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OBJECTIVE: To explore how the use of the ProPep® Nerve Monitoring System (ProPep Surgical, Austin, TX, USA) for intraoperative specific sparing of the pudendal nerve fibres influences postoperative functional outcomes after unilateral nerve-sparing (UNS) or non-nerve-sparing (NNS) robot-assisted radical prostatectomy (RARP).PATIENTS AND METHODS: We randomised 100 men undergoing UNS or NNS RARP to ProPep nerve monitoring during RARP (intervention) or standard of care RARP (control). Functional outcomes were assessed at 3, 6, and 12 months using the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), the International Prostate Symptom Score, the Danish Prostate Symptom Score, the International Index of Erectile Function, the Erection Hardness Scale, and 24-h pad tests. The primary outcome was the difference in ICIQ-SF score between the groups at 12 months. Secondary outcomes included differences in the remaining outcome measures and continence rates at all time points. Continence was defined as the use of no pads and the answer 'Never' to the question: 'How often do you experience urinary incontinence?' or a urine loss of <8 g on the 24-h pad test.RESULTS: A total of 82 patients were included in the per-protocol analysis at 12 months with 41 in each group. At 12 months the mean ICIQ-SF scores were 5.37 (95% confidence interval [CI] 3.71-7.03) and 5.66 (95% CI 4.05-7.27) for the intervention and control groups, respectively (P = 0.8). There were no statistically significant differences in any of the remaining outcomes. However, the continence rate was higher in the intervention group at 6 months (63% vs 44%, P = 0.09).CONCLUSIONS: Intraoperative nerve monitoring did not result in better functional outcomes following UNS or NNS RARP. Larger studies are needed to explore if ProPep can reduce the time to continence after RARP.

Background and Aims Guidelines recommend revascularization of intermediate epicardial artery stenosis to be guided by evidence of ischaemia. Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are equally recommended. Individual 5-year results of two major randomized trials comparing FFR with iFR-guided revascularization suggested increased all-cause mortality following iFR-guided revascularization. The aim of this study was a study-level meta-analysis of the 5-year outcome data in iFR-SWEDEHEART (NCT02166736) and DEFINE-FLAIR (NCT02053038).Methods Composite of major adverse cardiovascular events (MACE) and its individual components [all-cause death, myocardial infarction (MI), and unplanned revascularisation] were analysed. Raw Kaplan-Meier estimates, numbers at risk, and number of events were extracted at 5-year follow-up and analysed using the ipdfc package (Stata version 18, StataCorp, College Station, TX, USA).Results In total, iFR and FFR-guided revascularization was performed in 2254 and 2257 patients, respectively. Revascularization was more often deferred in the iFR group [n = 1128 (50.0%)] vs. the FFR group [n = 1021 (45.2%); P = .001]. In the iFR-guided group, the number of deaths, MACE, unplanned revascularization, and MI was 188 (8.3%), 484 (21.5%), 235 (10.4%), and 123 (5.5%) vs. 143 (6.3%), 420 (18.6%), 241 (10.7%), and 123 (5.4%) in the FFR group. Hazard ratio [95% confidence interval (CI)] estimates for MACE were 1.18 [1.04; 1.34], all-cause mortality 1.34 [1.08; 1.67], unplanned revascularization 0.99 [0.83; 1.19], and MI 1.02 [0.80; 1.32].Conclusions Five-year all-cause mortality and MACE rates were increased with revascularization guided by iFR compared to FFR. Rates of unplanned revascularization and MI were equal in the two groups. Structured Graphical Abstract Instantaneous wave-free ratio (iFR) is a non-hyperaemic pressure index measured in the wave-free period in diastole. Fractional flow reserve (FFR) is the ratio between, Funding Agencies|None.

OBJECTIVES: The objective of the present systematic review and meta-analysis was to test the 0-hypothesis of no difference in implant treatment outcome after horizontal alveolar ridge augmentation with xenogenic block compared with autogenous bone block.MATERIAL AND METHODS: A literature search was conducted using PubMed, Embase and Cochrane Library databases in combination with a hand-search of relevant journals until 25 th of January 2022. Comparative and non-comparative studies evaluating horizontal alveolar ridge augmentations with xenogenic blocks were included. Quality and risk of bias were evaluated by Cochrane Collaboration's revised tool and Newcastle-Ottawa scale. RESULTS: Meta-analysis revealed no statistically significant difference in implant survival rate after more than 6 months of functional implant loading (P = 0.71), no difference in alveolar ridge width (P = 0.07) or gain of alveolar ridge width at re-entry (P = 0.13). Non-comparative studies revealed moderate to high short-term implant survival rate and gain in alveolar ridge width, however, complications including dehiscences, graft exposure and graft failure were observed in several studies.CONCLUSIONS: No significant difference could be identified in short-term implant treatment outcome following horizontal alveolar ridge augmentation using xenogenic block compared with autogenous bone block with the limited data available. A high incidence of healing complications and implant failures necessitates further investigation, as well as long-term results on implant survival rate.

