Changes in Sex Related Mortality after Revascularisation for Chronic Limb Threatening Ischaemia: A National Observational Study 1994 - 2018.

OBJECTIVE: The aim of this study was to compare all cause mortality across three time periods with a focus on sex differences after revascularisation for chronic limb threatening ischaemia between 1994 and 2013 in Sweden. METHODS: In this observational registry study, patients registered in the Swedish vascular registry (Swedvasc), revascularised between 1994 and 2013 with open or endovascular infra-inguinal procedures, were divided into three time periods: 1994 - 1999, 2000 - 2006, and 2007 - 2013. Patients were followed for five years. Poisson regression was used to compare 30 day mortality, presented as adjusted relative risk ratio (aRR). Adjusted restricted mean survival time (aRMST) differences at five years were compared with a generalised linear model. The analyses were adjusted for age, comorbidities, and endovascular or open surgery. Comparison with the general Swedish population was also conducted with age adjusted standardised mortality ratios. Results are presented with the 95% confidence interval (CI). RESULTS: The study showed increasing 30 day mortality, with an aRR of 1.47 (95% CI 1.31 - 1.65) for women and aRR of 1.20 (95% CI 1.06 - 1.35) for men, per time period. In women, the five year RMST decreased from the first to the third period, with an aRMST of -45 (95% CI -59 - -32) days per period. In men, the aRMST increased 32 (95% CI 18 - 47) days per period. When comparing sexes, women showed lower 30 day mortality and higher five year survival than men in the first time period, but a significantly worse development over time periods than for men. Corresponding findings were observed in comparison with the general Swedish population. CONCLUSION: This study showed an increased 30 day mortality in women and men across the periods, most evident in women. Men showed an increased five year survival across the periods, whereas opposite findings were recorded for women. The dismal trend over time for women could not be explained by increased age or a higher prevalence of comorbidities.

Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden: A stepped wedge cluster randomised trial.

BACKGROUND: The World Health Organisation (WHO) 2013 diagnostic criteria for gestational diabetes mellitus (GDM) has been criticised due to the limited evidence of benefits on pregnancy outcomes in different populations when switching from previously higher glycemic thresholds to the lower WHO-2013 diagnostic criteria. The aim of this study was to determine whether the switch from previous Swedish (SWE-GDM) to the WHO-2013 GDM criteria in Sweden following risk factor-based screening improves pregnancy outcomes. METHODS AND FINDINGS: A stepped wedge cluster randomised trial was performed between January 1 and December 31, 2018 in 11 clusters (17 delivery units) across Sweden, including all pregnancies under care and excluding preexisting diabetes, gastric bypass surgery, or multifetal pregnancies from the analysis. After implementation of uniform clinical and laboratory guidelines, a number of clusters were randomised to intervention (switch to WHO-2013 GDM criteria) each month from February to November 2018. The primary outcome was large for gestational age (LGA, defined as birth weight >90th percentile). Other secondary and prespecified outcomes included maternal and neonatal birth complications. Primary analysis was by modified intention to treat (mITT), excluding 3 clusters that were randomised before study start but were unable to implement the intervention. Prespecified subgroup analysis was undertaken among those discordant for the definition of GDM. Multilevel mixed regression models were used to compare outcome LGA between WHO-2013 and SWE-GDM groups adjusted for clusters, time periods, and potential confounders. Multiple imputation was used for missing potential confounding variables. In the mITT analysis, 47 080 pregnancies were included with 6 882 (14.6%) oral glucose tolerance tests (OGTTs) performed. The GDM prevalence increased from 595/22 797 (2.6%) to 1 591/24 283 (6.6%) after the intervention. In the mITT population, the switch was associated with no change in primary outcome LGA (2 790/24 209 (11.5%) versus 2 584/22 707 (11.4%)) producing an adjusted risk ratio (aRR) of 0.97 (95% confidence interval 0.91 to 1.02, p = 0.26). In the subgroup, the prevalence of LGA was 273/956 (28.8%) before and 278/1 239 (22.5%) after the switch, aRR 0.87 (95% CI 0.75 to 1.01, p = 0.076). No serious events were reported. Potential limitations of this trial are mainly due to the trial design, including failure to adhere to guidelines within and between the clusters and influences of unidentified temporal variations. CONCLUSIONS: In this study, implementing the WHO-2013 criteria in Sweden with risk factor-based screening did not significantly reduce LGA prevalence defined as birth weight >90th percentile, in the total population, or in the subgroup discordant for the definition of GDM. Future studies are needed to evaluate the effects of treating different glucose thresholds during pregnancy in different populations, with different screening strategies and clinical management guidelines, to optimise women's and children's health in the short and long term. TRIAL REGISTRATION: The trial is registered with ISRCTN (41918550).

