Impact of a digital surgical workflow including Digital Device Briefing Tool on morbidity and mortality in a patient population undergoing primary stapled colorectal anastomosis for benign or malignant colorectal disease: protocol for a multicentre prospective cohort study.

INTRODUCTION: With growing emphasis on surgical safety, it appears fundamental to assess the safety of colorectal resection involving primary stapled anastomosis. Surgical stapling devices can considerably foster patient safety in colorectal surgery, but their misuse or malfunction encompass a unique risk of postoperative complications. The Digital Device Briefing Tool (DDBT) is a digital cognitive aid developed to enhance safe use of the Ethicon circular stapling device during colorectal resection. The purpose of this study is to evaluate how a digital operative workflow, including DDBT, compared with routine surgical care, affects morbidity and mortality in patients undergoing left-sided colorectal resection with primary stapled colorectal anastomosis for colorectal cancer or benign disease. METHODS AND ANALYSIS: A multicentre, prospective cohort study will be conducted at five certified academic colorectal centres in Germany. It compares a non-digital with a Johnson & Johnson digital solution (Surgical Process Institute Deutschland (SPI))-guided operative workflow in patients undergoing left hemicolectomy, sigmoidectomy, anterior rectal resection and Hartmann reversal procedure. The sample size is set at 528 cases in total, divided into 3 groups (a non-digital and two SPI-guided workflow cohorts, with and without DDBT) in a ratio of 1:1:1, with 176 patients each. The primary endpoint is a composite outcome comprising the overall rate of surgical complications, including death, during hospitalisation and within the first 30 days after colorectal resection. Secondary endpoints include operating time, length of hospital stay and 30-day hospital readmission rate. ETHICS AND DISSEMINATION: This study will be performed in line with the Declaration of Helsinki. The ethics committee of the Charité-University Medicine Berlin, Germany, approved the study (No: 22-0277-EA2/060/22). Study Investigators will obtain written informed consent from each patient before a patient may participate in this study. The study results will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: DRKS00029682.

Hidden hazards of SARS-CoV-2 transmission in hospitals: A systematic review.

Despite their considerable prevalence, dynamics of hospital-associated COVID-19 are still not well understood. We assessed the nature and extent of air- and surface-borne SARS-CoV-2 contamination in hospitals to identify hazards of viral dispersal and enable more precise targeting of infection prevention and control. PubMed, ScienceDirect, Web of Science, Medrxiv, and Biorxiv were searched for relevant articles until June 1, 2021. In total, 51 observational cross-sectional studies comprising 6258 samples were included. SARS-CoV-2 RNA was detected in one in six air and surface samples throughout the hospital and up to 7.62 m away from the nearest patients. The highest detection rates and viral concentrations were reported from patient areas. The most frequently and heavily contaminated types of surfaces comprised air outlets and hospital floors. Viable virus was recovered from the air and fomites. Among size-fractionated air samples, only fine aerosols contained viable virus. Aerosol-generating procedures significantly increased (ORair  = 2.56 (1.46-4.51); ORsurface  = 1.95 (1.27-2.99)), whereas patient masking significantly decreased air- and surface-borne SARS-CoV-2 contamination (ORair  = 0.41 (0.25-0.70); ORsurface  = 0.45 (0.34-0.61)). The nature and extent of hospital contamination indicate that SARS-CoV-2 is likely dispersed conjointly through several transmission routes, including short- and long-range aerosol, droplet, and fomite transmission.

Prospective Clinical Study to Evaluate Clinical Performance of a Powered Surgical Stapler in Video-assisted Thoracoscopic Lung Resections.

Video-assisted thoracic surgery (VATS) research often focuses on postoperative air leak, with special consideration for prolonged air leak. There is limited clinical data regarding how stapling devices might affect performance and postoperative outcomes, including air leak. This prospective research evaluates intraoperative and postoperative data associated with VATS, using a new surgical stapling device, in two different geographic regions (the U.S. and Europe). A total of 226 subjects across 10 institutions were enrolled in this study. The primary endpoint was occurrence and duration of postoperative air leaks, including prolonged air leak. Additional data collected included intraoperative details and postoperative outcomes. Prolonged air leak occurred in 22 subjects (10.3%) across procedures (152 lobectomies, 63 wedge resections, and 11 occurrences of wedge resection plus lobectomy). There were no significant differences in occurrence or duration of PAL between the U.S. and Europe. Regional differences were observed for intraoperative leak testing and cartridge selection relative to tissue type. Despite differences in surgical technique between continents, no major or significant difference in air leak or other clinical outcome was detected. Additional research is needed to characterize optimal cartridge selection to tissue properties and how these may potentially impact clinical outcomes.

Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients.

AIM: To analyze the 3-year outcomes of lower body mass index (BMI) (<35 kg/m2) adjustable gastric band (AGB) recipients across multiple sites in the French health insurance system. METHODS: From prospectively collected data on a cohort of 517 morbidly obese Swedish Adjustable Gastric Band® (SAGB) patients (Clinical Trials Web database, #NCT01183975), a retrospective analysis of a subgroup of 29 low-BMI patients was conducted. Patients had a severe obesity-related comorbidity, had undergone a prior bariatric procedure requiring reintervention, or had a maximum adult BMI≥40. Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated. RESULTS: Multiple surgical teams/sites enrolled patients and performed SAGB procedures between September 2, 2007 and April 30, 2008. Of 29 low-BMI patients (mean age, 41.3±10.3 years), 89.7% were female, and obesity duration was 13.6±7.3 years. Mean BMI was 31.5±3.7; there were 37 comorbidities in 15/29 patients. At 3-year follow-up, BMI was 29.4±4.9 (mean change, -2.3±6.2; P=0.069); total cohort EWL, 7.3±74.8%; TBWL, 6.2±18.8%; BMI≥30 to <35 EWL, 38.8±48.0%; there were 7 comorbidities in 15/29 patients (P<0.031). There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years. CONCLUSIONS: In a retrospective analysis of a subgroup of BMI<35 kg/m2 patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.

Stapled hemorrhoidopexy, an innovative surgical procedure for hemorrhoidal prolapse: cost-utility analysis.

AIM: To undertake full economic evaluation of stapled hemorrhoidopexy (PPH) to establish its cost-effectiveness and investigate whether PPH can become cost-saving compared to conventional excisional hemorrhoidectomy (CH). METHODS: A cost-utility analysis in hospital and health care system (UK) was undertaken using a probabilistic, cohort-based decision tree to compare the use of PPH with CH. Sensitivity analyses allowed showing outcomes in regard to the variations in clinical practice of PPH procedure. The participants were patients undergoing initial surgical treatment of third and fourth degree hemorrhoids within a 1-year time-horizon. Data on clinical effectiveness were obtained from a systematic review of the literature. Main outcome measures were the cost per procedure at the hospital level, total direct costs from the health care system perspective, quality adjusted life years (QALY) gained and incremental cost per QALY gained. RESULTS: A decrease in operating theater time and hospital stay associated with PPH led to a cost saving compared to CH of GBP 27 (US $43.11, €30.50) per procedure at the hospital level and to an incremental cost of GBP 33 (US $52.68, €37.29) after one year from the societal perspective. Calculation of QALYs induced an incremental QALY of 0.0076 and showed an incremental cost-effective ratio (ICER) of GBP 4316 (US $6890.47, €4878.37). Taking into consideration recent literature on clinical outcomes, PPH becomes cost saving compared to CH for the health care system. CONCLUSIONS: PPH is a cost-effective procedure with an ICER of GBP 4136 and it seems that an innovative surgical procedure could be cost saving in routine clinical practice.