Optimal antiseptic skin preparation agents for minimizing surgical site infection following surgery: cost and cost-effectiveness analysis.

BACKGROUND: The application of antiseptic skin agents prior to incision minimizes the rate of surgical site infection. Despite their ubiquity, the optimal skin preparation agent remains uncertain. A retrospective economic analysis was conducted to complement the results from the NEWSkin Prep trial which prospectively compared three preparation agents. METHODS: A cost and cost-effectiveness analysis was performed from a healthcare service perspective to compare chlorhexidine with 70% ethanol, and aqueous povidone-iodine, against povidone-iodine with 70% ethanol. Resource use estimates accounted for hospital admissions, readmissions associated with surgical site infection, outpatient and general practitioner attendances, visits from community nurses and therapeutic consumables. The measure of effectiveness comprised the net difference in number of patients with surgical site infections per 1000 patients. Costs were compared using a two-sample Welch's t-test. Deterministic and probabilistic sensitivity analyses were performed to evaluate the incremental cost-effectiveness ratio. RESULTS: The null hypothesis that the mean costs for the trial arms were significantly different was not rejected (Welch's t-test P value: 0.771 for chlorhexidine with 70% ethanol against povidone-iodine with 70% ethanol; and 0.955 for aqueous povidone-iodine against povidone-iodine with 70% ethanol). Based on bootstrap averages, the chlorhexidine with 70% ethanol intervention generated 8.0 fewer surgical site infections per 1000 patients and net cost savings of €151,698 (Euros) per 1000 patients compared with povidone-iodine with 70% ethanol, and aqueous povidone-iodine produced a net cost saving of €37,494 per 1000 patients but generated an additional 11.6 surgical site infections per 1000 patients compared with povidone-iodine with 70% ethanol. The comparison of chlorhexidine with 70% ethanol to povidone-iodine with 70% ethanol was sensitive to the inclusion of cost outliers, while the comparison of aqueous povidone-iodine to povidone-iodine with 70% ethanol was sensitive to the estimated cost per surgical site infection. CONCLUSION: Based on the outcomes from the NEWSkin Prep study, this economic analysis found no definitive evidence in favour of any one of the study comparators. Future model-based economic analyses of alternative skin preparations should critically address the quality of evidence and integrate the results from the NEWSkin Prep study.

Antiseptic Skin Agents to Prevent Surgical Site Infection After Clean Implant Surgery: Subgroup Analysis of the NEWSkin Prep Trial.

Background: There remains debate as to the ideal skin preparation agent to prevent surgical site infection (SSI) after clean implant surgery. This study is a subgroup analysis of all patients undergoing implant surgery in the NEWSkin prep trial. Patients and Methods: The NEWSkin prep trial is a randomized clinical trial (RCT; n = 3300) comparing the three antiseptic skin preparation agents commonly used prior to incisional surgery: chlorhexidine with alcohol (C-Alc), povidone iodine with alcohol (PI-Alc), and aqueous povidone iodine (PI-Aq). All participants who underwent clean incisional surgeries with implants from this trial were selected for analysis. The primary outcome was SSI rate; secondary outcomes were complication rates and re-admission rates. Results: A total of 712 patients in the NEWSkinPrep study underwent clean implant surgery between January 2015 and December 2018. Randomization resulted in the following distribution: C-Alc, 238; PI-Alc, 243; and PI-Aq, 231. Median age of participants was 63 years and 41% were female. Surgical site infection rates were: C-Alc, 10.13%; PI-Alc,11.52%; and PI-Aq, 11.26%. Povidone iodine with alcohol did not appear to be non-inferior to C-Alc (mean difference, 1.39%; 95% confidence interval [CI], -4.17 to 6.95) and PI-Alc was not superior to PI-Aq (mean difference, 0.27%; 95% CI, -5.45 to 5.99; p = 0.9271). There were no differences seen in secondary outcomes between groups. Conclusions: These results indicate a similarity between PI-Alc and C-Alc and that PI-Alc was not superior to PI-Aq. Because this study was not powered to assess these differences in clean cases with implants, additional studies are needed to assess these agents.

Venous thromboembolic prophylaxis: current practice of surgeons in Australia and New Zealand for major abdominal surgery.

