OBJECTIVES:Surgical safety checklists (SSCs) are widely used tools aimed at reducing postoperative complications and mortality. While compliance is generally high, adherence to individual checklist sections and completeness can vary. This study aimed to assess compliance and completion rates of a locally modified 6-section SSC. METHODS:We conducted a retrospective analysis of all inpatient and outpatient surgeries performed at a secondary-level hospital in northeastern Switzerland between January 1 and March 31, 2023. The presence and completeness of the scanned SSCs in the electronic medical records were evaluated. Multivariable logistic regression models were used to identify factors associated with missing or incomplete SSCs. RESULTS:A total of 2376 surgeries were analyzed. Overall, SSC compliance was high, with a scanned checklist present in 98% (n=2329) of cases; however, only 73% (n=1734) were fully completed. Missing or incomplete SSCs were more frequent in emergency procedures, outpatient surgeries, cases with local anesthesia, procedures performed on Fridays, certain surgical departments, lower-volume operating rooms, and earlier positions in the surgical schedule. Multivariable analysis confirmed that emergency procedures and the use of local anesthesia were independently associated with lower odds of full SSC completion. No clear associations were found with age, sex, health insurance type, or whether procedures were performed during regular operating hours. The "Sign-In" and "Team Time-Out" sections had the highest completion rates, whereas "Patient Ready for Operating Room" and "Sign-Out" were most frequently omitted. CONCLUSIONS:This study demonstrated a high overall rate of SSC compliance, though variation among checklist sections was observed. Specific contexts-particularly emergency and outpatient settings-were associated with reduced completeness, indicating opportunities for targeted quality improvement.
BACKGROUND:Length of hospital stay (LOS) is a commonly reported postoperative outcome measure in pancreatic surgery. However, LOS may be influenced by various factors, including healthcare systems, cultural traditions, and readmission rate. This systematic review and meta-analysis investigated LOS in pancreatic surgery. METHODS:A meta-analysis was conducted to identify all randomized clinical trials (RCTs) of pancreatic surgery reporting LOS. Analyses were conducted using a random-effects model with mean differences as the effect estimator for the continuous outcome LOS. RESULTS:In all, 186 RCTs published between 1994 and 2025, comprising 28 381 patients, were included. The mean LOS differed significantly by type of resection (P = 0.003) and by country (P < 0.001). Country remained a statistically significant factor after adjusting for readmission rate, year of study, and type of resection. The shortest LOS was observed in the USA, with a pooled value of 11 days (95% confidence interval (c.i.) 9.93 to 12.32) and the longest was seen in Japan, with a pooled value of 28 days (95% c.i. 25.60 to 31.67). Subgroup analysis of studies comparing minimally invasive and open surgery showed a mean LOS difference of 2 days (95% c.i. -2.79 to -0.85; prediction interval -7.70 to 4.06). However, this effect varied across countries, with mean LOS differences ranging from 1 to 6 days. CONCLUSION:LOS after pancreatic surgery exhibited substantial statistical heterogeneity based on country, the type of operation, and access. This highlights the importance of considering contextual factors when evaluating and comparing LOS as an outcome measure in pancreatic surgery.
Appendicitis is one of the most common diseases of the gastrointestinal tract with a lifetime incidence of 7 to 9
BACKGROUND:Predicting postoperative body mass index (BMI) trajectories and long-term type 2 diabetes (T2D) remission after bariatric surgery remains challenging. Existing models often rely on baseline variables only and fail to incorporate dynamic postoperative changes. This study aimed to develop and validate a multicentre machine-learning framework that predicts individualized BMI trajectories and T2D remission using routinely available preoperative data and time-dependent weight evolution. METHODS:This multicentre retrospective cohort study included adult patients who underwent Roux-en-Y gastric bypass or sleeve gastrectomy across 11 European centres (2012-2023). Variables with > 30% missing data were excluded; remaining missing values were imputed iteratively. A two-stage approach was used: a regression model predicting postoperative BMI at 3-60 months using an autoregressive design; and a classification model predicting T2D remission using baseline features and predicted BMI trajectories. Internal performance was evaluated with ten-fold and leave-one-clinic-out cross-validation; external validation used an independent cohort from Linköping, Sweden. RESULTS:Of the 11 457 patients initially identified, 9652 patients with complete baseline and follow-up information were used for the analysis. The best BMI model (HistGradientBoosting) achieved a root mean square error (RMSE) of 1.11 kg/m2 (95% confidence interval 1.07 to 1.14) and a mean absolute error (MAE) of 0.62 kg/m2 across clinics; external testing showed an RMSE of 1.12 kg/m2 (95% confidence interval 1.11 to 1.12) and an MAE of 0.63 kg/m2. The T2D remission classifier (XGBoost) obtained a Macro F1 score of 0.88 (precision 0.87, recall 0.88), with an external F1 score of 0.89. Incorporating predicted BMI trajectories improved discrimination compared with baseline-only models (C-index 0.95 versus 0.93). CONCLUSION:A two-stage machine-learning framework has high predictive performance for postoperative BMI and T2D remission up to 5 years after bariatric surgery. Dynamic incorporation of predicted weight trajectories enhances metabolic risk prediction and supports individualized counselling and postoperative management.
