BMJ Surgery Interventions Health Technologies最新文献

Objectives: We aim to determine what threshold of compressive stress small bowel and colon tissues display evidence of significant tissue trauma during laparoscopic surgery.

Design: This study included 10 small bowel and 10 colon samples from patients undergoing routine gastrointestinal surgery. Each sample was compressed with pressures ranging from 100 kPa to 600 kPa. Two pathologists who were blinded to all study conditions, performed a histological analysis of the tissues. Experimentation: November 2018-February 2019. Analysis: March 2019-May 2020.

Setting: An inner-city trauma and ambulatory hospital with a 40-bed inpatient general surgery unit with a diverse patient population.

Participants: Patients were eligible if their surgery procured healthy tissue margins for experimentation (a convenience sample). 26 patient samples were procured; 6 samples were unusable. 10 colon and 10 small bowel samples were tested for a total of 120 experimental cases. No patients withdrew their consent.

Interventions: A novel device was created to induce compressive "grasps" to simulate those of a laparoscopic grasper. Experimentation was performed ex-vivo, in-vitro. Grasp conditions of 0-600 kPa for a duration of 10 s were used.

Results: Small bowel (10), M:F was 7:3, average age was 54.3 years. Colon (10), M:F was 1:1, average age was 65.2 years. All 20 patients experienced a significant difference (p<0.05) in serosal thickness post-compression at both 500 and 600 kPa for both tissue types. A logistic regression analysis with a sensitivity of 100% and a specificity of 84.6% on a test set of data predicts a safety threshold of 329-330 kPa.

Conclusions: A threshold was discovered that corresponded to both significant serosal thickness change and a positive histological trauma score rating. This "force limit" could be used in novel sensorized laparoscopic tools to avoid intraoperative tissue injury.

Objectives: COVIDTrach is a UK multicentre prospective cohort study project that aims to evaluate the outcomes of tracheostomy in patients with COVID-19 receiving mechanical ventilation and record the incidence of SARS-CoV-2 infection among healthcare workers involved in the procedure.

Design: Data on patient demographic, clinical history and outcomes were entered prospectively and updated over time via an online database (REDCap). Clinical variables were compared with outcomes, with logistic regression used to develop a model for mortality. Participants recorded whether any operators tested positive for SARS-CoV-2 within 2 weeks of the procedure.

Setting: UK National Health Service departments involved in treating patients with COVID-19 receiving mechanical ventilation.

Participants: The cohort comprised 1605 tracheostomy cases from 126 UK hospitals collected between 6 April and 26 August 2020.

Main outcome measures: Mortality following tracheostomy, successful wean from mechanical ventilation and length of time from tracheostomy to wean, discharge from hospital, complications from tracheostomy, reported SARS-CoV-2 infection among operators.

Results: The median time from intubation to tracheostomy was 15 days (IQR 11, 21). 285 (18%) patients died following the procedure. 1229 (93%) of the survivors had been successfully weaned from mechanical ventilation at censoring and 1049 (81%) had been discharged from hospital. Age, inspired oxygen concentration, positive end-expiratory pressure setting, fever, number of days of ventilation before tracheostomy, C reactive protein and the use of anticoagulation and inotropic support independently predicted mortality. Six reports were received of operators testing positive for SARS-CoV-2 within 2 weeks of the procedure.

Conclusions: Tracheostomy appears to be safe in mechanically ventilated patients with COVID-19 and to operators performing the procedure and we identified clinical parameters that are predictive of mortality.

Trial registration number: The study is registered with ClinicalTrials.Gov (NCT04572438).

Objectives: To evaluate functional outcomes following Aquablation in various prostate volume and anatomical subgroups.

Design: A meta-analysis with individual patient data undergoing Aquablation therapy from four prospective, global, clinical studies that have been conducted with Aquablation; WATER, WATER II, FRANCAIS WATER and OPEN WATER.

Setting: Australia, Canada, Lebanon, Germany, New Zealand, UK and the USA.

Participants: 425 men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with 1-year follow-up.

Interventions: Aquablation therapy is an ultrasound guided, robotically executed waterjet ablative procedure for the prostate.

Main outcome measures: The analyses focus International Prostate Symptom Score (IPSS), uroflowmetry, postoperative Incontinence Severity Index (ISI) and surgical retreatment.

