Osteitis pubis following laparoscopic Burch colposuspension: A case report.

Osteitis pubis is a condition which predominantly affects young athletes. However, it may also occur following uro-gynecological interventions. We report a case of osteitis pubis following laparoscopic Burch colposuspension. There are several theories on the pathogenesis of postoperative osteitis pubis and a wide variety of treatment options have shown inconsistent outcomes. In our case, the condition was diagnosed radiologically and was managed with antibiotics and analgesics, which resulted in complete recovery.

Childbirth Experience Questionnaire (CEQ) in the Sri Lankan setting: translation, cultural adaptation and validation into the Sinhala language.

OBJECTIVE: To adapt the CEQ into Sri Lankan Sinhala cultural context and to determine the psychometric properties of CEQ. This would yield an opportunity to evaluate childbirth experience among Lankan population. RESULTS: Out of 390, 226 (57.9%) postnatal mothers completed the CEQ after 1 month postpartum. Face validity and content validity were demonstrated with all participants stating that CEQ was easy to understand and complete. For reliability, internal consistency was acceptable for the overall score (0.85) and for all four domains in CEQ (0.65, 0.80, 0.70, 0.83 for "own capacity", "professional support", "perceived safety" and "participation", respectively). A weighted kappa of 0.61-0.80 for all 22 items in CEQ demonstrated a good test-retest reliability. This Sri Lankan version showed fit statistics in line with standard recommendations in exploratory factor analysis. Women with spontaneous onset of labour (except for "professional support" in women with spontaneous onset of labour) and women with a normal birth showed significantly higher CEQ scores. However, oxytocin augmentation could not yield a difference in CEQ scores.

Hyperglycaemia in Pregnancy and Anthropometric Parameters in the Offspring at 10 Years: A Community-Based Retrospective Cohort Study in Sri Lanka.

Background: Studies of developmental origins of health and disease have highlighted the possible role of intrauterine hyperglycaemia, increasing the future risk of obesity, diabetes, and cardiovascular diseases in the offspring. There is limited evidence from South Asian populations for risk estimates for childhood obesity that are attributable to maternal diabetes in utero. Objective: The aim of this study was to determine the association between hyperglycaemia in pregnancy (HIP) and anthropometric parameters in the offspring at 10-11 years of age. Methods: A community-based retrospective cohort study was conducted in Colombo district, Sri Lanka. In the first stage, children born in 2005 were identified, and the availability of antenatal records was assessed. In the second stage, the exposure status of participants was ascertained based on antenatal records and predefined criteria. In the third stage, height, weight, waist circumference, and triceps skinfold thickness (TSFT) of eligible participants were measured to ascertain the outcome status. Background characteristics were collected by interviewing mothers. A 24-hour dietary recall and a 3-day diet diary were recorded. Results: 159 children of mothers with HIP (exposed) and 253 children of mothers with no HIP (nonexposed) participated. Mean ages (SD) of exposed and unexposed groups were 10.9 (0.3) and 10.8 (0.3) years, respectively. The median BMI (17.6 vs 16.1, p < 0.001), waist circumference (63 cm vs 59.3 cm, p < 0.001), and triceps skinfold thickness (13.7 mm vs 11.2 mm, p < 0.001) were significantly higher in the exposed group. Offspring of women with HIP were more likely to be overweight (aOR = 2.6, 95% CI 1.4-4.9) and have abdominal obesity (aOR = 2.7, 95% CI 1.1-6.5) and high TSFT (aOR = 2.2, 95% CI 1.06-4.7) at 10-11 years than children who were not exposed after adjusting for maternal BMI, maternal age at delivery, and birth order. Conclusions: Intrauterine exposure to HIP is a significant determinant of overweight, high TSFT, and abdominal obesity in the offspring.

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.

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.

Gestational diabetes mellitus and risk of type 2 diabetes 10 years after the index pregnancy in Sri Lankan women-A community based retrospective cohort study.

