Explore the vast range of titles available.

Background Improving the quality and safety of perioperative care is a global priority. The Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial was a stepped-wedge cluster randomised trial of a quality improvement (QI) programme to improve 90-day survival for patients undergoing emergency abdominal surgery in 93 hospitals in the UK National Health Service. Methods The aim of this process evaluation is to describe how the EPOCH intervention was planned, delivered and received, at both cluster and local hospital levels. The QI programme comprised of two interventions: a care pathway and a QI intervention to aid pathway implementation, focussed on stakeholder engagement, QI teamwork, data analysis and feedback and applying the model for improvement. Face-to-face training and online resources were provided to support senior clinicians in each hospital (QI leads) to lead improvement. For this evaluation, we collated programme activity data, administered an exit questionnaire to QI leads and collected ethnographic data in six hospitals. Qualitative data were analysed with thematic or comparative analysis; quantitative data were analysed using descriptive statistics. Results The EPOCH trial did not demonstrate any improvement in survival or length of hospital stay. Whilst the QI programme was delivered as planned at the cluster level, self-assessed intervention fidelity at the hospital level was variable. Seventy-seven of 93 hospitals responded to the exit questionnaire (60 from a single QI lead response on behalf of the team); 33 respondents described following the QI intervention closely (35%) and there were only 11 of 37 care pathway processes that > 50% of respondents reported attempting to improve. Analysis of qualitative data suggests QI leads were often attempting to deliver the intervention in challenging contexts: the social aspects of change such as engaging colleagues were identified as important but often difficult and clinicians frequently attempted to lead change with limited time or organisational resources. Conclusions Significant organisational challenges faced by QI leads shaped their choice of pathway components to focus on and implementation approaches taken. Adaptation causing loss of intervention fidelity was therefore due to rational choices made by those implementing change within constrained contexts. Future large-scale QI programmes will need to focus on dedicating local time and resources to improvement as well as on training to develop QI capabilities. EPOCH trial registration ISRCTN80682973 https://doi.org/10.1186/ISRCTN80682973 Registered 27 February 2014 and Lancet protocol 13PRT/7655.

Background Damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy System, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker’s vacuum pack. Methods/Design The Intra-peritoneal Vacuum Trial will be a single-center, randomized controlled trial. Adults will be intraoperatively allocated to TAC with either the ABThera or Barker’s vacuum pack after the decision has been made by the attending surgeon to perform a damage control laparotomy. The study will use variable block size randomization. On study days 1, 2, 3, 7, and 28, blood will be collected. Whenever possible, peritoneal fluid will also be collected at these time points from the patient’s abdomen or TAC device. Luminex technology will be used to quantify the concentrations of 65 mediators relevant to the inflammatory response in peritoneal fluid and plasma. The primary endpoint is the difference in the plasma concentration of the pro-inflammatory cytokine IL-6 at 24 and 48 h after TAC dressing application. Secondary endpoints include the differential effects of these dressings on the systemic concentration of other pro-inflammatory cytokines, collective peritoneal and systemic inflammatory mediator profiles, postoperative fluid balance, intra-abdominal pressure, and several patient-important outcomes, including organ dysfunction measures and mortality. Discussion Results from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker’s vacuum pack. Trial registration ClinicalTrials.gov identifier http://www.clicaltrials.gov/ct2/show/NCT01355094

Background Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients. Its application in high-risk abdominal surgery is, however, hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring. Arterial waveform analysis provides an easy, minimally invasive alternative to conventional monitoring techniques, and could be valuable in early goal-directed strategies. We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications, quality of life and healthcare costs after high-risk abdominal surgery. Methods/Design In this multicenter, randomized, controlled superiority trial, 542 patients scheduled for elective, high-risk abdominal surgery will be included. Patients are allocated to standard care (control group) or early goal-directed therapy (intervention group) using a randomization procedure stratified by center and type of surgery. In the control group, standard perioperative hemodynamic monitoring is applied. In the intervention group, early goal-directed therapy is added to standard care, based on continuous monitoring of cardiac output with arterial waveform analysis. A treatment algorithm is used as guidance for fluid and inotropic therapy to maintain cardiac output above a preset, age-dependent target value. The primary outcome measure is a combined endpoint of major complications in the first 30 days after the operation, including mortality. Secondary endpoints are length of stay in the hospital, length of stay in the intensive care or post-anesthesia care unit, the number of minor complications, quality of life, cost-effectiveness and one-year mortality and morbidity. Discussion Before the start of the study, hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small, single-center studies, including minor complications as primary endpoint. Moreover, these studies did not include quality of life, healthcare costs, and long-term outcome in their analysis. As a result, the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown, which gave rise to the present trial. Patient inclusion started in May 2012 and is expected to end in 2016. Trial registration This trial was registered in the Dutch Trial Register (registration number NTR3380 ) on 3 April 2012.