Immediate mobilization in post-anesthesia care unit does not increase overall postoperative physical activity after elective colorectal surgery: A randomized, double-blinded controlled trial within an enhanced recovery protocol.

BACKGROUND: The level of post-operative mobilization according to Enhanced Recovery After Surgery (ERAS) guidelines is not always achieved. We investigated whether immediate mobilization increases postoperative physical activity. The objective was to evaluate the effects of immediate postoperative mobilization in the post-anesthesia care unit (PACU) compared to standard care. METHODS: This randomized controlled trial, involved 144 patients, age ≥18 years, undergoing elective colorectal surgery. Patients were randomized to mobilization starting 30 min after arrival in the PACU, or to standard care. Standard care consisted of mobilization a few hours later at the ward according to ERAS guidelines. The primary outcome was physical activity, in terms of number of steps, measured with an accelerometer during postoperative days (PODs) 1-3. Secondary outcomes were physical capacity, functional mobility, time to readiness for discharge, complications, compliance with the ERAS protocol, and physical activity 1 month after surgery. RESULTS: With the intention-to-treat analysis of 144 participants (median age 71, 58% female) 47% underwent laparoscopic-or robotic-assisted surgery. No differences in physical activity during hospital stay were found between the participants in the intervention group compared to the standard care group (adjusted mean ratio 0.97 on POD 1 [95% CI, 0.75-1.27], p = 0.84; 0.89 on POD 2 [95% CI, 0.68-1.16], p = 0.39, and 0.90 on POD 3 [95% CI, 0.69-1.17], p = 0.44); no differences were found in any of the other outcome measures. CONCLUSIONS: Addition of the intervention of immediate mobilization to standard care did not make the patients more physically active during their hospital stay. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NTC 03357497.

Five-Year Follow-Up After Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis and Concomitant Coronary Artery Disease: A Single-Center Experience

ABSTRACT Introduction: There is no consensus on the impact of coronary artery disease in patients undergoing transcatheter aortic valve implantation. Therefore, the objective of this study was, in a single-center setting, to evaluate the five-year outcome of transcatheter aortic valve implantation patients with or without coronary artery disease. Methods: All transcatheter aortic valve implantation patients between 2009 and 2019 were included and grouped according to the presence or absence of coronary artery disease. The primary endpoint, five-year all-cause mortality, was evaluated using Cox regression adjusted for age, sex, procedure years, and comorbidities. Comorbidities interacting with coronary artery disease were evaluated with interaction tests. In-hospital complications was the secondary endpoint. Results: In total, 176 patients had aortic stenosis and concomitant coronary artery disease, while 170 patients had aortic stenosis only. Mean follow-up was 2.2±1.6 years. There was no difference in the adjusted five-year all-cause mortality between transcatheter aortic valve implantation patients with and without coronary artery disease (hazard ratio 1.00, 95% confidence interval 0.59-1.70, P=0.99). In coronary artery disease patients, impaired renal function, peripheral arterial disease, or ejection fraction < 50% showed a significant interaction effect with higher five-year all-cause mortality. No significant differences in complications between the groups were found. Conclusion: Five-year mortality did not differ between transcatheter aortic valve implantation patients with or without coronary artery disease. However, in patients with coronary artery disease and impaired renal function, peripheral arterial disease, or ejection fraction < 50%, we found significantly higher five-year all-cause mortality.

Reliability of the DSS-Swe Questionnaire.