Background Supplemental oxygen therapy is central to the treatment of acute hypoxaemic respiratory failure, a condition which remains a major driver for morbidity and mortality in intensive care. Despite several large randomised clinical trials comparing a higher versus a lower oxygenation target for these patients, significant differences in study design impede analysis of aggregate data and final clinical recommendations. Methods This paper presents the protocol for conducting an individual patient data meta-analysis where full individual patient data according to the intention-to-treat principle will be pooled from the HOT-ICU and HOT-COVID trials in a one-step procedure. The two trials are near-identical in design. We plan to use a hierarchical general linear mixed model that accounts for data clustering at a trial and site level. The primary outcome will be 90-day all-cause mortality while the secondary outcome will be days alive without life-support at 90 days. Further, we outline 14 clinically relevant predefined subgroups which we will analyse for heterogeneity in the intervention effects and interactions, and we present a plan for assessing the credibility of the subgroup analyses. Conclusion The presented individual patient data meta-analysis will synthesise individual level patient data from two of the largest randomised clinical trials on targeted oxygen therapy in intensive care. The results will provide a re-analysis of the intervention effects on the pooled intention-to-treat populations and facilitate subgroup analyses with an increased power to detect clinically important effect modifications., Background: Supplemental oxygen therapy is central to the treatment of acute hypoxaemic respiratory failure, a condition which remains a major driver for morbidity and mortality in intensive care. Despite several large randomised clinical trials comparing a higher versus a lower oxygenation target for these patients, significant differences in study design impede analysis of aggregate data and final clinical recommendations. Methods: This paper presents the protocol for conducting an individual patient data meta-analysis where full individual patient data according to the intention-to-treat principle will be pooled from the HOT-ICU and HOT-COVID trials in a one-step procedure. The two trials are near-identical in design. We plan to use a hierarchical general linear mixed model that accounts for data clustering at a trial and site level. The primary outcome will be 90-day all-cause mortality while the secondary outcome will be days alive without life-support at 90 days. Further, we outline 14 clinically relevant predefined subgroups which we will analyse for heterogeneity in the intervention effects and interactions, and we present a plan for assessing the credibility of the subgroup analyses. Conclusion: The presented individual patient data meta-analysis will synthesise individual level patient data from two of the largest randomised clinical trials on targeted oxygen therapy in intensive care. The results will provide a re-analysis of the intervention effects on the pooled intention-to-treat populations and facilitate subgroup analyses with an increased power to detect clinically important effect modifications.

Introduction: According to a precautionary principle, it is recommended that pregnant women and women trying to conceive abstain from alcohol consumption. In this dose–response meta-analysis, we aimed to examine the association between alcohol consumption and binge drinking and the risk of miscarriage in the first and second trimesters. Material and methods: The literature search was conducted in MEDLINE, Embase and the Cochrane Library in May 2022, without any language, geographic or time limitations. Cohort or case–control studies reporting dose-specific effects adjusting for maternal age and using separate risk assessments for first- and second-trimester miscarriages were included. Study quality was assessed using the Newcastle–Ottawa Scale. This study is registered with PROSPERO, registration number CRD42020221070. Results: A total of 2124 articles were identified. Five articles met the inclusion criteria. Adjusted data from 153 619 women were included in the first-trimester analysis and data from 458 154 women in the second-trimester analysis. In the first and second trimesters, the risk of miscarriage increased by 7% (odds ratio [OR] 1.07, 95% confidence interval [CI] 0.96–1.20) and 3% (OR 1.03, 95% CI 0.99–1.08) for each additional drink per week, respectively, but not to a statistically significant degree. One article regarding binge drinking and the risk of miscarriage was found, which revealed no association between the variables in either the first or second trimester (OR 0.84 [95% CI 0.62–1.14] and OR 1.04 [95% CI 0.78–1.38]). Conclusions: This meta-analysis revealed no dose-dependent association between miscarriage risk and alcohol consumption, but further focused research is recommended. The research gap regarding miscarriage and binge drinking needs further investigation.

Objective: This study aimed to investigate the validity of simulation-based assessment of robotic-assisted cardiac surgery skills using a wet lab model, focusing on the use of a time-based score (TBS) and modified Global Evaluative Assessment of Robotic Skills (mGEARS) score. Methods: We tested 3 wet lab tasks (atrial closure, mitral annular stitches, and internal thoracic artery [ITA] dissection) with both experienced robotic cardiac surgeons and novices from multiple European centers. The tasks were assessed using 2 tools: TBS and mGEARS score. Reliability, internal consistency, and the ability to discriminate between different levels of competence were evaluated. Results: The results demonstrated a high internal consistency for all 3 tasks using mGEARS assessment tool. The mGEARS score and TBS could reliably discriminate between different levels of competence for the atrial closure and mitral stitches tasks but not for the ITA harvesting task. A generalizability study also revealed that it was feasible to assess competency of the atrial closure and mitral stitches tasks using mGEARS but not the ITA dissection task. Pass/fail scores were established for each task using both TBS and mGEARS assessment tools. Conclusions: The study provides sufficient evidence for using TBS and mGEARS scores in evaluating robotic-assisted cardiac surgery skills in wet lab settings for intracardiac tasks. Combining both assessment tools enhances the evaluation of proficiency in robotic cardiac surgery, paving the way for standardized, evidence-based preclinical training and credentialing. Clinical trial registry number: NCT05043064.

