Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial.

INTRODUCTION: Atrial fibrillation (AF) is an independent predictor of adverse outcomes in patients with hypertrophic cardiomyopathy (HCM). Although catheter ablation is highly recommended for general AF populations, it is less effective in maintaining sinus rhythm in patients with HCM associated with AF. Hybrid ablation, combining a cosmetic approach with a lower rate of AF relapse, lacks comparative studies to verify its efficacy against CA in HCM. This study aims to assess the rhythm control effectiveness of hybrid versus CA in non-obstructive HCM (non-oHCM) patients with AF. METHODS/ANALYSIS: This prospective, multicentre, randomised trial involves a blinded assessment of outcomes in non-oHCM patients with non-paroxysmal AF. Sixty-six candidates from three centres will be randomised 1:1 to either hybrid or CA, including isthmus addressed lesion sets. Participants will be stratified by left atrial (LA) size (LA diameter ≤50 mm or >50 mm). Follow-ups at the 3rd, 6th and 12th months will evaluate the primary endpoint of freedom from documented atrial tachycardia lasting over 30 s within 12 months post-procedure without antiarrhythmic drugs, along with secondary endpoints of all-cause mortality, cardiovascular-related mortality, cerebral stroke, peripheral vascular embolism, heart failure-related rehospitalisation, all-cause rehospitalisation and quality of life assessments. ETHICS AND DISSEMINATIONAPPROVAL: The central ethics committee at Fuwai Hospital has approved the Hypertrophic CardioMyopathy with Atrial Fibrillation trial (approval number: 2022-1736). Results will be disseminated through publications in peer-reviewed journals and presentations at conferences. TRIAL REGISTRATION NUMBER: NCT05610215.

Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis.

PURPOSE: To determine the effectiveness of virtual reality (VR) on preoperative anxiety in adult patients. DESIGN: A systematic review and meta-analysis of randomized controlled trials. METHODS: A systematic search was carried out using PubMed, Web of Science, the Cochrane Library, Embase, CINAHL, Scopus, PsycINFO, China National Knowledge Infrastructure (CNKI), WANFANG DATA, Chinese Science and Technology Periodical Database (VIP), and Sino-Med from inception to December 18, 2022. All eligible randomized controlled trials published were included (published in English and Chinese). The Cochrane Collaboration "Risk of Bias" tool was used to assess the methodological quality of the included studies. Review Manager software 5.4 was used for data analysis. FINDINGS: Nine studies with sample sizes ranging from 72 to 255 and 1,046 participants were identified. The results of the meta-analysis showed that VR significantly reduced preoperative anxiety in adults (standardized mean difference = -0.48, 95% CI: -0.93 to -0.03, P = .04). Our results suggested that VR improved postoperative satisfaction scores more effectively compared with control care (mean difference = 15.29, 95% CI: 6.25 to 24.33, P = .0009). CONCLUSIONS: Study results support that VR has a positive effect in reducing preoperative anxiety in adults. VR can also significantly improve patients' satisfaction after surgery. However, the results need to be further assessed due to the small sample sizes and high heterogeneity.

Gaining consensus on a protocol for general surgery physician assistants in the management of non-compressible abdominal haemorrhage in military austere environments: a Delphi study.