BACKGROUND: Symptomatic postbariatric hypoglycemia (PBH) is a known complication that can occur a few years after Roux-en-Y gastric bypass (RYGB). There is currently no established rating scale for PBH-associated symptoms developed for use in Swedish populations. The aim of the study was to translate an already existing questionnaire into Swedish and to test its reliability. METHODS: The study included forward and backward translations of the original Dumping Severity Scale (DSS) questionnaire with 8 items regarding symptoms of early dumping and 6 items regarding hypoglycemia, with each item graded on a 4-point Likert scale. The reliability of the Swedish translated questionnaire (DSS-Swe) was estimated using internal consistency and test-retest methods. RESULTS: A total of 200 patients were included in the study. Good internal consistency was demonstrated regarding the items related to early dumping symptoms, with a Cronbach's alpha coefficient of 0.82, and very good agreement in terms of test-retest reliability, with an overall intraclass correlation coefficient (ICC) of 0.91 (95% CI 0.88-0.93). The items related to hypoglycemia yielded a good Cronbach's alpha coefficient of 0.76 and an ICC of 0.89 (95% CI 0.85-0.91). CONCLUSION: The DSS-Swe questionnaire shows good reliability regarding both internal consistency and test-retest performance for use in Swedish populations.

Five-Year Follow-Up After Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis and Concomitant Coronary Artery Disease: A Single-Center Experience.

INTRODUCTION: There is no consensus on the impact of coronary artery disease in patients undergoing transcatheter aortic valve implantation. Therefore, the objective of this study was, in a single-center setting, to evaluate the five-year outcome of transcatheter aortic valve implantation patients with or without coronary artery disease. METHODS: All transcatheter aortic valve implantation patients between 2009 and 2019 were included and grouped according to the presence or absence of coronary artery disease. The primary endpoint, five-year all-cause mortality, was evaluated using Cox regression adjusted for age, sex, procedure years, and comorbidities. Comorbidities interacting with coronary artery disease were evaluated with interaction tests. In-hospital complications was the secondary endpoint. RESULTS: In total, 176 patients had aortic stenosis and concomitant coronary artery disease, while 170 patients had aortic stenosis only. Mean follow-up was 2.2±1.6 years. There was no difference in the adjusted five-year all-cause mortality between transcatheter aortic valve implantation patients with and without coronary artery disease (hazard ratio 1.00, 95% confidence interval 0.59-1.70, P=0.99). In coronary artery disease patients, impaired renal function, peripheral arterial disease, or ejection fraction < 50% showed a significant interaction effect with higher five-year all-cause mortality. No significant differences in complications between the groups were found. CONCLUSION: Five-year mortality did not differ between transcatheter aortic valve implantation patients with or without coronary artery disease. However, in patients with coronary artery disease and impaired renal function, peripheral arterial disease, or ejection fraction < 50%, we found significantly higher five-year all-cause mortality.

Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery: A Randomized Clinical Trial.

Importance: Short-term and midterm data suggest that mesenteric defects closure during laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery reduces the risk of internal herniation with small bowel obstruction (SBO) but may increase risk of kinking of the jejunojejunostomy in the early postoperative period. However, to our knowledge, there are no clinical trials reporting long-term results from this intervention in terms of risk for SBO or opioid use. Objective: To evaluate long-term safety and efficacy outcomes of closure of mesenteric defects during LRYGB. Design, Setting, and Participants: This randomized clinical trial with a 2-arm, parallel, open-label design included patients with severe obesity scheduled for LRYGB bariatric surgery at 12 centers in Sweden from May 1, 2010, through November 14, 2011, with 10 years of follow-up after the intervention. Interventions: During the operation, patients were randomly assigned 1:1 to closure of mesenteric defects beneath the jejunojejunostomy and at the Petersen space using nonabsorbable running sutures during LRYGB or to nonclosure. Main Outcome and Measures: The primary outcome was reoperation for SBO. New incident, chronic opioid use was a secondary end point as a measure of harm. Results: A total of 2507 patients (mean [SD] age, 41.7 [10.7] years; 1863 female [74.3%]) were randomly assigned to closure of mesenteric defects (n = 1259) or nonclosure (n = 1248). After censoring for death and emigration, 1193 patients in the closure group (94.8%) and 1198 in the nonclosure group (96.0%) were followed up until the study closed. Over a median follow-up of 10 years (IQR, 10.0-10.0 years), a reoperation for SBO from day 31 to 10 years after surgery was performed in 185 patients with nonclosure (10-year cumulative incidence, 14.9%; 95% CI, 13.0%-16.9%) and in 98 patients with closure (10-year cumulative incidence, 7.8%; 95% CI, 6.4%-9.4%) (subhazard ratio [SHR], 0.42; 95% CI, 0.32-0.55). New incident chronic opioid use was seen among 175 of 863 opioid-naive patients with nonclosure (10-year cumulative incidence, 20.4%; 95% CI, 17.7%-23.0%) and 166 of 895 opioid-naive patients with closure (10-year cumulative incidence, 18.7%; 95% CI, 16.2%-21.3%) (SHR, 0.90; 95% CI, 0.73-1.11). Conclusions and Relevance: This randomized clinical trial found long-term reduced risk of SBO after mesenteric defects closure in LRYGB. The findings suggest that routine use of this procedure during LRYGB should be considered. Trial Registration: ClinicalTrials.gov Identifier: NCT01137201.

