Ethanol sclerotherapy for uterine myomas: A new therapeutic strategy

The aim of this study was to evaluate the safety, efficacy and outcome of ethanol sclerotherapy for uterine myomata. This is a series of 20 patients (aged 20 to 40 years) with symptomatic uterine myomata submitted to ethanol sclerotherapy. The procedure was performed under sedation and guided by transvaginal ultrasound. The patients were followed clinically and ultrasonically (transvaginal sonography and color Doppler evaluation) one month and six months after treatment. The frequency of symptoms, intratumoral color flow mapping and tumoral size were analyzed. Chi-square and Mann-Whitney tests were used at a 5% level of significance. Postprocedure complications were not observed. A significant relief of dysmenorrhea was observed with one and six months and the frequency of pelvic pain and menorrhagia was significantly reduced with six months. A significant reduction of tumoral size was observed, from 89,4 cm3 (inicial volume) to 73,5 cm3 e 69,9 cm3 (one and six months, respectively). The frequency of intratumoral high blood flow was 80% before and 15% and 20% one and six months after the procedure (p=0,0001). It can be concluded that these preliminary results indicate that transvaginal ultrasound-guided ethanol sclerotherapy can be an effective treatment for uterine myomas when conservative management is preferable. Patient satisfaction was high and the procedure might become an accepted option for the treatment of uterine myomata.O estudo avaliou a segurança, eficácia e resultados da técnica de alcoolização para tratamento da miomatose uterina. Analisou-se uma série de 20 pacientes (idade variando entre 20 e 40 anos) submetidas a alcoolização para tratamento de miomatose uterina sintomática. O procedimento foi realizado sob anestesia geral, guiado por ultra-sonografia transvaginal. Realizou-se seguimento clínico e ultra-sonográfico (ultra-sonografia transvaginal e doppler colorido) com um e seis meses depois do tratamento. Analisaram-se os parâmetros: frequência de sintomas, mapa vascular (doppler) e tamanho da tumoração. Utilizaram-se os testes do qui-quadrado e Mann-Whitney. Significância p<0,05. Não ocorreram complicações depois do procedimento. Observou-se alívio significativo da dismenorréia com um e seis meses e a frequência de dor pélvica e hipermenorragia reduziu-se significativamente com seis meses. Encontrou-se ainda uma significativa redução do tamanho tumoral, de 89,3cm³ (volume inicial) para 73,5cm³ e 69,9cm³ (um e seis meses, respectivamente). A frequência de padrão de alto fluxo intra-tumroal foi de 80% antes e 15% e 20% um e seis meses depois do procedimento (p=0,0001). Conclui-se que estes resultados preliminares indicam que a alcoolização guiada por ultra-sonografia pode constituir uma opção terapêutica efetiva para o tratamento conservador de pacientes com miomas uterinos. O grau de satisfação das pacientes foi elevado e o procedimento pode vir a se tornar uma opção aceita para o tratamento da miomatose uterina.313

Prospective observational cohort study on grading the severity of postoperative complications in global surgery research

Background The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs). Methods This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs. Results A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59). Conclusion Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

© 2017 British Journal of Anaesthesia Background: The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Methods: Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. Results: We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32–0.77); P\u3c0.01], but no difference in complication rates [OR 1.02 (0.88–1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62–0.92); P\u3c0.01; I2=87%] and reduced complication rates [OR 0.73 (0.61–0.88); P\u3c0.01; I2=89%). Conclusions: Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine

Critical care admission following elective surgery was not associated with survival benefit: prospective analysis of data from 27 countries

This was an investigator initiated study funded by Nestle Health Sciences through an unrestricted research grant, and by a National Institute for Health Research (UK) Professorship held by RP. The study was sponsored by Queen Mary University of London