BACKGROUND: Surgical prophylaxis for venous thrombo-embolic disease (VTE) includes risk assessment, chemical prophylaxis and mechanical prophylaxis (graduated compression stockings [GCS] and/or intermittent pneumatic compression devices [IPCD]). Although there is overwhelming evidence for the need and efficacy of VTE prophylaxis in patients at risk, only about a third of those who are at risk of VTE receive appropriate prophylaxis. OBJECTIVE: There is debate as to the best combination of VTE prophylaxis following abdominal surgery due to lack of evidence. The aim of this survey was to understand this gap between knowledge and practice. METHODS: In 2019 and 2020, a survey was conducted to investigate the current practice of venous thromboembolism (VTE) prophylaxis for major abdominal surgery, with a focus on colorectal resections. The study received ethics approval and involved distributing an 11-item questionnaire to members of two professional surgical societies: the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) and the General Surgeons Australia (GSA). RESULTS: From 214 surgeons: 100% use chemical prophylaxis, 68% do not use a risk assessment tool, 27% do not vary practice according to patient risk factors while > 90% use all three forms of VTE prophylaxis at some stage of treatment. Most surgeons do not vary practice between laparoscopic and open colectomy/major abdominal surgery and only 33% prescribe post-discharge chemical prophylaxis. 42% of surgeons surveyed had equipoise for a clinical trial on the use of IPCDs and the vast majority (> 95%) feel that IPCDs should provide at least a 2% improvement in VTE event rate in order to justify their routine use. CONCLUSION: Most surgeons in Australia and New Zealand do not use risk assessment tools and use all three forms of prophylaxis regardless. Therfore there is a gap between practice and VTE prophylaxis for the use of mechanical prophylaxis options. Further research is required to determine whether dual modality mechanical prophylaxis is incrementally efficacious. Trial Registration- Not Applicable.

A pilot study: intraoperative 16S rRNA sequencing versus culture in predicting colorectal incisional surgical site infection.

BACKGROUND: Surgical Site Infection (SSI) of the abdominal incision is a dreaded complication following colorectal surgery. Identifying the intraoperative surgical site microbes may provide clarity in the pathogenesis of SSIs. Genomic sequencing has revolutionized the ability to identify microbes from clinical samples. Utilization of 16S rRNA amplicon sequencing to characterize the intraoperative surgical site may provide the critical information required to predict and prevent infection in colorectal surgery. METHODS: This is a pilot, prospective observational study of 50 patients undergoing elective colorectal resection. At completion of surgery, prior to skin closure, swabs were taken from the subcutaneous tissue of the abdominal incision to investigate the microbial profile. Dual swabs were taken to compare standard culture technique and 16S rRNA sequencing to establish if a microbial profile was associated with postoperative SSI. RESULTS: 8/50 patients developed an SSI, which was more likely in those undergoing open surgery (5/15 33.3% versus 3/35, 8.6%; P = 0.029). 16S rRNA amplicon sequencing was more sensitive in microbial detection compared to traditional culture. Both culture and 16S rRNA demonstrated contamination of the surgical site, predominantly with anaerobes. Culture was not statistically predictive of infection. 16S rRNA amplicon sequencing was not statistically predictive of infection, however, it demonstrated patients with an SSI had an increased biodiversity (not significant) and a greater relative abundance (not significant) of pathogens such as Bacteroidacaea and Enterobacteriaceae within the intraoperative site. CONCLUSIONS: 16S rRNA amplicon sequencing has demonstrated a potential difference in the intraoperative microbial profile of those that develop an infection. These findings require validation through powered experiments to determine the overall clinical significance.

Topical Lidocaine or Lidocaine/Diltiazem Ointment Following Rubber Band Ligation of Hemorrhoids: A Prospective 3-Armed Randomized Controlled Trial.