Balloon dilatation is superior to CO2 laser excision in the treatment of subglottic stenosis.

INTRODUCTION: Endoscopic treatment of subglottic stenosis (SGS) is regarded as a safe procedure with rare complications and less morbidity than open surgery yet related with a high risk of recurrence. The abundance of techniques and adjuvant therapies complicates a comparison of the different surgical approaches. The primary aim of this study was to investigate disease recurrence after CO2 laser excisions and balloon dilatation in patients with SGS and to identify potential confounding factors. MATERIALS AND METHODS: In a tertiary referral center, two cohorts of previously undiagnosed patients treated for SGS were retrospectively reviewed and followed for 3 years. The CO2 laser cohort (CLC) was recruited between 2006 and 2011, and the balloon dilatation cohort (BDC) between 2014 and 2019. Kaplan‒Meier and multivariable Cox regression analyzed time to repeated surgery and estimated hazard ratios (HRs) for different variables. RESULTS: Nineteen patients were included in the CLC, and 31 in the BDC. The 1-year cumulative recurrence risk was 63.2% for the CLC compared with 12.9% for the BDC (HR 33.0, 95% CI 6.57-166, p < 0.001), and the 3-year recurrence risk was 73.7% for the CLC compared with 51.6% for the BDC (HR 8.02, 95% CI 2.39-26.9, p < 0.001). Recurrence was independently associated with overweight (HR 3.45, 95% CI 1.16-10.19, p = 0.025), obesity (HR 7.11, 95% CI 2.19-23.04, p = 0.001), and younger age at diagnosis (HR 8.18, 95% CI 1.43-46.82, p = 0.018). CONCLUSION: CO2 laser treatment is associated with an elevated risk for recurrence of SGS compared with balloon dilatation. Other risk factors include overweight, obesity, and a younger age at diagnosis.

Previous pre-eclampsia, gestational diabetes mellitus and the risk of cardiovascular disease: A nested case-control study in Sweden.

OBJECTIVE: Pre-eclampsia and gestational diabetes mellitus (GDM) are two common pregnancy complications that affect birth outcomes and are associated with a long-term risk of cardiovascular disease (CVD). The aims of this study were to investigate if the pre-eclampsia association with CVD is independent of GDM and modified by body mass index (BMI) or GDM. DESIGN: Case-control study. SETTING: Sweden. POPULATION: Cases were women with a first CVD event between 1991 and 2008 and a previous pregnancy who were matched with controls without CVD (1:5) by year of birth, age and region of birth. METHODS: Conditional logistic regression was used to evaluate the associations of GDM, pre-eclampsia and maternal BMI with CVD adjusted for potential confounders and effect modifications with interaction tests. MAIN OUTCOME MEASURES: CVD. RESULTS: There were 2639 cases and 13 310 controls with complete data. Pre-eclampsia and GDM were independent risk factors for CVD (adjusted odds ratio [aOR] 2.59, 95% CI 2.12-3.17 and aOR 1.47, 95% CI 1.04-2.09, respectively). After stratifying by maternal BMI, the adjusted association of pre-eclampsia with CVD did not differ notably between BMI groups: normal weight (aOR 2.65, 95% CI 1.90-3.69), overweight (aOR 2.67, 95% CI 1.52-4.68) and obesity (aOR 3.03, 95% CI 0.74-12.4). Similar findings were seen when stratifying on GDM/non-GDM. CONCLUSIONS: Pre-eclampsia and GDM are independent risk factors for later CVD and having both during pregnancy is a major risk factor for later CVD. The association between pre-eclampsia and CVD is not modified by BMI. Effective CVD preventive programs for high-risk women are urgently needed in order to improve women's long-term health.