There are numerous techniques for right-sided colonic resections with primary ileocolic anastomosis. This study investigated the impact of various access routes and different anastomotic techniques on short- and long-term outcomes. A systematic literature search was performed in CENTRAL (Cochrane Central Register of Controlled Trials), PubMed, and Web of Science (last search December 15, 2025). All randomized clinical trials (RCTs) investigating surgical techniques for right-sided colonic resections (i.e., ileocecal resection, right hemicolectomy) were reviewed. A meta-analysis (random-effects model) was conducted. Risk of bias (Cochrane 2.0) and certainty of evidence (GRADE) were assessed. Thirty-three RCTs with 3787 patients were included. Twelve RCTs (1552 patients) compared open with laparoscopic surgery. Open surgery may result in shorter operation time (MD − 38.75 min, 95
Introduction Surgical site infections (SSI) impose a substantial clinical and economic burden on healthcare systems, accounting for approximately 15% of nosocomial infections. While intraoperative lavage is predominantly performed with isotonic solutions, its efficacy in preventing SSI remains unproven. Hypochlorous acid (HOCl) has emerged as a promising antimicrobial agent due to its potent microbicidal properties and high biocompatibility. The primary objective of this study is to evaluate whether the systematic introduction of a standardised intraoperative lavage with HOCl reduces the incidence of SSI in patients undergoing elective visceral surgery compared with conventional irrigation with isotonic saline. It is hypothesised that the implementation of HOCl-based lavage will lead to a significant reduction in the composite rate of superficial, deep and organ/space SSIs during the immediate postoperative hospitalisation period.Methods This is a single-centre, prospective, sequential, quasi-experimental trial conducted at Heidelberg University Hospital. A prospective cohort of approximately 500 adult patients undergoing elective visceral surgery with HOCl-based lavage (Granudacyn) will be compared with a sequential retrospective control cohort of 500 patients treated with isotonic solution. The primary outcome is the incidence of SSI (superficial, deep or organ/space) according to Centres for Disease Control and Prevention criteria, assessed until hospital discharge or postoperative day 10 (±2 days). Secondary outcomes include length of stay in the intensive care unit and hospital, duration of antibiotic therapy and the Comprehensive Complication Index (CCI).Ethics and dissemination The study protocol has been approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-522/2025). Findings will be disseminated through peer-reviewed publications and presentations at international surgical congresses to inform clinical practice and future SSI prevention guidelines.Trial registration number DRKS00038635
Introduction Surgical site infections (SSI) impose a substantial clinical and economic burden on healthcare systems, accounting for approximately 15% of nosocomial infections. While intraoperative lavage is predominantly performed with isotonic solutions, its efficacy in preventing SSI remains unproven. Hypochlorous acid (HOCl) has emerged as a promising antimicrobial agent due to its potent microbicidal properties and high biocompatibility. The primary objective of this study is to evaluate whether the systematic introduction of a standardised intraoperative lavage with HOCl reduces the incidence of SSI in patients undergoing elective visceral surgery compared with conventional irrigation with isotonic saline. It is hypothesised that the implementation of HOCl-based lavage will lead to a significant reduction in the composite rate of superficial, deep and organ/space SSIs during the immediate postoperative hospitalisation period.Methods This is a single-centre, prospective, sequential, quasi-experimental trial conducted at Heidelberg University Hospital. A prospective cohort of approximately 500 adult patients undergoing elective visceral surgery with HOCl-based lavage (Granudacyn) will be compared with a sequential retrospective control cohort of 500 patients treated with isotonic solution. The primary outcome is the incidence of SSI (superficial, deep or organ/space) according to Centres for Disease Control and Prevention criteria, assessed until hospital discharge or postoperative day 10 (+/- 2 days). Secondary outcomes include length of stay in the intensive care unit and hospital, duration of antibiotic therapy and the Comprehensive Complication Index (CCI).Ethics and dissemination The study protocol has been approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-522/2025). Findings will be disseminated through peer-reviewed publications and presentations at international surgical congresses to inform clinical practice and future SSI prevention guidelines.Trial registration number DRKS00038635
ABSTRACT Background and Aims Myocardial injury after non‐cardiac surgery (MINS) is a significant postoperative complication. In 2022, the European Society of Cardiology (ESC) updated its guidelines, recommending perioperative troponin monitoring for a broader surgical population. This study aimed to assess the implications of implementing these guidelines in a secondary Swiss hospital. Methods Patients meeting ESC guideline criteria for troponin testing were identified, along with those undergoing surgeries deemed similar in risk and complexity. We retrospectively analyzed all in‐patient non‐cardiac surgeries performed in 2023 (n = 6413). Demographic data, cardiac risk factors, new cardiac diagnoses, and mortality within 3 months post‐surgery were assessed. The primary outcome was the demand for postoperative troponin testing when applying the 2022 ESC guidelines. The secondary outcome was to detect new cardiac diagnoses among patients meeting these criteria. Results Of the 6413 in‐patient surgeries, 1306 (20%) met the guideline's or study‐defined criteria for intermediate‐risk, high‐risk, or procedures similar regarding risk and complexity. After excluding ineligible patients, we analyzed data from 1231 patients, and found 1089 patients (88% of included patients; 17% of all patients) who would have required testing. Within 3 months postoperatively, we identified 72 patients (6%) who developed new cardiac conditions and 54 patients (4%) died. Surgeries outside regular hours comprised 17% of cases. Conclusion Substantial postoperative troponin testing would be required to comply with the 2022 ESC guidelines, necessitating expanded organizational capacity and resources. While the value of early detection and prevention of MINS is clear, implementation in routine clinical practice may be challenging.