BACKGROUND: Rubber band ligation of hemorrhoids causes less pain than excisional hemorrhoidectomy, but many patients still experience significant postprocedure discomfort. OBJECTIVE: This study aimed to determine whether topical lidocaine, with or without diltiazem, is more effective than placebo for analgesia after hemorrhoid banding. DESIGN: This is a prospective, randomized, double-blinded, placebo-controlled trial. Patients were randomly assigned to 2% lidocaine, 2% lidocaine with 2% diltiazem, or a placebo ointment. SETTINGS: This study was performed at 2 university public teaching hospitals and 2 private hospitals in Australia. PATIENTS: Consecutive patients aged ≥18 years undergoing hemorrhoid banding were selected. INTERVENTIONS: Topical ointments were applied postprocedure 3× daily for 5 days. MAIN OUTCOME MEASURES: Visual analog pain score, opiate analgesia usage, and patient satisfaction were the main outcome measures. RESULTS: Of 159 eligible patients, 99 were randomly assigned (33 in each group). Pain scores were reduced at 1 hour for the lidocaine (OR 4.15 [1.12-15.41]; p = 0.03) and lidocaine/diltiazem groups (OR 3.85 [1.05-14.11]; p = 0.04) compared with placebo. Patients in the lidocaine/diltiazem group had improved satisfaction (OR 3.82 [1.28-11.44]; p = 0.02) and were more likely to recommend the procedure to others (OR 9.33 [1.07-81.72]; p = 0.04). Patients in the lidocaine/diltiazem group required approximately 45% less total and in-hospital analgesia compared with the placebo. There was no difference in complications between any of the groups. LIMITATIONS: A cost/benefit analysis was not performed. Analgesic efficacy appeared to be short term and the procedures were performed only in the hospital/nonambulatory setting. CONCLUSIONS: Topical lidocaine reduced short-term analgesia use, whereas combination lidocaine/diltiazem was associated with both improved analgesia and patient satisfaction after hemorrhoid banding. LIDOCANA TPICA O UNGENTO DE LIDOCANA/DILTIAZEM DESPUS DE LA LIGADURA HEMORROIDAL CON BANDA ELSTICA UN ENSAYO PROSPECTIVO CONTROLADO Y ALEATORIZADO DE TRES BRAZOS: ANTECEDENTES:La ligadura de hemorroides con banda elástica causa menos dolor que la hemorroidectomía escisional, pero muchos pacientes siguen experimentando molestias significativas tras el procedimiento.OBJETIVO:Este estudio tiene como objetivo determinar si la lidocaína tópica, con o sin diltiazem, es más eficaz que el placebo para la analgesia tras la ligadura hemorroidal.DISEÑO:Este es un ensayo prospectivo, aleatorizado, doble ciego, controlado con placebo. Los pacientes fueron aleatorizados para recibir lidocaína al 2 %, lidocaína al 2 % con diltiazem al 2 % o ungüento de placebo.AJUSTES:Este estudio se realizó en dos hospitales públicos con docencia universitaria y dos hospitales privados en Australia.PACIENTES:Se seleccionaron pacientes consecutivos de ≥18 años sometidos a ligadura para hemorroides.INTERVENCIONES:Se aplicaron ungüentos tópicos tras el procedimiento tres veces al día durante 5 días.PRINCIPALES MEDIDAS DE RESULTADO:La puntuación analógica visual del dolor, el uso de analgésicos opiáceos y la satisfacción del paciente fueron las principales medidas de resultado.RESULTADOS:De 159 pacientes elegibles, 99 fueron aleatorizados (33 en cada grupo). Las puntuaciones de dolor se redujeron a la hora para los grupos de lidocaína (OR 4,15 (1,12-15,41); p = 0,03) y lidocaína/diltiazem (OR 3,85 (1,05-14,11), p = 0,04) en comparación con el placebo.Los pacientes del grupo de lidocaína/diltiazem mejoraron su satisfacción (OR 3,82 (1,28-11,44), p = 0,02) y eran más propensos de recomendar el procedimiento a otros (OR 9,33 (1,07-81,72), p = 0,04). Los pacientes del grupo de lidocaína/diltiazem requirieron aproximadamente un 45 % menos de analgesia total e intrahospitalaria en comparación con el grupo de placebo. No hubo diferencia en las complicaciones entre ninguno de los grupos.LIMITACIONES:No se realizó un análisis de costo/beneficio. La eficacia analgésica pareció ser a corto plazo y los procedimientos solo se realizaron en el hospital/entorno no ambulatorio.CONCLUSIÓN:La lidocaína tópica mejora la analgesia a corto plazo, mientras que la combinación de lidocaína/diltiazem se asocia tanto con una mejor analgesia como con la satisfacción del paciente tras la colocación de bandas para hemorroides. (Traducción-Dr Osvaldo Gauto ).

Prospective multicentre randomised controlled trial of the effect of Braun Enteroenterostomy in the Reconstruction after Pancreaticoduodenectomy on delayed gastric emptying (DGE): protocol for the BERP study.

INTRODUCTION: Despite advances in achieving low mortality rates with pancreaticoduodenectomy (PD), morbidity remains high. A key contributor to this morbidity is delayed gastric emptying (DGE) occurring with an incidence of up to 30%. The utility of a Braun enteroenterostomy (BE) appears promising to reducing the incidence of DGE, but current research is not definitive. METHODS AND ANALYSIS: This project will be designed as a prospective multicentre randomised controlled blinded study to assess how BE effects the rate of DGE after PD in the setting of malignancy, within Australia-with blinding of patients, outcome assessors and data analysts. Patients will be randomly assigned to PD with Billroth II reconstruction with BE versus PD with Billroth II reconstruction without BE. The primary outcome is the incidence of DGE as defined by the International Study Group of Pancreatic Surgery. Secondary outcomes will include length of hospital stay, postoperative pancreatic fistula incidence, development of major complications (Clavien-Dindo≥3 a), quality of life and 90-day mortality.The study will be powered at 80% to detect a reduction in DGE rate from 30% to 15%, requiring a total of 264 study participants. An interim analysis will be performed once a total of 104 study participants have been recruited at which point the study will be able to detect reduction in DGE from 30% to 10% with 80% power. Statistical analysis will be done with intention-to-treat principles. The proportion of patients suffering DGE will be compared between treatment arms using a χ2 test, with p values used to represent statistical significance. ETHICS AND DISSEMINATION: The study has been ethically approved by the Hunter New England Human Research Ethics Committee (2021/ETH11939), with results disseminated through presentation and publication. TRIAL REGISTRATION NUMBER: CTRN12622000048785.