BACKGROUND: Non-compressible abdominal haemorrhage (NCAH) is a potentially preventable cause of death due to injury. Limited exploratory laparotomy by a non-surgeon is a temporary intervention to sustain life until definitive surgical intervention by trauma surgeons can be obtained. This study aims to establish consensus on a protocol for general surgery physician assistants performing limited exploratory laparotomy to manage NCAH in an austere environment. METHOD: This study included anonymised trauma surgeons and general surgery physician assistants from military and civilian backgrounds. Participants were recruited from various professional surgical organisations, including direct interaction with trauma surgeons and surgical physician assistants. Participants used a modified Delphi survey with a 9-point Likert scale in two rounds. The two surveys were categorised into three parts: protocol for NCAH (part A), the potential role of general surgery physician assistants (part B) and measures of success (part C). A total of 24 statements were voted on and assessed. Votes were divided into three zones: agreement (median 7-9), uncertain (median 4-6) and disagreement (median 1-3). To reach a consensus, 70% agreement was required within a zone. If more than 30% of the votes fell outside of a specific zone, consensus was not achieved. After consensus, the original protocol was revised in an online meeting with experts. RESULTS: The initial analysis involved 29 participants. After 2 survey rounds, 19 out of 24 statements reached a consensus. Part A: 10 statements gained consensus, including in austere environments, controlling NCAH can be challenging. A qualified general surgery physician assistant should intervene. A focused assessment with sonography for trauma examination can be used for screening. Bleeding can be managed with packing and pressure. After managing the haemorrhage, the abdominal wall should be left open with a temporary closure technique. Part B: nine statements gained consensus, including in austere locations, a licensed general surgery physician assistant with a minimum of 3 years of experience working under the supervision of a trauma/general surgeon can perform interventions for limited exploratory laparotomy for patients with NCAH. Part C: general surgery physician assistants will be required to have the same success rates as any qualified surgeon. CONCLUSION: Gaining consensus and implementing a revised protocol for managing NCAH by general surgery physician assistants is attainable. General surgery physician assistants will need formal training to manage NCAH. With the support of trauma surgeons who provide direct and indirect supervision, general surgery physician assistants can develop a comprehensive understanding of the necessary skills and make sound decisions when treating patients with this condition. This teamwork can also increase surgical capacity and potentially decrease mortality rates for patients with NCAH in austere environments.

Analysis of emergency resuscitative thoracotomy in the combat setting.

INTRODUCTION: Emergency resuscitative thoracotomy (ERT) is a resource-intensive procedure that can deplete a combat surgical team's supply and divert attention from casualties with more survivable injuries. An understanding of survival after ERT in the combat trauma population will inform surgical decision-making. METHODS: We requested all encounters from 2007 to 2023 from the Department of Defense Trauma Registry (DoDTR). We analysed any documented thoracotomy in the emergency department and excluded any case for which it was not possible to distinguish ERT from operating room thoracotomy. The primary outcome was 24-hour mortality. RESULTS: There were 48 301 casualties within the original dataset. Of those, 154 (0.3%) received ERT, with 114 non-survivors and 40 survivors at 24 hours. There were 26 (17%) survivors at 30 days. The majority were performed in role 3. The US military made up the largest proportion among the non-survivors and survivors. Explosives predominated in both groups (61% and 65%). Median Composite Injury Severity Scores were lower among the non-survivors (19 vs 33). Non-survivors had a lower proportion of serious head injuries (13% vs 40%) and thorax injuries (32% vs 58%). Median RBC consumption was lower among non-survivors (10 units vs 19 units), as was plasma (6 vs 16) and platelets (0 vs 3). The most frequent interventions and surgical procedures were exploratory thoracotomy (n=140), chest thoracostomy (n=137), open cardiac massage (n=131) and closed cardiac massage (n=121). CONCLUSION: ERT in this group of combat casualties resulted in 26% survival at 24 hours. Although this proportion is higher than that reported in civilian data, more rigorous prospective studies would need to be conducted or improvement in the DoDTR data capture methods would need to be implemented to determine the utility of ERT in combat populations.

Cohort profile: study design and baseline characteristics of an observational longitudinal weight loss cohort and biorepository of patients undergoing sleeve gastrectomy in the USA.

