Medicine
Permanent URI for this communityhttp://repository.kln.ac.lk/handle/123456789/12
This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
Browse
16 results
Search Results
Item Cut-off Scores for International Consultation on Incontinence Modular Questionnaire on Vaginal Symptoms (ICIQ-VS) in Sinhala and Tamil(Sri Lanka College of Obstetricians & Gynaecologists, 2017) Amarasekara, A.M.A.K.G.; Ekanayake, C.D.; Pathmeswaran, A.; Wijesinghe, P.S.; Liyanage, L.L.C.; Kulasinghe, I.R.M.M.; Perera, H.S.S.INTRODUCTION: It is clinically beneficial to have cut-off scores for screening questionnaires, above which a patient can be referred for further evaluation at a specialist center especially in developing countries. OBJECTIVE: To calculate cut off scores for ICIQ-VS-Sinhala and ICIQ-VS- Tamil questionnaires. METHODS: The ICIQ-VS- Sinhala and ICIQ-VS-Tamil was administered to women attending the gynaecology clinics at North Colombo teaching hospital, Ragama, District General hospitals, Mannar and Vavuniya. The vaginal symptoms score (VSS), sexual symptoms score (SSS) and the quality of life score (QoL) were analysed against the clinician’s diagnosis of significant prolapse using receiver operating characteristic curves (ROC). Results: The AUC (area under curve) for ROC curves of VSS, SSS and QoL for ICIQ-VS-Sinhala were 0.89 (p<0.001), 0.64 (p<0.02) and 0.75 (p<0.001) respectively. The AUC for ROC curves VSS, SSS and QoL of ICIQ-VS-Tamil were 0.88 (p<0.001), 0.70 (p<0.02) and 0.82 (p<0.001) respectively. The optimal MCIDs for ICIQ-VS-Sinhala were VSS ≥≥ 8 (sensitivity 88.1%, specificity 73.9%), SSS ≥ 1 (sensitivity 59%, specificity 65%), QoL ≥ 3 (sensitivity 77.8%, specificity 60.4%) while for ICIQ-VS-Tamil VSS ≥ 9 (sensitivity 87.1%, specificity 80.9%), SSS ≥ 1 (sensitivity 76.5%, specificity 61.1%) and QoL ≥3 (sensitivity 77.8%, specificity 79.8%). CONCLUSION: Both questionnaires yielded promising cut off scores for VSS, SSS and QoL. Cut-off scores of VSS ≥9, SSS ≥1 and QoL≥3 for ICIQ-VS-Tamil and VSS ≥8, SSS ≥1 and QoL ≥3 for ICIQ-VS-Sinhala can be used as a guide for specialist referral when using ICIQ-VS to screen for pelvic floor dysfunction in Sri Lanka.Item Translation and Validation of ICIQ-FLUTS for Tamil speaking Women(Sri Lanka College of Obstetricians & Gynaecologists, 2017) Pieris, T.R.; Ekanayake, C.D.; Basith, F.D.A.; Wickramaratna, D.K.U.; Peries, E.E.; Antonythas, R.; Pathmeswaran, A.; Wijesinghe, P.S.OBJECTIVES: Research in to lower urinary tract symptoms in South Asia is hampered by lack of validated tools. There fore ouraimwas to validate the International Consultation onIncontinencemodular questionnaire on female lower urinary tracts ymptoms (ICIQ-FLUTS) from English toTamil. METHODS: The ICIQ-FLUTS was translated to Tamil and a validation study was carried out among women attending the gynaecology clinic at district general hospital-Mannar. RESULTS: Content validity assessed by the level of missing data was less than 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 SD=4.7, controls=1.4 SD=2.2, p<0.001) andthose with symptomatic anterior wall prolapse (n=16) fromcontrols (n=93) using the voiding symptoms score (patients=4.8SD=2.3, controls=0.3 SD=0.8, p<0.001). Internal consistency was assessed using Cronbach’scoefficient alpha score (0.80 (0.77-0.81). Test–retest reliability assessed by weighted kappa (k) ranged from 0.73to0.87. Patients with incontinence (n=30, pre-treatment incontinence score=7.9, SD=4.9 versus post-treatment incontinence score=3.3, SD=3.1) and symptomatic anterior wall prolapse (n=14, pre-operative voiding symptoms score=4.9 SD=2.5 versus post-operative voiding symptoms score=0.9 SD=1.5) showed an improvement with treatment (Wilcoxon matched –pairs signedranktestp<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: The Tamil translation of ICIQ-FLUTS has retained the psychometric properties of the original English questionnaire and will be an invaluable tool to elicit LUTS among Tamil speaking women.Item Cost-effectiveness of three routes of hysterectomy: a multi-centre randomized controlled trial(Sri Lanka College of Obstetricians & Gynaecologists, 2018) Ekanayake, C.D.; Pathmeswaran, A.; Kularatna, S.; Herath, R.P.; Wijesinghe, P.S.BACKGROUND: Hysterectomy is the commonest major gynaecological surgical procedure. The aim of this study was to evaluate