cost-effectiveness for the three main types of hysterectomy. Therefore, the objective of this study is to provide evidence on the optimal route of hysterectomy in terms of cost-effectiveness by way of a three-armed randomized control study between non-descent vaginal hysterectomy, total laparoscopic hysterectomy and total abdominal hysterectomy. METHODS: A multicentre three-armed randomized control trial is being conducted at the professorial gynaecology unit of the North Colombo Teaching Hospital, Ragama, Sri Lanka and gynaecology unit of the District General Hospital, Mannar, Sri Lanka. The study population is women needing hysterectomy for non-malignant uterine causes. Patients with a uterus > 14 weeks, previous pelvic surgery, those requiring incontinence surgery or pelvic floor surgery, any medical illness which caution/contraindicate laparoscopic surgery and who cannot read and write will be excluded. The main exposure variable is non-descent vaginal hysterectomy and total laparoscopic hysterectomy. The control group will be patients undergoing total abdominal hysterectomy. The primary outcome is time to recover following surgery, which is the earliest time to resume all of the usual activities done prior to surgery. In total, 147 patients (49 per arm) are needed to have 80% power at α-0.01 considering a loss to follow-up of 20% to detect a 7-day difference between the three routes; TLH versus TAH versus NDVH. The economic evaluation will take a societal perspective and will include direct costs in relation to allocation of healthcare resources and indirect costs which are borne by the patient. A micro-costing approach will be adopted to calculate direct costs from the time of presentation to the gynaecology clinic up to 6 months after surgery. Incremental cost-effectiveness ratios (ICER) will be obtained by calculating the incremental costs divided by the incremental effects (time to recover and QALYs gained) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. DISCUSSION: The cost of the procedure, quality of life and pelvic organ function following the three main routes of hysterectomy are important to clinicians and healthcare providers, both in developed and developing countries. TRIAL REGISTRATION: The study was registered in the Sri Lanka clinical trials registry (SLCTR/2016/020) and the International Clinical Trials Registry Platform ( U1111-1194-8422 ) on 26 July 2016.

Validation of the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) in two south- Asian languages.

INTRODUCTION: The multifaceted nature of pelvic floor disorders means that a systematic evaluation is required for optimal treatment outcome. It is also generally acknowledged that a valid tool is necessary to objectively assess symptoms reported by affected women. METHODS: The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) questionnaire was translated to Sinhala and Tamil and a validation study carried out among women attending gynecology clinics at North Colombo Teaching Hospital, Ragama, and the district general hospitals Mannar and Vavuniya. RESULTS: Content validity was assessed by the level of missing answers, which was < 4% and 2% for each item in Sinhala and Tamil, respectively. Construct validity was assessed by the ability of the questionnaire to differentiate between patients and controls. Both differentiated patients from controls on vaginal symptoms score (VSS) (p < 0.001), sexual symptoms score (SSS) (p < 0.01), and quality of life (QoL) (p < 0.001). There was a strong positive correlation between Pelvic Organ Prolapse Quantification (POP-Q) scores and VSS (Sinhala r s = 0.64, p < 0.001, Tamil r s = 0.65, p < 0.001), and QoL (Sinhala r s = 0.49, p < 0.001, Tamil r s = 0.60, p < 0.001). Internal consistency as assessed using Cronbach's coefficient alpha: 0.78 (0.76-0.78) and 0.83 (0.80-0.84) in Sinhala and Tamil, respectively. Test-retest reliability was assessed by weighted kappa scores (Sinhala 0.58-0.88 and Tamil 0.76-0.90). Both questionnaires were sensitive to change and showed that VSS and QoL improved following surgery (Wilcoxon matched-pairs signed-rank test p < 0.001). CONCLUSION: The validated Sinhala and Tamil translations of ICIQ-VS will be useful for assessing vaginal and sexual symptoms among women speaking Sinhala and Tamil.

Translation and validation of ICIQ-FLUTS for Tamil-speaking women.

AIMS: Research in to lower urinary tract symptoms (LUTS) in women in South Asia is hampered by lack of validated tools. Our aim was to validate the International Consultation on Incontinence Modular Questionnaire on Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) from English to Tamil. METHOD: After translation to Tamil, a validation study was carried out among women attending the gynecology clinic at District General Hospital-Mannar. RESULTS: Content validity assessed by the level of missing data was <2%. Construct validity was assessed by the ability of the questionnaire to identify patients with incontinence (n = 45) from controls (n = 93) using the incontinence score [patients = 7.7 standard deviation (SD) = 4.7, controls = 1.4 SD = 2.2, p < 0.001] and those with symptomatic anterior wall prolapse (n = 16) from controls (n = 93) using voiding symptoms score (patients = 4.8 SD = 2.3, controls = 0.3 SD = 0.8, p < 0.001). Internal consistency was assessed using Cronbach's coefficient alpha score [0.80 (0.77-0.81)]. Test-retest reliability assessed by weighted kappa (κ) ranged from 0.73 to 0.87. Patients with incontinence (n = 30, pretreatment incontinence score = 7.9, SD = 4.9 versus posttreatment incontinence score = 3.3, SD = 3.1) and symptomatic anterior wall prolapse (n = 14, preoperative voiding symptoms score = 4.9 SD = 2.5 versus postoperative voiding symptoms score = 0.9 SD = 1.5) showed an improvement with treatment (Wilcoxon matched--pairs signed-rank test p < 0.001 and p < 0.01, respectively). An incontinence score ≥ 3 (sensitivity = 86.7%, specificity = 78.4%) and a voiding symptoms score ≥ 3 (sensitivity = 87.5%, specificity = 96.2%) detected any form of incontinence and symptomatic anterior wall prolapse, respectively. CONCLUSION: Tamil translation of ICIQ-FLUTS retained the psychometric properties of the original English questionnaire and will be an invaluable tool to detect LUTS among Tamil-speaking women.