PURPOSE: We developed a comprehensive sleeve gastrectomy (SG) weight loss study cohort and biorepository to uncover mechanisms, biomarkers and predictive factors of weight loss, weight maintenance and amelioration of obesity-related comorbidities. For this purpose, we collected psychosocial, anthropometric, clinical data and a variety of samples pre-surgery, intraoperatively and 1.5, 3, 12 and 24 months post-surgery. For longer-term assessment, the collection of psychosocial and anthropometric data was extended to 10 years. Here, we present in-depth characterisation of the cohort and detailed overview of study procedures as a foundation for future analyses. PARTICIPANTS: We consented 647 participants between June 2017 and March 2020 from two bariatric surgery clinics in New York City-one major urban hospital and one private hospital. Of 355 participants who provided baseline data, 300 underwent SG. Of these, 79% are females with an average age of 38 years, 68% are Hispanic, 20% are non-Hispanic Black and 11% are non-Hispanic White. FINDINGS TO DATE: We collected intraoperative adipose and stomach tissues from 282 patients and biosamples (blood, urine, saliva, stool) from 245 patients at 1.5 months, 238 at 3 month, 218 at 12 months and 180 at 24 months post-surgery. We are currently collecting anthropometric and psychosocial data annually until 10 years post-surgery. Data analysis is currently underway. FUTURE PLANS: Our future research will explore the variability in weight loss outcomes observed in our cohort, particularly among Black and Hispanic patients in comparison to their White counterparts. We will identify social determinants of health, metabolic factors and other variables that may predict weight loss success, weight maintenance and remission of obesity-related comorbidities. Additionally, we plan to leverage our biorepository for collaborative research studies. We will complete long-term follow-up data by December 2031. We plan to apply for funding to expand biosample collection through year 10 to provide insights into the mechanisms of long-term weight maintenance.

Mapping cognitive biases in multidisciplinary team (MDT) decision-making for cancer care in Scotland: a cognitive ethnography study protocol.

INTRODUCTION: The efficiency of multidisciplinary teams (MDTs) in cancer care hinges on facilitating clinicians' cognitive processes as they navigate complex and uncertain judgements during treatment planning. When systems and workflows are not designed to adequately support human judgement and decision-making, even experts are prone to fallible reasoning due to cognitive biases. Incomplete integration of information or biased interpretations of patient data can lead to clinical errors and delays in the implementation of treatment recommendations. Though their impact is intuitively recognised, there is currently a paucity of empirical work on cognitive biases in MDT decision-making. Our study aims to explicate the impact of such biases on treatment planning and establish a foundation for targeted investigations and interventions to mitigate their negative effects. METHODS AND ANALYSIS: This is a qualitative, observational study. We employ cognitive ethnography, informed by the Distributed Cognition for Teamwork framework to assess and evaluate MDT decision-making processes. The study involves in-person and virtual field observations of hepatopancreaticobiliary and upper gastrointestinal MDTs and interviews with their members over several months. The data generated will be analysed in a hybrid inductive/deductive fashion to develop a comprehensive map of potential cognitive biases in MDT decision processes identifying antecedents and risk factors of suboptimal treatment planning processes. Further, we will identify components of the MDT environment that can be redesigned to support decision-making via development of an MDT workspace evaluation tool. ETHICS AND DISSEMINATION: This project has received management and ethical approvals from NHS Lothian Research and Development (2023/0245) and the University of Edinburgh Medical School ethical review committee (23-EMREC-049). Findings will be shared with participating MDTs and disseminated via a PhD thesis, international conference presentations and relevant scientific journals.

Predicting risk factors for acute pain after hepatobiliary and pancreatic surgery: an observational case control study.

