BACKGROUND: 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.
BACKGROUND: 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.

BACKGROUND: 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: 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.
BACKGROUND: This review does not require ethics approval. Our dissemination strategy includes peer review publication, conference presentation, co-constructed guidelines with stakeholders and policymakers.
BACKGROUND: This review is registered on OSF.

BACKGROUND: 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: 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.
BACKGROUND: 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.
BACKGROUND: Clinical Trials.gov NCT05281627.

OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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%.
UNASSIGNED: 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.
BACKGROUND: NCT05199025.

BACKGROUND: 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: 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.
BACKGROUND: 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.
BACKGROUND: NCT04803747.

BACKGROUND: 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.
CONCLUSIONS: 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.

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: 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.
BACKGROUND: 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.
BACKGROUND: NCT05276596.

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.
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.
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.
CRD42023408098.

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.
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.
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.
V.3.0, 31 August 2023.
ChiCTR2200057405.

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.
Prospective observational cohort study.
12 National Health Service centres in England.
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.
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.
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).
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.
NCT02841527 and ISRCTN00786323.