Long-Term Health-Related Quality of Life Outcomes Following Thyroid Surgery for Malignant or Benign Disease: Deficits Persist in Cancer Survivors Beyond Five Years.

BACKGROUND: Thyroid cancer diagnoses are increasing and treatment can lead to significant morbidity. Long-term health-related quality of life (HRQoL) in thyroid cancer is understudied and lacks reference populations. This study compares long-term HRQoL between patients with thyroid cancer or benign disease, following thyroid surgery. METHODS: Patients undergoing thyroidectomy between 2000 and 2017 were identified from a pathology database. 696 participants (278 malignant, 418 benign) were invited to complete a validated disease-specific HRQoL tool, City of Hope-Thyroid Version. Propensity scores were used to adjust for demographic and clinical differences between cohorts. RESULTS: 206 patients (102 malignant, 104 benign), 71% female, returned surveys a median of 6.5 (range 1-19) years after thyroidectomy. Of the cancer cohort, 95% had differentiated thyroid cancer and 83% remained disease-free. There were no significant differences in overall HRQoL scores between groups. In comparison to the benign cohort, cancer patients showed a significant detriment in the social subdomain score (OR 0.10-0.96, p = 0.017) but not in other subdomains (physical, psychological, spiritual). Female gender, increasing BMI and cancer recurrence were significantly associated with decreased overall HRQoL. Compared to the benign cohort, cancer patients reported more personal and family distress associated with diagnosis and treatment, increased future uncertainty, poorer concentration and greater financial burden. CONCLUSION: Although no difference in overall HRQoL was found between patients undergoing thyroidectomy for benign or malignant disease, detriments in social well-being may persist many years after surgery. Thyroid cancer patients and their families may benefit from increased supports around the time of diagnosis and treatment.

The effect of preoperative skin preparation on clinical outcomes with incisional surgery: a network meta-analysis.

BACKGROUND: Preoperative skin antiseptics are used prior to surgery to reduce the risk of surgical site infection (SSI). There is debate as to which is the most effective. The aim of this network meta-analysis (NMA) is to compare the effectiveness of different skin preparations at reducing SSIs in patients undergoing incisional surgery. METHODS: The study protocol was published in PROSPERO (CRD4202181599) a priori with predefined search terms and inclusion/exclusion criteria. The skin preparations for comparison were: chlorhexidine/alcohol (CHA), chlorhexidine/water (CHW), poviodine/alcohol (PVIA), poviodine/water (PVIW). The records identified were screened by two authors independently by title, abstract and in full text. The revised tool for risk-of bias (ROB2) assessment was used. RESULTS: Twenty-nine RCTs involving 15 796 patients were included in the NMA. A significant but small increase in the odds of infection was seen in the PVIW group compared to the CHA group (OR 1.34, 95%CrI 1.09-1.64), but other comparisons were not statistically significantly different. Ranking the treatment arms showed there was a 64% probability that CHA is the most effective and a 62.7% probability that PVIW is the least effective treatment. CONCLUSION: Chlorhexidine/alcohol (CHA) was found to be the most effective for prevention of superficial and deep SSI while PVIW was the least. There was no differences seen between CHA and PVIA, or CHW and PVIW. The superiority of CHA is likely due to the effect of the alcohol in the base. Hence the choice between CHA and PVIA should be based on health and cost considerations.

Does the introduction of pre-operative cardiopulmonary exercise testing in radical cystectomy delay or alter surgical care?