BACKGROUND: It is controversial whether extensive resection of right-sided colon cancer confers oncological benefits. OBJECTIVE: The aim of this study was to evaluate short- and long-term outcomes of extended surgical removal of the mesocolon compared to the conventional approach. DESIGN: This was a retrospective population-based study. SETTING: Study is based on a prospectively maintained Danish Colorectal Cancer Group database. MAIN OUTCOME MEASURES: Primary outcome measures included local-regional recurrence in patients who underwent curative resection for right-sided colon cancer and 30-day postoperative complications. Distant metastasis, unplanned intraoperative adverse events, and 30- and 90-day postoperative mortality were also investigated. Patients who had palliative or compromised resection, emergency surgery, or neoadjuvant chemotherapy were excluded. RESULTS: Of the 12,855 patients with resection of right-sided colon cancer retrieved, 1151 underwent extended right hemicolectomy. Patients who had extended right hemicolectomy were younger males with lower ASA scores, were operated on by colorectal surgeons using a laparoscopic approach, and had a significantly higher number of harvested lymph nodes. The rate of local-regional recurrence was 1.1% (136/12,855), with no difference between conventional right hemicolectomy and extended right hemicolectomy (OR, 1.7; 95% CI, 0.63–2.18). Postoperative medical complications were significantly higher in extended right hemicolectomy even after adjusting for age, comorbidity, access to the abdomen, and other covariates (OR, 1.26; 95% CI, 1.01–1.58). No significant difference was noticed between conventional right hemicolectomy and extended right hemicolectomy in the rates of distant metastasis, unplanned intraoperative adverse events, and mortality. LIMITATIONS: Because it is a register-based study, underreporting cannot be exclud, BACKGROUND: It is controversial whether extensive resection of right-sided colon cancer confers oncological benefits. OBJECTIVE: The aim of this study was to evaluate short- and long-term outcomes of extended surgical removal of the mesocolon compared to the conventional approach. DESIGN: This was a retrospective population-based study. SETTING: Study is based on a prospectively maintained Danish Colorectal Cancer Group database. MAIN OUTCOME MEASURES: Primary outcome measures included local-regional recurrence in patients who underwent curative resection for right-sided colon cancer and 30-day postoperative complications. Distant metastasis, unplanned intraoperative adverse events, and 30- and 90-day postoperative mortality were also investigated. Patients who had palliative or compromised resection, emergency surgery, or neoadjuvant chemotherapy were excluded. RESULTS: Of the 12,855 patients with resection of right-sided colon cancer retrieved, 1151 underwent extended right hemicolectomy. Patients who had extended right hemicolectomy were younger males with lower ASA scores, were operated on by colorectal surgeons using a laparoscopic approach, and had a significantly higher number of harvested lymph nodes. The rate of local-regional recurrence was 1.1% (136/12,855), with no difference between conventional right hemicolectomy and extended right hemicolectomy (OR, 1.7; 95% CI, 0.63-2.18). Postoperative medical complications were significantly higher in extended right hemicolectomy even after adjusting for age, comorbidity, access to the abdomen, and other covariates (OR, 1.26; 95% CI, 1.01-1.58). No significant difference was noticed between conventional right hemicolectomy and extended right hemicolectomy in the rates of distant metastasis, unplanned intraoperative adverse events, and mortality. LIMITATIONS: Because it is a register-based study, underreporting cannot be excluded. Extended right hemicolectomy, as defined in this study, does not reflect the exten

Introduction: Comparing imaging examinations with those previously obtained is considered mandatory in imaging guidelines. To our knowledge, no studies are available on neither the influence, nor the sequence, of prior imaging and reports on diagnostic accuracy using biopsy as the reference standard. Such data are important to minimize diagnostic errors and to improve the preparation of diagnostic imaging guidelines. The aim of our study was to provide such data. Materials and methods: A retrospective cohort of 216 consecutive skeletal biopsies from patients with at least 2 different imaging modalities (X-ray, CT and MRI) performed within 6 months of biopsy was identified. The diagnostic accuracy of the individual imaging modality was assessed. Finally, the possible influence of the sequence of imaging modalities was investigated. Results: No significant difference in the accuracy of the imaging modalities was shown, being preceded by another imaging modality or not. However, the sequence analyses indicate sequential biases, particularly if MRI was the first imaging modality. Conclusion: The sequence of the imaging modalities seems to influence the diagnostic accuracy against a pathology reference standard. Further studies are needed to establish evidence-based guidelines for the strategy of using previous imaging and reports to improve diagnostic accuracy.