Ultrasound-assisted resection of oral tongue cancer.

BACKGROUND: In surgical resection of squamous cell carcinoma of the oral tongue (SCCOT), achieving clear margins is important for prognosis. Insufficient histopathological margins are common, particularly deep margins. AIMS/OBJECTIVES: The aim of the present study was to determine whether ultrasound (US)-assisted resection could decrease the proportion of insufficient histopathological deep margins in SCCOT. MATERIAL AND METHODS: 34 patients with SCCOT undergoing US-assisted resection (study group) were compared to 76 whose resections were performed without US (conventional group). Outcome measures were insufficient deep histopathological resection margins and mean difference in deep margins. RESULTS: Insufficient deep resection margins (<5.0 mm) were seen in 8 of 34 (23.5%) in the study group, compared to 31 of 76 (40.8%) in the conventional group, unadjusted RR 0.58 [95% CI 0.30-1.12; p = .11], adjusted RR 0.82 [95% CI 0.35-1.92; p = .64]. Unadjusted mean difference was 1.4 mm (95% CI 0.1-2.7, p = .04), adjusted mean difference 1.1 mm (95% CI -2.7 to 0.5, p = .19). CONCLUSIONS: Intraoperative US can visualize the deep resection margins in T1/T2 SCCOT. US-assisted resection seems to decrease the number of insufficient histopathological deep margins, though the results are not statistically significant. Comparatively good results in the conventional group is one explanation for the lack of significance. CLINICALTRIALS.GOV ID: NCT04059861.

Ultrasound accurately assesses depth of invasion in T1-T2 oral tongue cancer.

Background: Depth of invasion (DOI) is important for the T-classification of squamous cell carcinoma of the oral tongue (SCCOT) and incorporated in the TNM 8 classification of oral cavity cancer. To determine DOI clinical palpation is performed, but the preferred radiological modality remains controversial. The aim of this study was to investigate the assessment of DOI using ultrasound (US-DOI). Methods: The DOI was assessed in 40 patients with T1-T3 SCCOT by ultrasound, palpation, computed tomography and magnetic resonance imaging (MRI). Histopathological DOI (H-DOI) was gold standard. Bland-Altman analysis was used to compare mean difference and 95% limits of agreement (LOA). Results: The mean difference of US-DOI was -0.5 mm (95% LOA -4.9-4.0) compared to H-DOI and the mean difference for MRI was 3.9 mm (95% LOA -2.3-10.2). In the subgroup analysis of cT1-T2 the US-DOI mean difference was 0.1 mm and the 95% LOA limits -2.5-2.7. Conclusions: Ultrasound seems to be the most accurate method to assess DOI in T1-T2 SCCOT. MRI overestimates DOI and cannot assess a substantial proportion of the tumors. Level of Evidence: 2c.

Surgical-site infection after hip fracture surgery: preoperative full-body disinfection compared to local disinfection of the surgical site-a population-based observational cohort study.