BACKGROUND: Inadequate postoperative analgesia is associated with increased risks of various postoperative complications, longer hospital stay, decreased quality of life and higher costs. OBJECTIVES: This study aimed to investigate the risk factors for moderate-to-severe postoperative pain within the first 24 hours and 24-48 hours after major hepatobiliary pancreatic surgery. METHODS: Data of patients who underwent surgery at the Department of Hepatobiliary Surgery in Henan Provincial People's Hospital were collected from January 2018 to August 2020. Univariate and multivariate logistic regression analyses were used to identify the risk factors of postoperative pain. RESULTS: In total, 2180 patients were included in the final analysis. 183 patients (8.4%) suffered moderate-to-severe pain within 24 hours after operation. The independent risk factors associated with moderate-to-severe pain 24 hours after procedures were younger age (OR, 0.97; 95% CI 0.95 to 0.98, p<0.001), lower body mass index (BMI) (OR, 0.94; 95% CI 0.89 to 0.98, p=0.018), open surgery (OR, 0.34; 95% CI 0.22 to 0.52, p<0.001), and postoperative analgesia protocol with sufentanil (OR, 4.38; 95% CI 3.2 to 5.99, p<0.001). Postoperative hospital stay was longer in patients with inadequate analgesia (p<0.05). CONCLUSION: Age, BMI, laparoscopic surgery, and different analgesic drugs were significant predictors of postoperative pain after major hepatobiliary and pancreatic surgery. TRIAL REGISTRATION: ChiCTR2100049726.

Preventing retraumatisation in torture survivors during surgical care: results of a guideline-development project and qualitative study exploring healthcare providers' experiences.

OBJECTIVES: Insufficient training and the absence of guidelines increase the risk of retraumatisation in torture survivors during surgical procedures. This study aims to develop guidelines to mitigate this risk and gather healthcare professionals' experiences treating torture survivors and insights on the guideline's feasibility and acceptability. DESIGN: The study was conducted in two phases. Phase 'a' involved developing guidelines based on reviews of torture survivors' encounters in somatic care and potential retraumatisation triggers, as well as a qualitative study on survivors' experiences during surgical interventions. The development process adhered to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) principles and the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument for methodological rigour. Phase 'b' involved focus groups and individual interviews with healthcare professionals to explore challenges in caring for torture survivors and to evaluate the guidelines. SETTING: The study, conducted from May to August 2023, involved participants from surgical departments in three hospitals in southern and southeastern Norway. PARTICIPANTS: Twenty-one healthcare professionals, including surgeons, anaesthesiologists, nurses and a dentist, participated in the study. Both focus group interviews and individual interviews were conducted. RESULTS: Phase 'a': guidelines comprising six sections were developed: an introduction, general guidelines and four sections covering the preoperative, perioperative and postoperative surgical stages. Phase 'b': healthcare professionals struggled to understand torture's complexities and identify survivors' unique needs. They faced challenges using interpreters and assisting patients with strong reactions. While the guidelines were viewed as practical and useful for raising awareness, their length was questioned. CONCLUSIONS: We provide recommendations for preventing retraumatisation in torture survivors undergoing surgical treatment. The guidelines may serve as a starting point for offering safe and individualised care to torture survivors. Teaching institutions and hospitals may incorporate the guidelines into healthcare professionals' education.

Psychosocial outcomes following emergency laparotomy (POLO) study: a study protocol for a multicentre mixed-methods prospective cohort study assessing the psycho-social outcomes following emergency laparotomy in adults.

INTRODUCTION: Morbidity from an emergency laparotomy (EmLap) is difficult to define and poorly understood. Morbidity is a holistic concept, reliant upon an interplay of bio-psychosocial outcomes that evolve long after discharge. To date, no previous study has explored the psychosocial outcomes following EmLap as a collective, nor their change over time. This study aims to describe the holistic morbidity following EmLap within the first year following surgery. METHODS AND ANALYSIS: This is a multicentre, mixed-methods prospective 12-month cohort study with two participant populations: patient participants and family caregivers (FCGs). A target of 160 adult patients who undergo EmLap and can give informed consent will be included in the patient participant group. Patient participants will be asked to complete three patient surveys, incorporating validated patient-reported outcome measures (PROMs) to assess bio-psychosocial outcomes (EuroQol five-dimension five-level (EQ5D-5L), Gastrointestinal Quality Life Index-36, Patient Health Questionnaire-9, Generalised Anxiety Disorder 7, International Trauma Questionnaire, Caregiver Interaction Scale and Fatigue Severity Scale) in the 12 months following surgery. A subgroup of 15 patient participants will be asked to take part in two semistructured interviews at 6 and 12 months. A target of 15 associated family caregivers will be included in the FCG group. FCGs will be asked to take part in a semi-structured interview at 6 months to assess the EmLap impact on the wider support network. The primary outcome will be a change in quality of life (EQ5D-5L) at 12 months. Secondary outcomes will be changes in bio-psychosocial status at 3 and 12 months. Qualitative analysis will allow contextualisation of PROMS and further explore themes of EmLap morbidity. It is anticipated that the results of this study will help inform and develop standards of aftercare for future EmLap patients. ETHICS AND DISSEMINATION: This study has received ethical approval (Wales REC7;12/WA/0297) and will be undertaken in accordance with the principles of Good Clinical Practice. We intend to disseminate study results in peer-reviewed journals and medical conferences, as well as a lay report to study participants. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT05281627.