Background Inappropriate fluid therapy during surgery is associated with significant morbidity and mortality. Few studies have examined the effects of particular types of fluids (crystalloid or colloid solutions) in surgical patients, especially with the goal of hemodynamic optimization. Isotonic saline is the most commonly used fluid worldwide but may be associated with potential nephrotoxicity. Hydroxyethyl starch (HES) solutions are widely used in surgical patients as a component of goal-directed fluid optimization strategies, but several large multicenter studies have suggested increased rates of acute kidney injury and adverse events with the use of HES in ICU patients. Despite what may be inferred from physiological studies, the benefit and harm of 0.9 % saline and HES during hemodynamic therapy have not been clearly established in surgical patients. Methods/Design The FLASH trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 826 patients with moderate-to-high risk of postoperative complications to receive 6 % HES 130/0.4 or 0.9 % saline during individualized goal-directed fluid optimization. The primary outcome measure is a composite of death or major postoperative complications within 14 days following surgery. The sample size will allow the detection of a 10 % absolute between-group difference in the primary outcome measure with a type 1 error rate of 5 % and power of 95 %, assuming a 5 % mortality rate and 20 % morbidity (thus 25 % for the composite endpoint). Discussion The FLASH trial may provide important data on the efficacy and safety of commonly used fluid solutions and could have a significant impact on future treatment of surgical patients. Trial registration ClinicalTrials.gov Identifier: NCT02502773 . Registered 16 June 2015.

Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

Traumatic intra-abdominal hemorrhage contributes to mortality in patients with trauma. However, initiating an emergent laparotomy in the operating room (OR) as a standard treatment can sometimes be time-consuming. To overcome this issue, laparotomy is performed in the emergency room (ER) in some institutions. This systematic review evaluates the efficacy of performing ER laparotomy. Comprehensive searches were conducted in MEDLINE PubMed, EMBASE, and Cochrane databases, up to August 9, 2024. The risk of bias in observational studies was assessed using the ROBINS-I tool. The primary outcome was mortality following ER laparotomy, and the secondary outcome was time from admission to first laparotomy. The review included 10 studies, all of which were observational. A meta-analysis was not performed due to substantial heterogeneity and insufficient data. Mortality rates after ER laparotomy ranged from 23 to 100%. Mortality rates were 23.0–66.7% in the conventional ER group, while they were 0–30% in the OR group. In the hybrid ER group, the 28-day mortality rates were 12.7–15%, compared to 21.7–22% in the conventional group. The time from admission to the first laparotomy was 17–43 min (median) in the conventional ER group, compared to 40–111 min (median) in the OR laparotomy group. In the hybrid ER setting, the time from admission to intervention, including laparotomy, was 35–48 min (median), whereas it was 72–101 min (median) in the conventional group. A high and unclear risk of bias due to confounding was noted across the studies. ER laparotomy may provide rapid bleeding control. However, due to the limited number of studies and significant heterogeneity among the studies reviewed, the true effect size of ER laparotomy in conventional and hybrid ER settings remains unclear.

Damage control laparotomy (DCL) is performed for physiologically deranged patients. Recent studies suggest overutilization of DCL, which may be associated with potentially iatrogenic complications. We conducted a retrospective study of trauma patients over a 2-year period that underwent an emergent laparotomy and received preoperative blood products. The group was divided into definitive laparotomy and DCL. A total of 237 received were included: 78 in definitive laparotomy group, 144 in the DCL group, and 15 who died in the operating room. The DCL group was more severely injured and required more transfusions. After propensity score matching, DCL was associated with an 18% increase in hospital mortality, a 13% increase in ileus, and a 7% increase in enteric suture line failure, an 11% increase in fascial dehiscence, and a 19% increase in superficial surgical site infection. The potential overuse of DCL unnecessarily exposes patients to increased morbidity and mortality. •In bleeding patients, damage control laparotomy (DCL) can be life-saving.•In this cohort of bleeding patients, DCL appears overused.•DCL is associated with an increase in multiple complications.•DCL is associated with an 18% increase in mortality.•Overutilization of DCL exposes patients to potentially iatrogenic complications.