PURPOSE: Swedish national guidelines recommend full-body disinfection (FBD) with 4% chlorhexidine before hip fracture surgery to prevent surgical-site infection (SSI) despite little evidence. Our objective was to compare preoperative FBD with local disinfection (LD) of the surgical site regarding SSI incidence. METHODS: All patients with hip fracture, operated at a hospital in Sweden, January 1, 2018 to December 31, 2019 were included. Patients in 2018 (n = 237) were prepared with FBD and patients in 2019 (n = 259) with LD. Primary outcome was SSI and secondary outcome was SSI and/or death. We adjusted for potential confounders with logistic regression. The adjusted analysis was performed in two models to enable assessment of variables that lacked either outcome; in the first model, these variables were not adjusted, and the second model was restricted to a sub-population not affected by respective variables. RESULTS: There were 16 (6.8%) cases of SSI in 2018 and 8 (3.1%) cases in 2019. FBD (2018) compared to LD (2019) presented an adjusted OR of 1.9 (95%CI 0.8-4.9, P = 0.16) respectively 2.0 (95%CI 0.8-5.1, P = 0.14) in the two models of the logistic regression. In addition, 40 (16.9%) patients in 2018 and 29 (11.2%) patients in 2019 had the combined outcome of SSI and/or death, adjusted OR 1.6 (95% CI 0.9-2.8, P = 0.08) respectively 1.7 (95% CI 0.9-2.9, P = 0.06). CONCLUSION: We found a non-significant increased risk of SSI 2018 compared to 2019 after adjustment. Randomized control trials are needed. Nonetheless, results suggest that LD is not inferior to FBD regarding SSI prevention, meaning patients could potentially be spared substantial pain.

Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits following acute myocardial infarction (AMI), but large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI. METHODS: The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months. DISCUSSION: Controlling hyperlipidemia and inflammation is critical to preventing new cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention after AMI. TRIAL REGISTRATION: ClinicalTrials.gov NCT03620266 . Registered on August 8, 2018.

Comparison between epidural and intravenous analgesia effects on disease-free survival after colorectal cancer surgery: a randomised multicentre controlled trial.

BACKGROUND: Thoracic epidural analgesia (TEA) has been suggested to improve survival after curative surgery for colorectal cancer compared with systemic opioid analgesia. The evidence, exclusively based on retrospective studies, is contradictory. METHODS: In this prospective, multicentre study, patients scheduled for elective colorectal cancer surgery between June 2011 and May 2017 were randomised to TEA or patient-controlled i.v. analgesia (PCA) with morphine. The primary endpoint was disease-free survival at 5 yr after surgery. Secondary outcomes were postoperative pain, complications, length of stay (LOS) at the hospital, and first return to intended oncologic therapy (RIOT). RESULTS: We enrolled 221 (110 TEA and 111 PCA) patients in the study, and 180 (89 TEA and 91 PCA) were included in the primary outcome. Disease-free survival at 5 yr was 76% in the TEA group and 69% in the PCA group; unadjusted hazard ratio (HR): 1.31 (95% confidence interval [CI]: 0.74-2.32), P=0.35; adjusted HR: 1.19 (95% CI: 0.61-2.31), P=0.61. Patients in the TEA group had significantly better pain relief during the first 24 h, but not thereafter, in open and minimally invasive procedures. There were no differences in postoperative complications, LOS, or RIOT between the groups. CONCLUSIONS: There was no significant difference between the TEA and PCA groups in disease-free survival at 5 yr in patients undergoing surgery for colorectal cancer. Other than a reduction in postoperative pain during the first 24 h after surgery, no other differences were found between TEA compared with i.v. PCA with morphine.

Differential clustering of fecal and mucosa-associated microbiota in 'healthy' individuals.

OBJECTIVE: Fecal samples are often used to characterize gut microbiota. However, whether or not fecal microbiota differs from mucosa-associated microbiota remains largely unknown. This may be specifically relevant in conditions that are characterized by complex mucosal microbe-host interactions, such as Crohn's disease. We aimed to determine the degree of agreement between fecal and mucosal microbiota profiles in 'healthy' individuals, using two commonly used collection procedures. METHODS: The gut microbiota composition of fecal samples (sent at ambient temperature before storage at -70°C) and of colonic biopsies (obtained at endoscopy and immediately stored at -70°C) was determined by sequencing the 16S rRNA gene. Altogether 31 randomly selected 'healthy' individuals from the population-based colonoscopy (Popcol) study were included. RESULTS: The fecal samples were characterized by a reduced degree of richness (P < 0.0001) and diversity (P = 0.016), and also differences in several phyla, including a lower relative abundance of Proteobacteria (P < 0.0001) and Verrucomicrobia (P = 0.008) than in biopsies. Only three of 30 individuals had a similar fecal and mucosal microbiota profile, based on weighted UniFrac analysis. A difference in Crohn's disease dysbiosis-associated bacteria was observed, including a lower relative abundance of Faecalibacterium (P = 0.004) and a higher relative abundance of Ruminococcus (P = 0.001) in feces than in biopsies. CONCLUSIONS: The observed differences between fecal samples, transported at ambient temperature, and the colonic mucosa-associated microbiota have implications for the interpretation of the previous literature, and may be specifically relevant to studies on Crohn's disease.