the cost-effectiveness of non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH) compared to total abdominal hysterectomy (TAH). METHODS: A randomized controlled trial was conducted at the gynaecology unit, District General Hospital, Mannar and professorial gynaecology unit, North Colombo Teaching Hospital, Ragama. Study population (n=49 per arm) were women needing hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus 14 weeks, previous pelvic surgery, those requiring incontinence/pelvic floor surgery, comorbidities which preclude laparoscopic surgery and women who were illiterate. Primary outcome was the time to recover following hysterectomy which was considered as the earliest time to resume activities done prior to surgery. A Kaplan-Meier survival analysis was done with pairwise comparison through log-rank test for the primary outcome. A micro-costing approach calculated utilization of hospital resources from the time of presentation up to six months after surgery. Incremental costeffectiveness ratios (ICER) were obtained by calculating the incremental costs divided by the incremental effects (time to recover) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. RESULTS: The overall combined results from both centres did not show a significant difference in time to recover (median, 95% confidence interval) between TLH [30 days (29.0-31.0)], NDVH [32 days, (28.3-35.7)] and TAH [35 days (32.0-38.0)] (Kruskal-Wallis test, p=0.373). There was a significant difference in direct cost (median, inter quartile range) between TAH [Rs.41943, (38256-44476)] versus TLH [50608 (46670-54859)], Mann-Whitney U test, p<0.001, NDVH [Rs.40373 (3693244212) versus TLH, Mann-Whitney U test, p<0.001. There was no significant difference between TAH and NDVH, Mann-Whitney U test, p=0.076. ICERTLH-TAH was Rs. 1733/ day compared to TAH. ICERNDVH-TAH was not calculated as both the cost and effect were more favourable than TAH. ICERTLH-NDVH was Rs.3412/day compared to NDVH. CONCLUSIONS: There was no significant difference in time to recover between TLH, NDVH and TAH. The optimum approach to hysterectomy appears to be NDVH in terms of costeffectiveness due to its lower cost, a fact that was suggested from the interim analysis presented at SLCOG sessions in 2017.Item Challenges of costing a surgical procedure: a case study on hysterectomy(Sri Lanka College of Obstetricians & Gynaecologists, 2018) Ranasinghe, S.W.; Liyanage, L.; Peiris, R.; Bandaranayake, H.; Ekanayake, C.D.; Pathmeswaran, A.; Kularatna, S.; Wijesinghe, P.S.INTRODUCTION: It is vital to enquire in to cost of healthcare to ensure that maximum value for money is obtained with available resources. However, there is a dearth of information on cost of healthcare in lower-middle income countries. Our aim was to study the costs for three routes of hysterectomy in benign uterine conditions; total abdominal (TAH), non-descent vaginal (NDVH) and total laparoscopic hysterectomy (TLH). METHOD: A societal perspective with a micro-costing approach was applied to find out direct and indirect costs. Patients were recruited from a district general hospital (Mannar) and an urban tertiary care hospital (Ragama). The total cost incurred during pre-operative, operative, post-operative periods and convalescence included direct costs of labour, equipment, investigations, medications and utilities. Indirect costs included of out-of-pocket expenses, productivity losses, carer costs and travelling. Time-driven activity-based costing was used for labour costs and top down micro-costing was used for utilities. RESULTS: The median direct cost [(interquartile range), number] of TAH was Rs. 43054 [(41604 - 46243), n=24] versus Rs. 39430 [(37690 - 43054), n=25] (Mann-Whitney U test, p<0.01), NDVH was Rs. 40590 [(36965 - 44793), n=23] versus Rs.40155 [(36676 - 43779), n=26] (Mann-Whitney U test, p=0.984) and TLH was Rs. 47258 [(44359 - 51897), n=24] versus Rs. 53056 [(48128 - 55811), n=25] (Mann-Whitney U test, p=0.16) at Mannar and Ragama respectively. The median indirect cost (interquartile range) of TAH was Rs. 4204 (2174 12757) versus Rs. 9857 (5219 - 17251) (Mann-Whitney U test, p<0.05), NDVH was Rs.4349 (2174 - 8263) versus Rs. 10872 (5943 - 34646) (Mann-Whitney U test, p<0.01) and TLH was Rs. 6668 (2754 - 12902) versus Rs. 7538 (4929 - 21454) (MannWhitney U test, p=0.28) at Mannar