Development of a core data set for describing, measuring and reporting the learning curve in studies of novel invasive procedures: study protocol.

INTRODUCTION: The introduction of novel surgical techniques and procedures remains poorly regulated and standardised. Although the learning curve associated with invasive procedures is a critical part of innovation, it is currently inconsistently defined, measured and reported. This study aims to develop a core data set that can be applied in all studies describing or measuring the learning curve in novel invasive procedures. METHODS: A core data set will be developed using methods adapted from the Core Outcome Measures in Effectiveness Trials initiative. The study will involve three phases: (1) Identification of a comprehensive list of data items through (a) an umbrella review of existing systematic reviews on the learning curve in surgery and (b) qualitative interviews with key stakeholders. (2) Key stakeholders (eg, clinical innovators, clinicians, patients, methodologists, statisticians, journal editors and governance representatives) will complete a Delphi survey to score the importance of each data item, generating a shortened list. (3) Consensus meeting(s) with stakeholders to discuss and agree on the final core data set. ETHICS AND DISSEMINATION: The study is approved by an Institutional Ethics Committee at the University of Bristol (ref: 111362). Participants will complete written informed consent to participate. Dissemination strategies include scientific meeting presentations, peer-reviewed journal publications, patient engagement events, use of social media platforms, workshops and other events.

Defining the gaps in transitional care to adulthood for patients in paediatric surgical specialties: a scoping review protocol.

INTRODUCTION: Transitioning patients from their paediatric centres to adulthood is an important subject for many of these patients living with different chronic pathologies. There are few studies that assess its effectiveness in paediatric surgical pathologies. The overall objective of this scoping review is to assess the extent of the literature describing transitional programmes dedicated to young patients living with surgical conditions. The primary question will look to assess what transitional programmes are available for young patients living with surgical conditions either operated or not. METHODS AND ANALYSIS: The proposed scoping review will follow guidelines described by the Joanna Briggs Institute manual described by Peters et al in 2020. This protocol will employ the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols checklist. The concept that will be included in this review is the exposure of these patients to a transition of care pathway or care programmes. Patients between the ages of 16 and 30 with a surgical condition will be included. There will be no comparator. No specific outcomes will be assessed, however, the outcomes that will be found from the transition programmes will be reviewed. A knowledge synthesis librarian will search MEDLINE All (Ovid), Embase (Ovid), Web of Science Core Collection (Clarivate) and CINAHL Complete (EBSCOhost). The literature search will be limited to 2000 onwards publications. No language or age group limitation will be applied. The reference list of all included sources of evidence will be screened for additional studies. Screening of search results and data extraction from included studies will be completed in Covidence by two independent reviewers. We will also use the PAGER (Patterns, Advances, Gaps, Evidence for practice and Research recommendations) framework to report and summarise the results. ETHICS AND DISSEMINATION: This review does not require ethics approval. Our dissemination strategy includes peer review publication, conference presentation, co-constructed guidelines with stakeholders and policymakers. TRIAL REGISTRATION: This review is registered on OSF.

Hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery (TRACTION): protocol for a phase IV randomised controlled trial.