Influence of the subtype on local recurrence risk of breast cancer with or without radiation therapy.

PURPOSE: To investigate if intrinsic subtypes of breast cancer predict different risks of ipsilateral breast tumor recurrence (IBTR) following breast-conserving surgery (BCS) with and without postoperative radiation therapy. PATIENTS AND METHODS: We randomized 381 women with a unifocal T1N0M0 breast cancer to BCS alone (197 women) or BCS plus postoperative radiation therapy (XRT) (184 women). All available histopathological material was re-analyzed with modern immunohistochemical methods (223 women). After 20 years of complete follow-up we analyzed the risk of IBTR by intrinsic breast cancer subtypes (luminal A, luminal B/HER2-negative, luminal B/HER2-positive, HER2-positive and triple negative). We used Cox regression analyses to estimate hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: In a multivariate analysis the luminal B/HER2-negative subtype, compared with the luminal A subtype, was associated with a higher risk of IBTR overall (HR 3.04; 95% CI 1.38-6.71) and in both the XRT-group (HR 5.08 95% CI 1.31-19.7) and the non-XRT-group (HR 2.58 95%CI 1.07-6.20); (p for interaction = 0.37). The risk of IBTR in the XRT- and non-XRT group, stratified by intrinsic subtype, revealed an absolute risk difference at 20 years to the benefit of XRT of 14% (95% CI 1.0%-26%) for luminal A, 17% (95% CI -6.0% to 39%) for luminal B/HER2 negative and 22% (95% CI -7.0-51%) for the high-risk group. CONCLUSIONS: Among breast cancer patients treated with BCS, the luminal B/HER2-negative subtype predicts an about 3-fold higher risk for IBTR compared to other intrinsic subtypes independent of postoperative radiation therapy.

Local infiltration analgesia: a 2-year follow-up of patients undergoing total hip arthroplasty.

PURPOSE: Local infiltration analgesia (LIA) is commonly used for postoperative pain management following total hip arthroplasty (THA). However, the long-term effects of the component drugs are unclear. The aim of our study was to investigate functional outcome, quality of life, chronic post-surgical pain, and adverse events in patients within 2 years of undergoing THA. METHODS: The study was a secondary analysis of data from a previous larger study. Eighty patients were randomized to receive either intrathecal morphine (Group ITM) or local infiltration analgesia (Group LIA) for pain management in a double-blind study. The parameters measured were patient-assessed functional outcome [using the Hip dysfunction and Osteo-arthritis Outcome Score (HOOS) questionnaire], health-related quality of life [using the European Quality of Life-5 dimensions (EQ-5D) questionnaire and the 36-Item Short Form Health Survey (SF-36) score], and pain using the numeric rating score (NRS), with persistent post-surgical pain having a NRS of > 3 or a HOOS pain sub-score of > 30. All complications and adverse events were investigated during the first 2 years after primary surgery. RESULTS: Pain intensity and rescue analgesic consumption were similar between the groups after hospital discharge. No differences were found in HOOS or SF-36 score between the groups up to 6 months after surgery. A significant group × time interaction was seen in the EQ 5D form in favor of the LIA group. No between-group difference in persistent post-surgical pain was found at 3 or 6 months, or in adverse events up to 2 years after surgery. CONCLUSION: Analysis of functional outcome, quality of life, and post-discharge surgical pain did not reveal significant differences between patients receiving LIA and those receiving ITM. LIA was found to be a safe technique for THA during the long-term follow-up. However, it should be noted that these conclusions are based on a limited number of patients.

Local infiltration analgesia or femoral nerve block for postoperative pain management in patients undergoing total hip arthroplasty. A randomized, double-blind study.