and Ragama respectively. Sensitivity analysis using the best case scenario and a minimum wage of Rs. 1500 per day till time to recovery for TAH, NDVH and TLH showed a total cost of Rs. 87557, 78715 and 79150 respectively. CONCLUSION: Time-driven activity-based costing for labour and top down micro-costing of utilities helped to overcome logistical difficulties. Indirect costs at Ragama were significantly more than that at Mannar. Sensitivity analysis adjusted for the best case scenario and minimum wage suggested that NDVH and TLH may in fact be cheaper than TAH. The costing method used in this study is a simple and reproducible way of calculating costs of a surgical procedure which will serve as a guide for clinicians and policy makers in similar settings.Item Cost-effectiveness of TLH versus NDVH versus TAH: a multi-centre randomized controlled trial.(Sri Lanka College of Obstetricians & Gynaecologists, 2018) Ekanayake, C.D.; Pathmeswaran, A.; Pieris, R.; Wijesinghe, P.S.OBJECTIVE: Hysterectomy is the commonest major gynaecological surgical procedure. There are many approaches in performing a hysterectomy which depend on clinical criteria. However certain patients are suitable to be operated through any approach. The objective of this study was to provide evidence on the optimal approach in terms of cost-effectiveness between non-descent vaginal hysterectomy (NDVH), total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH). METHODS: A multi-centre three arm randomized controlled trial is being conducted at the professorial gynaecology unit, North Colombo Teaching Hospital, Ragama and gynaecology unit, District General Hospital, Mannar. Results of the Mannar arm are presented. Study population were women needing hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus 14 weeks, previous pelvic surgery, those requiring incontinence/pelvic floor surgery, co-morbidities which precludes laparoscopic surgery and women who are illiterate. Primary outcome was time taken to resume all activities done prior to surgery. A micro-costing approach was adopted to calculate utilization of hospital resources from the time of presentation to the gynaecology clinic up to six months after surgery. The treatment groups were compared using a one-way analysis of variance (ANOVA) followed by Tukey's HSD for post hoc comparisons of the mean values. Incremental cost-effectiveness ratios (ICER) were obtained by calculating the incremental costs divided by the incremental effects (time to recover) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. RESULTS: There was a significant difference in time to recover in TLH [28.9 days (26.2-31.2), p<0.02] and NDVH [29.8 days (26.8-32.9), p<0.05] versus TAH [35.5 days (32.0-39.0)]. There was no significant difference between TAH and NDVH [p=0.90].The direct cost of a TLH [Rs. 45371 (43770-46972)] was significantly more than TAH [Rs. 34060 (32521-35599), p<0.001] or NDVH [Rs. 33038 (29720-36356), p<0.001]. There was no significant difference between TAH and NDVH (p=0.81). The incremental costs of a TLH was significantly more than TAH [Rs.11311 (9710 to 12912), p<0.001]. The incremental cost of a NDVH was [Rs. 1022(-4340 to 2296), p=0.81) less than TAH. ICER-TLH was Rs.1714/day. As both the cost as well as the time to recover was more favourable than TAH, ICER-NDVH was not calculated. CONCLUSION: This interim analysis shows that TLH and NDVH have a faster recovery compared to TAH. However, the incremental costs for a TLH were considerably higher. The optimum approach to hysterectomy appears to be NDVH in terms of cost-effectivenessItem A Possible progression of an atypical leiomyoma to a leiomyosarcoma(Sri Lanka College of Obstetricians & Gynaecologists, 2016) Ekanayake, C.D.; Liyanage, A K.; Herath, R.P.; Fernando, W.S.; Mahendra, B.A.G.G.BACKGROUND: The spectrum of uterine smooth muscle cell tumours can range from leiomyoma to leiomyosarcoma. Atypical leiomyomasare a group of tumours with cellular atypia and a mitotic indexof up to 5/HPF that are classified between the innocuous leiomyoma and leiomyosarcomas. The absence of coagulative necrosis helps to differentiate it from leiomyosarcomas.Traditionally atypical leiomyomas are thought to have a low recurrence rate. CASE DETAILS: A 41-year-old woman underwent a myomectomy for ananteriorcervical fibroid.Histology revealed a smooth