Results: 425 men with prostates ranging in size from 20 to 150 mL underwent Aquablation therapy. The outcomes from the seven questions in the IPSS questionnaire were grouped by the following; prostates <100 mL, prostates ≥100 mL, prostate anatomy with an obstructive median lobe identifed by imaging, and prostate anatomy without an obstructive median lobe. Regardless of subgroup, all outcomes are consistent and demonstrate a significant improvement from baseline. Specifically, improvements in frequency, urgency and nocturia demonstrated bladder function improvement. Patients entering treatment with severe incontinence, ISI score >4, and regardless of prostate size, showed a reduction in incontinence during patient follow-up. Surgical retreatment due to BPH symptoms occurred in 0.7% (95% CI 0.1%-2.0%).

Conclusions: Across a variety of prostate anatomies, Aquablation therapy showed remarkable functional improvements following the index procedure. Additionally, men with moderate to severe LUTS/BPH and overactive bladder resulting in urge incontinence showed a reduction in incontinence symptoms postprocedure.

Objectives –: Partial gland ablation (PGA) therapy is an emerging treatment modality that targets specific areas of biopsy proven prostate cancer (PCa) to minimize treatment-related morbidity by sparing benign prostate. This qualitative study aims to explore and characterize perceptions and attitudes toward PGA in men with very-low-risk, low-risk, and favorable intermediate-risk PCa on active surveillance (AS).

Design –: 92 men diagnosed with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS were invited to participate in semi-structured telephone interviews on PGA.

Setting –: Single tertiary care center located in New York City.

Participants –: 20 men with very-low-risk, low-risk, and favorable intermediate-risk PCa on AS participated in the interviews.

Main outcome measures –: Emerging themes on perceptions and attitudes toward PGA were developed from transcripts inductively coded and analyzed under standardized methodology.

Results –: Four themes were derived from twenty interviews that represent the primary considerations in treatment decision-making: (1) the feeling of psychological safety associated with low-risk disease; (2) preference for minimally invasive treatments; (3) the central role of the physician; (4) and the pursuit of treatment options that align with disease severity. Eleven men (55%) expressed interest in pursuing PGA only if their cancer were to progress, while 9 men (45%) expressed interest at the current moment.

Conclusions –: Though an emerging treatment modality, patients were broadly accepting of PGA for PCa with men primarily debating the risks versus benefits of proactively treating low-risk disease. Additional research on men's preferences and attitudes toward PGA will further guide counseling and shared decision-making for PGA.

Objectives: This study aimed to identify a threshold in annual surgeon volume associated with increased risk of revision (for any cause) and deep infection requiring surgery following primary elective total knee arthroplasty (TKA).

Design: A propensity score matched cohort study.

Setting: Ontario, Canada.

Participants: 169 713 persons who received a primary TKA between 2002 and 2016, with 3-year postoperative follow-up.

Main outcome measures: Revision arthroplasty (for any cause), and the occurrence of deep surgical infection requiring surgery.

Results: Based on restricted cubic spline analysis, the threshold for increased probability of revision and deep infection requiring surgery was <70 cases/year. After matching of 51 658 TKA recipients from surgeons performing <70 cases/year to TKA recipients from surgeons with greater than 70 cases/year, patients in the former group had a higher rate of revision (for any cause, 2.23% (95% Confidence Interval (CI) 1.39 to 3.07) vs 1.70% (95% CI 0.85 to 2.55); Hazard Ratio (HR) 1.33, 95% CI 1.21 to 1.47, p<0.0001) and deep infection requiring surgery (1.29% (95% CI 0.44 to 2.14) vs 1.09% (95% CI 0.24 to 1.94); HR 1.33, 95% CI 1.17 to 1.51, p<0.0001).

Conclusions: For primary TKA recipients, cases performed by surgeons who had performed fewer than 70 TKAs in the year prior to the index TKA were at 31% increased relative risk of revision (for any cause), and 18% increased relative risk for deep surgical infection requiring surgery, at 3-year follow-up.

Introduction: Approximately £1130 billion was invested in research worldwide in 2016, and 9.6% of this was on biomedical research. However, about 85% of biomedical research investment is wasted. The Lancet published a series to identify five categories relating to research waste and in 2014. Some categories of research waste in surgery are avoidable by complying with the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework for it enables researchers to design, conduct and report surgical studies robustly and transparently. This review aims to examine the extent to which surgical studies adhered to the IDEAL framework and estimate the amount of overall research waste that could be avoided if compliance was improved.

Methods: We will search for potential studies published in English and between 1 January 2018 and 31 December 2018 via PubMed. Teams of paired reviewers will screen titles, abstracts and full texts independently. Two researchers will extract data from each paper. Data will be collected about general information and specialised information in each stage, and our IDEAL Compliance Appraisal tool will be used to analyse included studies. Descriptive statistics and χ² or Fisher's exact tests for comparisons will be presented.