Background Frailty and sarcopenia have been independently shown to predict mortality in emergency laparotomy (EmLap), and both can be indicative of poor physical status. We aim to assess the prevalence of frailty, sarcopenia, and physical status in EmLap and explore the relationship between these factors and 30-day, 90-day and 1-year mortality. Methods Retrospective analysis was performed on prospectively maintained Emergency Laparotomy and Laparoscopic Scottish Audit (ELLSA) database (2017–2019) which included patients ≥ 18 years who underwent EmLap. Clinical frailty scale (CFS) was used to classify frailty (score ≥ 4 as frail). Sarcopenia was assessed using total psoas index (TPI). Poor physical status (PPS) was defined by American Society of Anaesthesiologists physical status classification (ASA) ≥ 4. Binary logistic regression and fisher’s exact tests were used for statistical analysis. Results 215 patients were included in the study, with 57.2% female and median age of 64 years. Frailty was present in 17.2%, sarcopenia in 25.1% and 14.4% had PPS; 3.3% had all three factors. Frail patients had significantly higher risk for 30-day ( p  = 0.003), 90-day ( p  = 0.006) and 1-year mortality ( p  = 0.032). Patients with poor physical status also showed significantly higher mortality at 30-day ( p  < 0.001), 90-day ( p  < 0.001) and 1-year ( p  = 0.001). Sarcopenic patients did not show significant differences in mortality risks up to 1 year. Patients with all three factors had significantly higher 30-day ( p  = 0.003), 90-day ( p  = 0.046) and 1-year mortality ( p  = 0.108) compared to patients who had none of the factors. Conclusions Frailty, sarcopenia, and PPS are prevalent in EmLap. Frailty and PPS were independently associated with short and long-term mortality, but not sarcopenia. While overlap exists between three factors, more research is required to understand the complex interplay.

Background The high prevalence of caesarean section (CS) is a global concern. Relaparotomy is needed when conservative managements are not effective in CS complications. This study aimed to systematically review and meta-analyze the mortality rate and risk factors of relaparotomy after CS. Methods Based on a pre-registered protocol, we searched 11 databases. The MOOSE guideline was followed, and the reporting was in accordance with the PRISMA statement. A Freeman-Tukey double arcsine transformation was used to transform the raw data, and a random-effects meta-analytic model was applied. The quality of the evidence was evaluated by Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results The qualities of the pooled results were assessed to be “very low” based on the inclusion of observational studies. A total of 40 studies were retrieved. The mortality rate in patients after relaparotomy was 7.24% (95%CI 4.10-11.03%). Significant gap existed between high-resources and low-resources countries. In developed areas this rate was 0.56% and in places of low resources this rate was 16.90%. Higher CS rate correlated with higher mortality. Over 70% of the relaparotomies followed emergent CS. Risk factors associated with relaparotomy included higher maternal age, CS performed in the second stage of labor, twin pregnancy, preterm birth (OR 2.72, 95%CI 1.87–3.95) and preeclampsia (OR 3.24, 95%CI 1.47–7.14). Conclusion Our findings demonstrated the high mortality rate in patients who had relaparotomy after CS. Interpretation of the results should be with caution due to GRADE evidence level. During a time when there is an imbalance in medical resources in different countries, interventions to reduce CS rate, good prenatal care and intensified post-operative management are important. Trial registration PROSPEROCRD42021265325.

Background The United Kingdom population is ageing. Half of patients requiring an emergency laparotomy are aged over 70, 20 % die within 30 days, and less than half receive good care. Frailty and delay in management are associated with poor surgical outcomes. P-POSSUM risk scoring is widely accepted, but its validity in patients aged over 70 undergoing emergency laparotomy is unclear. Aims: To assess if P-POSSUM risk stratification reliably predicts inpatient mortality in this group and establish whether those who died within 30 days received delayed care. Methods Observational study of consecutive patients aged 70 and over fulfilling the National Emergency Laparotomy Audit criteria from a tertiary hospital. The predictive value of pre-operative P-POSSUM, ASA, lactate and other routine variables was assessed. Surgical review, decision to operate, consultant surgical review, antibiotic prescription, laparotomy and discharge or death time points were assessed by 30-day survival. Results One hundred and ninety-three patients were included. This represented 46.28 % of those undergoing an emergency laparotomy in our centre. Pre-operative P-POSSUM scoring, ASA grade and lactate were moderate predictors of mortality (AUC 0.784 and 0.771, respectively, lactate AUC 0.705, all p  ≤ 0.001). No correlation existed between pre-operative P-POSSUM and days to death ( p  = 0.209), nor were there delays in key management timings in those who died in 30 days. Conclusions P-POSSUM scoring may predict inpatient mortality with moderate discrimination. Addition of frailty scoring in this high-risk group might better identify those with a high risk of mortality after emergency laparotomy and would be a fertile area for further research.