BACKGROUND AND AIMS: Several methods for pain management following total hip arthroplasty (THA) have been described but the best postoperative pain management technique remains uncertain. We compared surgeon applied local infiltration analgesia (LIA) with anaesthesiologist performed femoral nerve block (FNB) using ultrasound. The primary aim was to assess pain intensity 24h after THA. METHODS: In this randomized, double-blind study, 56 patients (ASA I-III) undergoing THA consented to participate. In Group FNB, patients received an ultrasound-guided femoral nerve block using 30ml of ropivacaine 7.5mg/ml (225mg) while Group LIA received a similar volume of saline. Spinal anaesthesia was then performed and bupivacaine heavy, 3-3.5ml injected depending on patient characteristics. During surgery, patients in Group LIA received a mixture of 300mg (150ml) ropivacaine, ketorolac 30mg (1ml) and adrenaline 0.5mg (0.5ml) (total volume 151.5ml) peri-articularly and subcutaneously while Group FNB received 151.5ml of saline peri-articularly in a systematic way by the surgeon. A multi-hole catheter was placed with the tip placed intra-articularly at the end of surgery in both groups. After 23h, the LIA mixture consisting of 20ml ropivacaine (7.5mg/ml), ketorolac 30mg (1ml), adrenaline 0.1mg (1ml) (total volume 22ml) was injected in Group LIA and the same volume of saline in Group FNB. Postoperative pain, analgesic consumption (postoperative and post-discharge), side effects, home discharge, quality of life and hip function were recorded, the latter up to 6 months after surgery. RESULTS: Postoperative pain intensity was significantly lower in Group LIA compared to Group FNB during mobilization at 24h (primary endpoint), mean difference 1.8 NRS units (95% CI 0.7-2.9) (P=0.006), at rest after 4h (P=0.029) and on standing after 24 (P=0.0003) and 48h (P=0.043). Rescue morphine consumption was also significantly lower in Group LIA during 0-24, mean difference 13.5mg (95% CI, 6.1-20.9) (P=0.002) postoperatively. Motor block was greater at 6h (P=0.029) postoperatively in Group FNB. Two patients (one in each group) had persistent post-surgical pain (NRS>3) at 3 months (3.6%) but none at 6 month. No other differences were found between the groups. CONCLUSION: Local infiltration analgesia significantly reduces pain intensity on standing and mobilization, and rescue analgesic consumption compared to femoral nerve block without causing significant side effects. The superior analgesia in the LIA group may result from the secondary injection at 23h postoperatively and needs to be further evaluated in future studies. No differences were found in home discharge, quality of life and hip dysfunction between the groups. IMPLICATION: Local infiltration analgesia is the preferred method for postoperative pain management following THA compared to single-shot femoral nerve block.

Time-to-intubation in obese patients. A randomized study comparing direct laryngoscopy and videolaryngoscopy in experienced anesthetists.

BACKGROUND: Airway management may be difficult in obese patients. Moreover, during prolonged intubation, oxygen desaturation develops rapidly. Videolaryngoscopy improves the view of the larynx, and the Storz® C-MAC™ has been shown to be superior to other videolaryngoscopes in terms of intubation time in obese patients. However, no effort has been made to compare the Storz® C-MAC™ with direct laryngoscopy. The aim of the study was to evaluate if the use of Storz® C-MAC™ may reduce intubation time when compared to direct laryngoscopy (classic Macintosh® blade). METHODS: Eighty patients with Body Mass Index >35 kg/m2 were randomized to orotracheal intubation using either Macintosh® laryngoscope, or the Storz® C-MAC™ with the standard Macintosh blade. Patients had no previous history of a difficult airway. Time-to-intubation (TTI) was defined as the time from the moment anesthetist took the laryngoscope until end-tidal carbon dioxide was detected. RESULTS: No significant difference in TTI could be demonstrated between the two devices tested (mean difference -1.7 s (95% CI:-6.9 to 3.5 s). All patients in the videolaryngoscopy group were successfully intubated with the allocated device, whereas five patients in the direct laryngoscopy group required an alternative device for successful intubation. No significant difference regarding the subjective difficulty of intubation and postoperative sore throat between groups was demonstrated. CONCLUSIONS: In obese patients the airway may be secured equally fast using direct laryngoscopy (Macintosh®) and with videolaryngoscopy using the Stortz® C-MAC™. The risk for failed intubation, however, appears to be greater with direct laryngoscopy, especially in male obese patients.