INTRODUCTION: Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk. METHODS AND ANALYSIS: A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention. ETHICS AND DISSEMINATION: Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: NCT04803747.

Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population.

PURPOSE: Postoperative complications increase mortality, disability and costs. Advanced understanding of the risk factors for postoperative complications is needed to improve surgical outcomes. This paper discusses the rationale and profile of the BIGPROMISE (biomarkers to guide perioperative management and improve outcome in high-risk surgery) cohort, that aims to investigate risk factors, pathophysiology and outcomes related to postoperative complications. PARTICIPANTS: Adult patients undergoing major surgery in two tertiary teaching hospitals. Clinical data and blood samples are collected before surgery, at the end of surgery and on the first, second and third postoperative day. At each time point a panel of cardiovascular, inflammatory, renal, haematological and metabolic biomarkers is assessed. Aliquots of plasma, serum and whole blood of each time point are frozen and stored. Data on severe complications are prospectively collected during 30 days after surgery. Functional status is assessed before surgery and after 120 days using the WHO Disability Assessment Schedule (WHODAS) 2.0. Mortality is followed up until 2 years after surgery. FINDINGS TO DATE: The first patient was enrolled on 8 October 2021. Currently (1 January 2024) 3086 patients were screened for eligibility, of whom 1750 (57%) provided informed consent for study participation. Median age was 66 years (60; 73), 28% were female, and 68% of all patients were American Society of Anaesthesiologists (ASA) physical status class 3. Most common types of major surgery were cardiac (49%) and gastro-intestinal procedures (26%). The overall incidence of 30-day severe postoperative complications was 16%. FUTURE PLANS: By the end of the recruitment phase, expected in 2026, approximately 3000 patients with major surgery will have been enrolled. This cohort allows us to investigate the role of pathophysiological perioperative processes in the cause of postoperative complications, and to discover and develop new biomarkers to improve risk stratification for adverse postoperative outcomes. TRIAL REGISTRATION NUMBER: NCT05199025.

Patterns of anatomical injury and anaesthesia procedures in wounded Ukrainian soldiers from Anti-Terrorist Operation/Operation Joint Forces: 2014-2021.

INTRODUCTION: The study aims to analyse the causes and anatomical patterns of explosive and gunshot wounds in Ukrainian soldiers acquired during the Anti-Terrorist Operation/Operation Joint Forces. We also investigated how general and regional anaesthesia procedures affected post-operative pain in wounded soldiers. METHODS: A retrospective observational study was done based on the medical records of Ukrainian soldiers wounded in the Anti-Terrorist Operation/Operation Joint Forces between 2014 and 2021. The collected data included the American Society of Anesthesiologists score, mechanism of injury, the pattern of anatomical injury, pain intensity and the choice of anaesthesia given. Pain intensity was diagnosed using a Numerical Rating Scale. RESULTS: A total of 280 combat casualties with explosive (75.7%) and gunshot (24.3%) wound injuries were included in the study. Most of the wounded soldiers had one body region affected by injury (59.3%). In most of the cases, the affected body regions were lower (48.2%) and upper (33.8%) limbs. In 62.5% of patients, regional anaesthesia was used, while general anaesthesia was used in 37.5% of cases. The pain significantly decreased after initial treatment at the field medical unit regardless of the anaesthesia type or the number of affected body regions. CONCLUSION: Understanding the sources and anatomical patterns of war-related injuries in recent conflicts is an important element in reducing the mortality and suffering of wounded soldiers. The high percentage of injured extremities in our cohort emphasises the importance of regional anaesthesia in contemporary wars.

Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY).