Objectives: To assess if the introduction of routine pre-operative cardiopulmonary exercise testing (CPET) in radical cystectomy has delayed surgical intervention. Materials and Methods: A prospective database of patients undergoing radical cystectomy in our local health network was maintained. A retrospective analysis of two years (2018-2020) included 38 patients. Of these, 15 patients had CPET pre-operatively, and a direct comparison was performed. Results: The mean time from diagnosis to cystectomy was 95 days in patients who did not have CPET compared to 110 days for those who did (p = 0.32), with comparable rates of neoadjuvant chemotherapy (NAC) (62.5% and 64.29%). Average length of stay was 18.6 days compared with 13.87 (p = 0.16), favouring the CPET group. The CPET group also had a lower readmission rate within 30 days (13.33% compared with 21.05%, p = 0.35). Cause-specific mortality within 90 days was 10.2% and within the study timeframe was 36.84% (estimated 5-year mortality rate 43-65%). Within the CPET group, eight had an anaerobic threshold (AT) of <11 ml/kg/min (range 6.3-10.5): Of these, 50% had Clavien-Dindo complications of grade 2 or higher and the 90-day mortality rate was 37.5% (cf. 0% in those with AT > 11 ml/kg/min in this series). Conclusion: CPET is a valuable risk evaluation tool. This study suggested that CPET contributed to a minor non-significant delay to surgery, however was associated with reduced length of stay and readmission rates, and was a valuable risk evaluation tool. We found that CPET AT <11 ml/kg/min is associated with higher rates of patient morbidity and perioperative mortality.

C1q and mobility score in predicting sarcopenia in an Australian cohort of cancer surgery patients.

BACKGROUND: Sarcopenia has been shown to have significant adverse health outcomes in a range of patient populations. Particularly, sarcopenic patients having cancer surgery are a unique group who demonstrate poorer post-operative outcomes. Currently, the gold standard in diagnosing sarcopenia is through the use of computed tomography. However, the widespread use of imaging to diagnose patients with sarcopenia is neither cost-effective nor practical. Identifying a serum biomarker or a simple mobility scoring system as an alternative diagnostic tool may aid in identifying more patients at risk of sarcopenia. C1q, a novel biomarker, has previously been shown to correlate with sarcopenia. Similarly, we sought to explore whether mobility scores may provide a useful surrogate marker for sarcopenia. METHODS: This was a prospective cohort study of patients who presented for colorectal cancer surgery between the dates of 6/10/2016 and 4/10/2017 at John Hunter Hospital. Computed tomography was utilized to calculate the psoas area at the L3 spinal level. Pre-operative blood samples were obtained for C1q analysis and de Morton Mobility Index (DEMMI) was also performed. RESULTS: A total of 51 patients were included in the study. The median age of the patients were 69 years old. We did not demonstrate a correlation between serum C1q and DEMMI scores with psoas area. CONCLUSION: Our findings suggest that neither C1q nor DEMMI scores are correlated with psoas area in a colorectal cancer population.

Antiseptic Skin Agents to Prevent Surgical Site Infection After Incisional Surgery: A Randomized, Three-armed Combined Non-inferiority and Superiority Clinical Trial (NEWSkin Prep Study).

OBJECTIVE: To compare SSI rates between the skin preparation agents: PI-Aq, povidone-iodine with alcohol (PI-Alc), and chlorhexidine with alcohol (C-Alc). BACKGROUND: Guidelines suggest that alcohol-containing chlorhexidine solutions are the gold standard for skin preparation before surgery. It remains difficult to determine whether it is the chlorhexidine component or the addition of alcohol that confers the most benefit. METHODS: We conducted a multicenter, prospective, combined non-inferiority (PI-Alc vs C-Alc) and superiority (PI-Alc vs PI-Aq) randomized clinical trial. Participants were randomized 1:1:1 to receive either C-Alc, PI-Alc, or PI-Aq. The primary outcome was SSI rate as defined by the Centers for Disease Control. Secondary outcomes were complication rates, length of hospital stay, readmissions, and skin reactions. RESULTS: Between January 2015 and December 2018, 3213 patients were randomized (C-Alc: 1076, PI-Alc: 1075, and PI-Aq: 1062). Mean age of participants was 57% and 55% were female. SSI rates were: C-Alc 11.09%, PI-Alc 10.88%, and PI-Aq 12.56%. PI-Alc was found to be non-inferior to C-Alc (mean difference, -0.21%; 95% confidence interval, -2.85 to 2.44; P = 0.0009 non-inferiority), whereas PI-Alc was not superior to PI-Aq (mean difference, -1.68%; 95% confidence interval, -4.40 to 1.05; P = 0.2302). There were no differences seen in secondary outcomes between groups and no treatment related adverse events or deaths occurred. CONCLUSIONS: PI-Alc is non-inferior to C-Alc and not superior to PI-Aq. This is at odds with current guidelines that suggest alcohol-based chlorhexidine solutions should routinely be used for surgical skin preparation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ANZCTRN12615000021571. www.anzctr.org.au.