muscle tumour (SMT) withdiffusely scattered hyperchromatic large cells. The maximum mitotic count was 5/10 HPF.There was no coagulative necrosis or atypical mitotic figures. It was classified as an atypical leiomyomas and had close follow up. However, 30 months later she developed heavy menstrual bleeding. The ultrasound scan revealed an anterior fibroid. She underwent a total abdominal hysterectomy with ovarian conservation. The specimen showed a well-defined myometrial nodule of 7cm with haemorrhagic areas,compressing the cervix. It was a SMT with high a mitotic activity (11-12/HPF), atypical cells with bizarre nuclei and focal coagulative necrosis confirming a leiomyosarcoma (FIGO 1B). CONCLUSION: As atypical leiomyomashave a low risk profile and are mostly found in younger women,it invariably leads to treatment that offers fertility preservation. This case challenges the generalisability of this currently held viewpoint and recommends more extensive surgery or further heightened surveillanceItem Translation and validation of generic questionnaire on lower urinary tract symptoms for females (ICIQ-FLUTS) inTamil language(Sri Lanka College of Obstetricians & Gynaecologists, 2016) Ekanayake, C.D.; Wijesinghe, P.S.; Pathmeswaran, A.; Abdul Basith, F.D.; Srikrishnan, K.; Wickramaratna, D.K.U.OBJECTIVE: Lower urinary tract symptomsare often underreported by women. Therefore, we wanted to translate and validate the International Consultation on Incontinence Modular Questionnaire on female lower urinary tract symptoms (ICIQ FLUTS) from English to Tamil language. METHODS: With permission, the ICIQ-FLUTS questionnaire was translated to Tamil using the standard procedure. A validation study was carried out among women attending the gynaecology clinicat district general hospital-Mannar. RESULTS: Basic characteristics were as follows; patients with incontinence (n=33) age 50.8 (SD 14.8),median parity=3 (IQ11Q3=2-4), BMI 25.8 kg/m2 (SD 5.2), patients with voiding symptoms (n=15) age 60.6 (SD 11.6), median parity=4(IQ11Q3=3-4), BMI 24.8 kg/m2 (SD 3.5) and controls (n=74) age 42.8 (SD 15.1), median parity=2 (IQ1-1Q3=1-3), BMI 25.4 kg/m2 (SD 4.4).Content validityassessed by the level of missing data was less than 3% for each item.For the internal consistency,Cronbach’s coefficient alpha scores ranged from 0.79-0.83. Kappa values for test–retest reliabilityin all items were 0.56 to 0.79. Construct validity was assessed by the ability of the questionnaire to identify patients with incontinence from controls (p<0.001) and those with voiding symptoms from controls (p<0.001).Patients with incontinence (n=10)and voiding symptoms (n=9)showed an improvement with treatment (Wilcoxon matched –pairs signedrank test p<0.01 and p<0.05 respectively). CONCLUSIONS: The preliminary results of the Tamil validation of the ICIQ FLUTS are satisfactory and once completed it will be invaluable to elicit female lower urinary tract symptoms in Tamil speaking patients.Item Validation of the Sinhala translation of the International Consultation on Incontinence modular Questionnaire on Vaginal Symptoms (ICIQ-VS)(Sri Lanka College of Obstetricians & Gynaecologists, 2016) Ekanayake, C.D.; Patabendige, M.; Wijesinghe, P.S.; Pathmeswaran, A.; Herath, R.P.; Weerasinghe, N.OBJECTIVE: To translate and validate the International Consultation on Incontinence Modular Questionnaire on vaginal symptoms (ICIQ VS) from English to Sinhala.METHODS: ICIQ-VS questionnaire was translated to Sinhala and a validation study was carried out among women attending the gynaecology clinic at North Colombo teaching hospital, Ragama. RESULTS: Basic demographic characteristics of women with prolapse (n=64) versus women without prolapse (n=135) were as follows; Age 55.8 (SD 13.1) years, median parity 2.5 (IQ1IQ3=2-4), BMI 23.8 kg/m2 (SD 3.2) versus age 42.6 (SD 13.1), median parity 2 (IQ1-IQ3=1-3), BMI 23.2 kg/m2 (SD 2.9) respectively. Content validity was assessed by the level of missing data which was less than 1% for each item. Internal consistency was assessed using Cronbach’s coefficient alpha scores which ranged from 0.75 to 0.78. Test–retest reliability as assessed by kappa values ranged from 0.54 to 0.80, except for item, ‘vagina too tight’ which demonstrated moderate reliability (kappa 0.41). Construct validity was assessed by the ability of the questionnaire to