BACKGROUND: Post-induction anaesthesia often promotes intraoperative hypotension (IOH) that can worsen postoperative outcomes. This study aims to assess the benefit of norepinephrine versus ephedrine at the induction of anaesthesia to prevent postoperative complications following major abdominal surgery by preventing IOH. METHODS AND ANALYSIS: The EPON STUDY is a prospective single-centre randomised controlled trial with the planned inclusion of 500 patients scheduled for major abdominal surgery at the Amiens University Hospital. The inclusion criteria are patients aged over 50 years weighing more than 50 kg with an American Society of Anesthesiologists physical status score of ≥2 undergoing major abdominal surgery under general anaesthesia. Patients are allocated either to the intervention group (n=250) or the standard group (n=250). In the intervention group, the prevention of post-induction IOH is performed with norepinephrine (dilution to 0.016 mg/mL) using an electric syringe pump at a rate of 0.48 mg/h (30 mL/h) from the start of anaesthesia and then titrated to achieve the haemodynamic target. In the control group, the prevention of post-induction IOH is performed with manual titration of ephedrine, with a maximal dose of 30 mg, followed by perfusion with norepinephrine. In both groups, the haemodynamic target to maintain is a mean arterial pressure (MAP) of 65 mm Hg or 70 mm Hg for patients with a medical history of hypertension. An intention-to-treat analysis will be performed. The primary outcome is the Clavien-Dindo score assessed up to 30 days postoperatively. The secondary endpoints are the length of hospital stay and length of stay in an intensive care unit/postoperative care unit; postoperative renal function; postoperative cardiovascular, respiratory, neurological, haematological and infectious complications at 1 month; and volume of intraoperative vascular filling and mortality at 1 month. ETHICS AND DISSEMINATION: Ethical approval was obtained from the committee of protection of the persons of Ile de France in May 2021 (number 21 05 41). The authors will be involved in disseminating the research findings (through attending conferences and co-authoring papers). The results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05276596.

Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study.

OBJECTIVES: Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery. DESIGN: Prospective observational cohort study. SETTING: 12 National Health Service centres in England. PARTICIPANTS: Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation. PRIMARY AND SECONDARY OUTCOME MEASURES: Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band. RESULTS: In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (-9.5%, 95% CI -14.3% to -4.8% p<0.001) and depression (-22.3%, 95% CI -27.0% to -17.6% p<0.001). CONCLUSIONS: Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year. TRIAL REGISTRATION NUMBER: NCT02841527 and ISRCTN00786323.

Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial.

INTRODUCTION: Hysterectomy is the most common surgical procedure in the field of gynaecology. The traditional multiport laparoscopy, transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy approaches have been implemented to varying degrees in clinical practice. At present, although their feasibility has been proven, there are no large randomised controlled studies on postoperative rehabilitation. This study aims to evaluate postoperative recovery and assess the safety and effectiveness of these three surgical approaches for total laparoscopic hysterectomy. METHOD AND ANALYSIS: This is a multicentre, randomised, single-blind, three-arm, parallel-group, interventional clinical trial. Recruitment will be carried out in five tertiary hospitals in China. Patients diagnosed with benign uterine disease or precancerous lesions will be assigned to the vNOTES group, TU-LESS group and conventional laparoscopy group at a 1:1:1 ratio. The achievement rate of comprehensive indices of enhanced recovery after surgery (ERAS) within 24 hours postoperatively will be considered the primary outcome (the comprehensive indicators of ERAS include fluid intake, passing flatus, urination after catheter removal, ambulation and a Visual Analogue Scale score ≤3.) This study will use a non-inferiority test, with a power (1-ß) of 80% and a margin of -0.15, at a one-sided α of 0.0125. The sample size will be 480 patients (including an assumed 15% dropout rate), calculated according to the primary outcome. ETHICS AND DISSEMINATION: This study was approved on 25 April 2022 by the Medical Ethics Committee of West China Second University Hospital (2022(057)), Sichuan University, Chengdu, China. All participants will be required to provide informed consent before their participation in the study. The results of the trial will be submitted for publication in a peer-reviewed journal and presented at international conferences. PROTOCOL VERSION: V.3.0, 31 August 2023. TRIAL REGISTRATION NUMBER: ChiCTR2200057405.

Robotic beyond total mesorectal excision (TME) for locally advanced or recurrent rectal cancer: a systematic review protocol.