Antiseptic Skin Preparation Agents to Prevent Surgical Site Infection in Colorectal Surgery: A 3-Armed Randomized Controlled Trial.

BACKGROUND: There is much debate surrounding the ideal antiseptic skin preparation agent to reduce postoperative surgical site infection. International guidelines suggest that chlorhexidine- and alcohol-containing compounds have superior efficacy. However, there are minimal clinical trials specifically looking at skin preparation agents for colorectal surgery. OBJECTIVE: The aim of this study was to compare the efficacy of chlorhexidine in alcohol versus povidone-iodine in alcohol versus povidone-iodine in aqueous solution for the prevention of surgical site infection in colorectal surgery. DESIGN: This is a prospective, 3-armed, randomized controlled trial. SETTING: This study was conducted at the 800-bed John Hunter Hospital and Newcastle Private Hospital, with all subspecialty services in New South Wales, Australia. PATIENTS: All eligible, consenting adults undergoing colorectal surgery between July 2015 and December 2018 were included. INTERVENTIONS: Patients were andomized to receive preincision skin preparation with one of the following: chlorhexidine in 70% alcohol, povidone-iodine in 70% alcohol, or povidone-iodine in aqueous solution. MAIN OUTCOME MEASURE: The primary measure was surgical site infection within 30 days. RESULTS: A total of 482 patients were randomized to chlorhexidine in alcohol, povidone-iodine in alcohol, or aqueous povidone-iodine. The overall surgical site infection rate was 22% (107/482). There was no difference in rates of surgical site infection: 20.6% (29/141), 22.8% (44/193), and 23.0% (34/148), respectively ( p = 0.5267). There was no difference in complication rates: 54.6% (77/141), 46.1% (89/193), and 49.3% (73/148), respectively ( p = 0.1762). The median length of stay was 6 days in all 3 groups. LIMITATIONS: This is a subset analysis of a larger clinical trial for all forms of incisional surgery (the NewSKIN Prep trial), and noninferiority cannot be assessed. Changes in government regulations resulted in a change from 0.5% chlorhexidine in 70% ethanol to 2% chlorhexidine in 70% ethanol during the trial. CONCLUSION: This large, prospective, randomized clinical trial appears to indicate that there is no difference in surgical site infection, complications, or length of stay among the 3 commonest forms of skin preparation in colorectal surgery. See Video Abstract at http://links.lww.com/DCR/B875 .New Zealand Clinical Trials registry: ACTRN12615000021572Agentes antisépticos para la preparación de la piel para prevenir la infección del sitio quirúrgico en la cirugía colorrectal: un ensayo clínico aleatorizado de tres grupos. ANTECEDENTES: Existe un gran debate en torno al agente de preparación de la piel antiséptico ideal para reducir la infección posoperatoria del sitio quirúrgico. Las pautas internacionales sugieren que los compuestos que contienen clorhexidina y alcohol tienen una eficacia. Sin embargo, existen ensayos clínicos mínimos que analizan específicamente los agentes de preparación de la piel para la cirugía colorrectal. OBJETIVO: Comparar la eficacia de la clorhexidina en alcohol versus povidona yodada en alcohol versus povidona yodada en solución acuosa para la prevención de la infección del sitio quirúrgico en cirugía colorrectal. DISEO: Este es un ensayo controlado aleatorio prospectivo de tres brazos. AJUSTE: Este estudio se realizó en el Hospital John Hunter de 800 camas y el Hospital Privado de Newcastle con todos los servicios de subespecialidad en Nueva Gales del Sur, Australia. PACIENTES: Se incluyeron todos los adultos elegibles que dieron su consentimiento para someterse a una cirugía colorrectal entre julio de 2015 y diciembre de 2018. INTERVENCIONES: Aleatorizados para recibir una preparación para la piel previa a la incisión con uno de: clorhexidina en alcohol al 70%, povidona yodada en alcohol al 70% o povidona yodada en solución acuosa. MEDIDA DE RESULTADO PRINCIPAL: La medida principal fue la infección del sitio quirúrgico dentro de los 30 días. RESULTADOS: Un total de 482 pacientes fueron aleatorizados para recibir clorhexidina en alcohol, povidona yodada en alcohol o povidona yodada acuosa. La tasa global de infección del sitio quirúrgico fue del 22% (107/482). No hubo diferencias en las tasas de infección del sitio quirúrgico; 20,6% (29/141), 22,8% (44/193) y 23,0% (34/148) respectivamente; p = 0,5267. No hubo diferencia en las tasas de complicaciones; 54,6% (77/141), 46,1% (89/193) y 49,3% (73/148) respectivamente; p = 0,1762. La duración media de la estancia hospitalaria fue de 6,0 días en los tres grupos. LIMITACIONES: Este es un análisis de subconjunto de un ensayo clínico más grande para todas las formas de cirugía incisional (el ensayo NewSKIN Prep) y no se puede evaluar la no inferioridad. Los cambios en las regulaciones gubernamentales dieron como resultado un cambio de clorhexidina al 0,5% en etanol al 70% a clorhexidina al 2% en etanol al 70% durante la prueba. CONCLUSINES: Este gran ensayo clínico prospectivo y aleatorizado parece indicar que no hay diferencia en la infección del sitio quirúrgico, las complicaciones o la duración de la estancia entre las 3 formas más comunes de preparación de la piel en la cirugía colorrectal. Consulte Video Resumen en http://links.lww.com/DCR/B875 . (Traducción-Dr. Gonzalo Hagerman )Este ensayo se registró de forma prospectiva en el registro de ensayos clínicos de Australia Nueva Zelanda el 15/01/2015: ACTRN12615000021572.