differentiate between patients and controls. The questionnaire differentiated between patients and controls on vaginal symptoms score (VSS) (p<0.001), sexual symptoms score (SSS) (p<0.05) and quality of life (p<0.001). There was a positive correlation between pelvic organ prolapse quantification system (POP-Q) scores and VSS (rs= 0.61, p<0.001), SSS (rs = 0.22, p<0.01) and quality of life (rs = 0.52, p<0.001). CONCLUSIONS: The preliminary results for ICIQ VS (Sinhala) validation are satisfactory and once completed it will be invaluable to objectively assess vaginal and sexual symptoms in Sinhala speaking population in Sri LankaItem Validation of the Tamil translation of the International Consultation on Incontinence modular Questionnaire on Vaginal Symptoms (ICIQ-VS)(Sri Lanka College of Obstetricians & Gynaecologists, 2016) Ekanayake, C.D.; Wijesinghe, P.S.; Pathmeswaran, A.; Samaranayake, K.U.; Herath, C.; Nishad, A.A.N.OBJECTIVES: To translate and validatethe International Consultation on Incontinence Modular Questionnaire on vaginal symptoms (ICIQ VS) from English to Tamil. METHOD: With permission, ICIQ-VS questionnaire was translated to Tamil and a validation study was done on women attending the gynaecology clinics at district general hospitals, Mannar and Vavuniya. RESULTS: The basic characteristics of women with prolapse (n=63) versus women without prolapse (n=83) were as follows; age 60.68 (SD 11.64), median parity=4 (IQ1-IQ3=3-5), BMI 23.90 kg/m2 (SD 3.36) versus age 40.49 (SD 12.54), median parity=2(IQ1IQ3=1-3), BMI 25.84 kg/m2 (SD 4.84) respectively. Content validity was assessed by the level of missing data which was less than 3% for each item. Internal consistency as assessed by Cronbach’s coefficient alpha score was 0.83 (0.80-0.84). Kappa values for test–retest reliability of individual items ranged from0.59 to 0.74. The questionnaire differentiated between patients and controls in vaginal symptoms score(VSS) (P<0.001), sexual symptoms score(SSS) (p<0.05) and quality of life p<0.001). There was a positive correlation between pelvic organ prolapse quantification system (POP-Q) scores and VSS (rs= 0.67, p<0.001), SSS (rs= 0.26p<0.05) and quality of life (rs = 0.62, p<0.001).Vaginal symptoms (n=24) and quality of life (n=21) showed an improvement following surgery(Wilcoxon matched– pairs signed-rank test p<0.001 and p<0.001 respectively). CONCLUSION: The preliminary results for ICIQ VS (Tamil) validation are satisfactory and once completed it will be invaluable to objectively assess vaginal and sexual symptoms in Tamil speaking population in Sri LankaItem A possible progression of an atypical leiomyoma to a leiomyosarcoma(Sri Lanka College of Obstetricians & Gynaecologists, 2016) Ekanayake, C.D.; Liyanage, A.K.; Herath, R.P.; Fernando, W.S.; Mahendra, B.A.G.G.BACKGROUND: The spectrum of uterine smooth muscle cell tumours can range from leiomyoma to leiomyosarcoma. Atypical leiomyomasare a group of tumours with cellular atypia and a mitotic indexof up to 5/HPF that are classified between the innocuous leiomyoma and leiomyosarcomas. The absence of coagulative necrosis helps to differentiate it from leiomyosarcomas.Traditionally atypical leiomyomas are thought to have a low recurrence rate. CASE DETAILS: A 41-year-old woman underwent a myomectomy for ananteriorcervical fibroid.Histology revealed a smooth muscle tumour (SMT) withdiffusely scattered hyperchromatic large cells. The maximum mitotic count was 5/10 HPF.There was no coagulative necrosis or atypical mitotic figures. It was classified as an atypical leiomyomas and had close follow up. However, 30 months later she developed heavy menstrual bleeding. The ultrasound scan revealed an anterior fibroid. She underwent a total abdominal hysterectomy with ovarian conservation. The specimen showed a well-defined myometrial nodule of 7cm with haemorrhagic areas,compressing the cervix. It was a SMT with high a mitotic activity (11-12/HPF), atypical cells with bizarre nuclei and focal coagulative necrosis confirming a leiomyosarcoma (FIGO 1B). CONCLUSION: As atypical leiomyomashave a low risk profile and are mostly found in younger women,it invariably leads to treatment that offers fertility preservation. This case challenges the generalisability of this currently held viewpoint and recommends more extensive surgery or further heightened surveillance.