INTRODUCTION: The surgical treatment for locally advanced or recurrent rectal cancer requires oncological clearance with a pelvic exenteration or a beyond total mesorectal excision (TME). The aim of this systematic review is to explore the safety and feasibility of robotic surgery in locally advanced and recurrent rectal cancer by evaluating perioperative outcomes, oncological clearance rates, and survival and recurrence rates postrobotic beyond TME surgery. METHODS: The systematic review will include studies published until the end of December 2023. The MEDLINE, EMBASE and Scopus databases will be searched. The screening process, study selection, data extraction, quality assessment and analysis will be performed by two independent reviewers. Discrepancies will be resolved by consensus with a third independent reviewer. The risk of bias will be assessed with validated scores. The primary outcomes will be oncological clearance, overall and disease-free survival, and local and systemic recurrence rates post robotic or robot-assisted beyond TME surgery for locally advanced or recurrent rectal cancer. Secondary outcomes will include perioperative outcomes. ETHICS AND DISSEMINATION: No ethical approval is required for this systematic review as no individual patient cases are studied requiring access to individual medical records. The results of the systematic review will be disseminated with conference presentations and peer-reviewed paper publications. PROSPERO REGISTRATION OF THE STUDY: CRD42023408098.

Optimal concentration of ropivacaine for peripheral nerve blocks in adult patients: a protocol for systematic review and meta-analysis.

INTRODUCTION: Ropivacaine is the most widely used local anaesthetic for peripheral nerve blocks (PNBs). The effects of various concentrations of ropivacaine in PNB have been investigated and compared by many randomised controlled trials (RCTs). This protocol aims to identify the optimal concentration of ropivacaine for PNB in adult patients. METHODS AND ANALYSIS: PubMed, EMBASE, the Cochrane library and Web of Science will be searched from their inception to 10 July 2023. RCTs that compare the analgesic effects of different concentrations of ropivacaine for PNB will be included. Retrospective studies, meta-analyses, reviews, case reports, letters, conference abstracts and paediatric studies will be excluded. The duration of analgesia will be named as the primary outcome. Secondary outcomes will include the onset time of motor and sensory blockade, postoperative pain scores, analgesic requirements over 24 hours and the incidence of adverse effects. The study selection, data extraction and quality assessment will be performed by two independent reviewers. Data processing and analysis will be performed by RevMan 5.4. The quality of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: Ethical approval is not applicable. The results of this study will be submitted to peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42023406362.

Financial burden of postoperative complications following oesophagectomy: a scoping review protocol.

INTRODUCTION: The rapid rise in the incidence of oesophageal adenocarcinoma has resulted in an increasing number of patients undergoing oesophagectomy. Although novel surgical techniques are enhancing surgical outcomes, postoperative complications remain pervasive. Despite this, there are limited reviews mapping the cost of postoperative complications following oesophagectomy, and none has compared cost differences between patient groups. Such information would be invaluable in appreciating the financial burden on the healthcare system and serving to guide hospital financing decisions. This scoping review protocol outlines an approach to reviewing the literature to precipitate and inform discussions surrounding financing oesophagectomy procedures as well as funding requirements for upper gastrointestinal surgical units. METHODS AND ANALYSIS: Adhering to the pertinent components of the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols guidelines, a systematic exploration will be conducted across electronic databases, including MEDLINE, EMBASE, the Cochrane Library and Econolit, with further reference tracking of eligible studies. This review will encompass studies related to the costs associated with complications following oesophagectomy. All studies published prior to 31 October 2023 are eligible for inclusion. The process of screening and extracting data will be undertaken by two independent reviewers. Subsequently, the amassed data will be pooled and subjected to comprehensive analysis and presented descriptively, using both a mixed methods and a narrative approach. ETHICS AND DISSEMINATION: Ethics approval was not required. The results will be communicated through established professional networks, conference presentations and publication in peer-reviewed journals.