Patient perceptions of surgical telehealth consultations during the COVID 19 pandemic in Australia: Lessons for future implementation.

INTRODUCTION: Prior studies of telehealth report high levels of patient satisfaction, but within carefully selected clinical scenarios. The COVID-19 pandemic led to telehealth replacing face-to-face care for many surgical consultations across a variety of situations. More evidence is needed regarding patient perceptions of telehealth in surgery, in particular, exploring barriers and facilitators associated with its sustained implementation beyond the pandemic. METHODS: Survey invitations were emailed to a convenience sample of surgical patients by their surgeon following a telehealth consultation during the COVID-19 pandemic. Surgeons were recruited from a sample (n = 683) who completed a survey on telehealth (distributed via email to all Australian Fellows of the Royal Australasian College of Surgeons). Mixed methods analysis was performed of the patient survey data. RESULTS: A total of 1166 consultations were captured: 50% routine reviews, 17% initial appointments and 20% post-operative reviews. Video-link was used in 49% of consultations. The majority of patients (94%), were satisfied with the quality of their surgical telehealth consultation and 75% felt it delivered the same level of care as face-to-face encounters. Telehealth was convenient to use (96%) and led to cost savings for 60% of patients. When asked about future appointment preferences after the pandemic, 41% indicated they would prefer telehealth (24% video-link and 17% telephone) over face-to-face appointments. There was a perception by patients that telehealth consultation fees should be less than face-to-face consultation fees. CONCLUSION: Patient satisfaction with surgical telehealth consultations is high. Barriers to more widespread implementation include financial, clinical appropriateness, technical and confidentiality concerns.

Modeling geogenic and atmospheric nitrogen through the East River Watershed, Colorado Rocky Mountains.

There is a growing understanding of the role that bedrock weathering can play as a source of nitrogen (N) to soils, groundwater and river systems. The significance is particularly apparent in mountainous environments where weathering fluxes can be large. However, our understanding of the relative contributions of rock-derived, or geogenic, N to the total N supply of mountainous watersheds remains poorly understood. In this study, we develop the High-Altitude Nitrogen Suite of Models (HAN-SoMo), a watershed-scale ensemble of process-based models to quantify the relative sources, transformations, and sinks of geogenic and atmospheric N through a mountain watershed. Our study is based in the East River Watershed (ERW) in the Upper Colorado River Basin. The East River is a near-pristine headwater watershed underlain primarily by an N-rich Mancos Shale bedrock, enabling the timing and magnitude of geogenic and atmospheric contributions to watershed scale dissolved N-exports to be quantified. Several calibration scenarios were developed to explore equifinality using >1600 N concentration measurements from streams, groundwater, and vadose zone samples collected over the course of four years across the watershed. When accounting for recycling of N through plant litter turnover, rock weathering accounts for approximately 12% of the annual dissolved N sources to the watershed in the most probable calibration scenario (0-31% in other scenarios), and 21% (0-44% in other scenarios) when considering only "new" N sources (i.e. geogenic and atmospheric). On an annual scale, instream dissolved N elimination, plant turnover (including cattle grazing) and atmospheric deposition are the most important controls on N cycling.

Utilization of telehealth by surgeons during the COVID 19 pandemic in Australia: lessons learnt.