BACKGROUND: Women with a history of gestational diabetes mellitus (GDM) have an increased risk of type 2 diabetes mellitus (T2DM) later in life compared to women with no GDM. This study was aimed to determine the risk of developing T2DM 10 years after GDM in Sri Lankan women. METHODS: A retrospective cohort study was conducted in the Colombo district, Sri Lanka. 7205 women who delivered a child in 2005 were identified through Public Health Midwives in the field. Women with antenatal records were interviewed and relevant data were extracted from medical records to identify potential participants. One hundred and nineteen women who had GDM and 240 women who did not have GDM were recruited. Current diagnosis of diabetes was based on history, relevant medical records and blood reports within the past 1 year. RESULTS: The mean duration of follow up was 10.9 (SD = 0.35) years in the GDM group and 10.8 (SD = 0.31) years in the non-GDM group. The incidence density of diabetes in the GDM group was 56.3 per 1000 person years compared to 5.4 per 1000 person years in non GDM group giving a rate ratio of 10.42 (95% CI: 6.01-19.12). A woman having GDM in the index pregnancy was 10.6 times more likely to develop diabetes within 10 years compared to women with no GDM after controlling for other confounding variables. Delivering a child after 30 years, being treated with insulin during the pregnancy and delivering a baby weighing more than 3.5 Kg were significant predictors of development of T2DM after controlling for family history of diabetes mellitus (DM), GDM in previous pregnancies, parity and gestational age at delivery. CONCLUSIONS: Women with GDM had a 10-fold higher risk of developing T2DM during a 10-year follow up period as compared to women with no GDM after controlling for other confounding variables.

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.

Toxoplasmosis awareness, seroprevalence and risk behavior among pregnant women in the Gampaha district, Sri Lanka.

BACKGROUND: Primary gestational toxoplasmosis can be transmitted to the fetus with deleterious effects on the pregnancy. There is very little information regarding gestational toxoplasmosis in Sri Lanka. This survey was done to determine the prevalence and awareness of toxoplasmosis and to identify risk factors of infection among pregnant women in the Gampaha district, Sri Lanka. METHODS: Women attending obstetric clinics at the Colombo North Teaching Hospital in 2014 were tested for Toxoplasma gondii (T. gondii) specific Immunoglobulins G (IgG) and M (IgM) subtypes using the OnSite Toxo IgG/IgM Rapid Test-Dip Strip(®). Disease awareness and risk behaviors of the participants were investigated. RESULTS: Of the 293 participants (mean age 27 years, SD ± 5.92), 38% were primigravidae with a mean gestational age of 16.2 weeks (SD 7). The prevalence of anti-T. gondii IgG and IgM antibodies was 12.3% (n = 36) and zero, respectively. Unadjusted and adjusted odds ratios were calculated to determine risk factors of infection (cat-ownership, handling cats, consumption of meat, commercial meals and unwashed raw vegetables and fruits, handling soil and not washing hands after handling soil). On bivariate analysis, eating commercially prepared meals weekly or more was associated with toxoplasma seroprevalence with marginal statistical significance. On multivariate analysis, none of the considered risk factors were significant. Toxoplasma awareness was 4.4% (n = 13); health personnel (46.2%, n = 6) and media (53.8%, n = 7) being sources of information. CONCLUSIONS: Health education programs to increase awareness of toxoplasmosis is recommended at antenatal clinics.

Diagnostic and therapeutic dilemmas of cervical ectopic pregnancy.

IMPORTANCE: Cervical pregnancy is a rare variety of ectopic pregnancy. The etiology is obscure. Its diagnosis may be difficult, and its management has enormously changed during the last 10 years. Unfortunately, the most effective, fertility-sparing treatment is still unclear until now. OBJECTIVES: The aim of this study was to explore the safety and efficacy of different treatment modalities of cervical pregnancy. EVIDENCE ACQUISITION: A comprehensive systematic review of the literature was performed using the electronic databases MEDLINE and PubMed, using key words cervical, ectopic, and pregnancy, between January 2005 and June 2013. We included all case reports and case series reporting on cervical ectopic pregnancy. RESULTS: A total of 252 cases of cervical ectopic pregnancy were analyzed. Eighty-eight cases (34.9%) had medical treatment, 69 cases (27.5%) had surgical treatment, and 95 cases (37.6%) had combined medical and surgical treatment. Various conservative treatment regimens have been introduced to preserve fertility in young women, with methotrexate being one of the most widely used and effective drugs. CONCLUSIONS AND RELEVANCE: A high index of suspicion, combined with meticulous review of clinical and radiological findings, is essential to make an accurate diagnosis of cervical pregnancy. The success of conservative treatment depends mainly on early diagnosis. Such cases would be best managed at specialist tertiary referral centers and preferably, where available, Early Pregnancy Assessment Units, whether medical, surgical, or combined treatment modalities were attempted.