Discussion: Our study will provide important information about whether compliance with the specific IDEAL Recommendations has reduced research waste in surgical and therapeutic device studies. And we will identify particular key aspects that are worse and need to focus on improving those in future education.

Objectives: To develop an interactive tool that estimates what potential benefits are needed for the robot to provide value for money when compared with endoscopic or open surgical interventions.

Design: A generic online interactive tool was developed to analyze the (health) effects needed to compensate for the additional costs of using a surgical robotic system from a healthcare perspective. The application of the tool is illustrated with a hypothetical new surgical robotic platform. A synthesis of evidence from different sources was used combined with interviews with surgeons.

Setting: Flexible tool that can be adapted to flexible settings.

Participants: Any hospital patient group for which robotic, endoscopic or open surgical procedures may be considered as appropriate treatment alternatives (eg, urology, gynecology, and so on).

Intervention: Robotically assisted surgical interventions.

Comparator: Endoscopic or open surgical interventions.

Main outcome measures: Thresholds of how much (health) effect is needed for robot-assisted surgery to provide value for money and to become cost-effective.

Results: The utilization rate of the surgical robotic system and a reduction in complications appeared to be important aspects in determining the value for money. To become cost-effective, it was deemed important for new surgical robotic systems to have added clinical benefit and become less costly than the current system.

Conclusions: This paper and its assisting interactive tool can be used by clinicians, researchers, and policymakers to gain insight in the benefit needed to provide value for money when using a (new) surgical robotic system or, when the effects are known or can be estimated, to assess the value for money for a specific indication. For robotic surgery to provide most value for money, we recommend assessing for each indication whether the necessary effects seem achievable.

Objectives: The aim of this study was to establish an anatomical index for early prediction of the risk of development of aneurysms in anterior communicating arterial complex (AcomAC). The asymmetric diameter of one anterior cerebral artery (ACA) to other could alter haemodynamics and may contribute to formation of aneurysms in AcomAC and be a reliable predictor of the risk of development of aneurysms.

Design and setting: This is a retrospective, observational and quantitative study, which used cerebral computed tomography angiography (CCTA) scans in South Australia.

Participants: CCTA scans of 166 adult patients of both sexes were studied.

Main outcome measures: The internal diameters of the proximal segments of ACAs (A1s) were measured. Position and presence or absence of aneurysms in AcomAC were determined. The ratio of A1 diameters was taken as a measure of A1 asymmetry.

Results: The ratio of diameters of A1s correlated with the occurrence of AcomAC aneurysms. The risk of development of aneurysms in AcomAC was much greater (80%, OR=47.3) when one A1 segment's radius was at least 50% larger (ie, 2.25 times cross-sectional area) than the other.

Conclusion: The general information on asymmetric A1 has been published previously. The present findings have significant contribution since the A1s asymmetry ratios have been categorised in ascending order and matched with the presence of AcomAC aneurysms. The asymmetry ratio of the A1 is a good predictor for the development of AcomAC aneurysms. Reconstruction of the asymmetric A1 could be done if the technology gets advanced.

Objective: To determine whether patients from the Vascular Quality Initiative (VQI) registry who are Medicare-Medicaid dual-eligible have outcomes after surgical intervention with medical devices such as stents for peripheral artery disease comparable to the outcomes of those eligible for Medicare alone.

Methods: The study cohort included fee-for-service Medicare beneficiaries from 2010 to 2015 who underwent peripheral vascular intervention as determined by the VQI. We performed propensity matching between the dual-eligible and non-dual-eligible cohorts. Postintervention use, including imaging, amputation and death, was determined using Medicare claims data.

Results: Rates of major amputation were higher among dual-eligible patients (13.0% vs 10.5%, p<0.001), while time to amputation by disease severity was similar (p=0.443). For patients with more advanced disease (critical limb ischaemia (CLI) vs claudication), dual-eligible patients have significantly faster times to any amputation and death (p<0.001). For of postoperative imaging, 48.4% of dual-eligible patients receive at least one postoperative image, while the percentage for non-dual-eligible patients is 47.2% (p=0.187).

Conclusions: Patients with mild forms of peripheral artery disease (PAD), such as claudication, demonstrated similar outcomes regardless of dual-eligibility status. However, those with severe PAD, such as CLI, who were also dual-eligible had both inferior overall survival and amputation-free survival. Minimal differences were observed in process-driven aspects of care between dual-eligible and non-dual-eligible patients, including postoperative imaging. These findings indicate that despite receiving similar care, dual-eligible patients with severe PAD have inferior long-term outcomes, suggesting the Medicaid safety net is not timely enough to benefit from long-term outcomes for these patients.