BACKGROUND: The COVID-19 pandemic has led to the rapid and widespread adoption of telehealth. There is a need for more evidence regarding the appropriateness of telehealth, as well as greater understanding of barriers to its sustained use within surgery in Australia. METHODS: A survey weblink was sent via email to 5558 Australian Fellows of the Royal Australasian College of Surgeons in August 2020. A single reminder email followed this 2 weeks later. Mixed methods analysis was performed of the survey data. RESULTS: There were 683 (12.3%) complete responses. Telehealth (telephone or video-link) consultations were undertaken by 638 (85%) respondents as a result of the pandemic, with 583 (85%) of these expressing a desire for continued access to telehealth. Seventy-seven percent of respondents felt that a satisfactory level of care could be delivered via telehealth in half or more consultations. However, only 38% of respondents felt that quality of care was equivalent comparing telehealth and face-to-face consultations, with the inability to perform a clinical examination a frequent concern. The majority agreed that telehealth was appropriate for clinical meetings and arranging investigations (91% each), whereas only 22% and 17%, respectively, felt telehealth was an appropriate means to break bad news and manage conflict. Medicolegal, technical and financial concerns were raised as prominent barriers to the sustained use of telehealth. CONCLUSION: Surgeons show good insight into the clinical appropriateness and limitations of telehealth. Medicolegal, technical and financial barriers need to be addressed in order to fully utilize the benefits of telehealth into the future.

Post-discharge opioid prescribing after laparoscopic appendicectomy and cholecystectomy.

BACKGROUND: Opioid over-prescription following surgery is a significant public health issue in most developed countries. Multiple studies have been conducted in the USA demonstrating and investigating the issue; however, there is a lack of literature addressing this topic in the Australian setting. The aim of this study is to review prescribing practices at an Australian tertiary referral hospital on discharge in patients having undergone laparoscopic cholecystectomy (LC) or laparoscopic appendicetomy (LA). Additionally, to identify potential factors which influence medical officer prescribing practices. METHODS: A retrospective observational study on opioid prescribing practice on all patients who underwent LC or LA over a 12-month period at an Australian tertiary referral hospital. RESULTS: A total of 435 patients (223 LC, 214 LA) were prescribed a mean opioid dose on discharge of 25 oral morphine milli-equivalents (range 0-180 morphine milli-equivalents). Less opioids were prescribed following elective procedures (42% versus 10%, P < 0.001). There is a downward trend of opioid prescribing on discharge as the Junior Medical Officer clinical year progresses (P < 0.001). CONCLUSIONS: This study demonstrates a lower rate of opiate prescription on discharge for LC and LA in an Australian setting when compared to the US data. There is a wide diversity of prescribing demonstrated. This indicates the need for better training of opioid prescribers to reduce over-prescribing.

Correction to: Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

[This corrects the article DOI: 10.1186/s13017-019-0259-9.].

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

Background: Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body: Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions: A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.

High-dose preoperative cholecalciferol to prevent post-thyroidectomy hypocalcaemia: A randomized, double-blinded placebo-controlled trial.

OBJECTIVE: Post-thyroidectomy hypocalcaemia is a significant cause of morbidity and prolonged hospitalization, usually due to transient parathyroid gland damage, treated with calcium and vitamin D supplementation. We present a randomized, double-blinded placebo-controlled trial of preoperative loading with high-dose cholecalciferol (300 000 IU) to reduce post-thyroidectomy hypocalcaemia. PATIENTS AND MEASUREMENTS: Patients (n = 160) presenting for thyroidectomy at tertiary hospitals were randomized 1:1 to cholecalciferol (300 000 IU) or placebo 7 days prior to thyroidectomy. Ten patients withdrew prior to surgery. The primary outcome was post-operative hypocalcaemia (corrected calcium <2.1 mmol/L in first 180 days). RESULTS: The study included 150 patients undergoing thyroidectomy for Graves' disease (31%), malignancy (20%) and goitre (49%). Mean pre-enrolment vitamin D was 72 ± 26 nmol/L. Postoperative hypocalcaemia occurred in 21/72 (29%) assigned to cholecalciferol and 30/78 (38%) participants assigned to placebo (P = 0.23). There were no differences in secondary end-points between groups. In pre-specified stratification, baseline vitamin D status did not predict hypocalcaemia, although most individuals were vitamin D replete at baseline. Post-hoc stratification by day 1 parathyroid hormone (PTH) (<10 pg/mL, low vs ≥10 pg/mL, normal) was explored due to highly divergent rates of hypocalcaemia in these groups. Using a Cox regression model, the hazard ratio for hypocalcaemia in the cholecalciferol group was 0.56 (95%CI 0.32-0.98, P = 0.04) after stratification for Day 1 PTH. Further clinical benefits were observed in these subgroups. CONCLUSIONS: Pre-thyroidectomy treatment with high-dose cholecalciferol did not reduce the overall rate of hypocalcaemia following thyroidectomy. In subgroups stratified by day 1 PTH status, improved clinical outcomes were noted.