Introduction Percutaneous drainage is the standard of care for intra-abdominal abscesses. Additional saline irrigation provides mechanical cleansing but lacks antimicrobial activity. Hypochlorous acid (HOCl), an endogenous antiseptic with broad-spectrum microbicidal activity and high tissue compatibility, is a promising alternative for intracavitary infection control. This study evaluates whether HOCl irrigation shortens the indwelling time of percutaneous irrigation drains and systemic antibiotic duration compared with saline irrigation in patients with intra-abdominal abscesses.Methods and analysis Following an institutional change in routine practice on 1 December 2025, this single-centre, controlled, ambispective cohort study at the Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, compares a prospectively followed cohort treated with continuous HOCl-containing irrigation (Granudacyn) with a non-concurrent, retrospectively assembled saline cohort from the preceding period. Both cohorts include drains managed with continuous high-volume irrigation (at least 1 L per 24 h for a minimum of 3 consecutive days). The primary endpoints are the indwelling time of the index irrigation drain (placement to removal) and the duration of systemic antibiotic therapy. Secondary endpoints include hospital and intensive care unit stay, reinterventions, complication severity (Clavien–Dindo), time to fistula closure and infection-related parameters. Confounding is addressed using propensity-score methods, and time-to-event endpoints are analysed accounting for competing events.Ethics and dissemination The study has received ethical approval from the Ethics Committee of Heidelberg University’s Medical Faculty (S-520/2025). As pseudonymised routine clinical data are used without additional patient contact or deviation from standard care, individual informed consent is waived in accordance with the national regulations and General Data Protection Regulation. Study findings will be disseminated through peer-reviewed publications.Trial registration number DRKS00038653.
Introduction Cholecystolithiasis is a common condition and most cases are asymptomatic. In symptomatic cases, gallstone disease results in hospitalisation and significant healthcare costs. Laparoscopic cholecystectomy is the standard treatment and is traditionally performed in an inpatient setting. Recent studies indicate that outpatient laparoscopic cholecystectomy may offer comparable safety and effectiveness yet the feasibility and cost-effectiveness are not conclusively defined. Methods and analysis This randomised-controlled, open-label feasibility trial will be conducted at two surgical centres in Thurgau, Switzerland. A total of 50 participants will be randomly assigned (1:1) to receive either outpatient or inpatient laparoscopic cholecystectomy. The primary endpoints include feasibility, safety and cost-effectiveness. Secondary endpoints assess mortality, postoperative complications, reinterventions and readmission rates, emergency department visits, pain, length of hospital stay, time to return to work and additional healthcare resource utilisation. The total follow-up will be 14 days. Ethics and dissemination The study has been approved by the local ethics committee and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be disseminated through peer reviewed publications and conference presentations. Trial registration number DRKS00039001.
Abstract Background Systematic reviews require reviewers to decide on the eligibility of large numbers of articles derived from database searches. To accelerate review conduct while continuously more literature gets published, past studies proposed automating the title/abstract-screening step by either supervised machine learning or large language models. Because prior studies mainly compared results within the same model family, we directly compared common TF-IDF-based supervised baselines and a zero-shot, criteria-prompted, and open-weight large language model on the same data to discuss whether, and in which scenarios, they are feasible for review screening automation. Methods We predicted the eligibility of labeled articles by four supervised machine learning models (Naïve Bayes, support vector machine, random forest, logistic regression) and one large language model (Llama-3.1—8B-Instruct). Articles were labeled with eligibility as decided by human reviewers in six systematic reviews. We evaluated the performance by binary confusion matrices and calculated recall, specificity, precision, F1-score, and accuracy over a thousand bootstrap samples each. We compared these results to a reported performance of 0.86 (recall) and 0.79 (specificity) in single human reviewers. Results Model performance varies greatly between the data sets. Except for Naïve Bayes, recall and specificity are closer aligned in the supervised machine learning models compared to llama. Averaged across all datasets, llama matches human recall and the Naïve Bayes classifier exceeds it, while both fall behind human specificity. Conversely, logistic regression, random forest and support vector machine fall behind human recall while all three exceed human specificity. Conclusions Both supervised machine learning and large language models achieve recalls close to or above those of human reviewers. The supervised machine learning models achieve a higher harmonic mean of recall and specificity, while the llama model is more sensitive. Considering the reliance on training data and the all-or-nothing automation with supervised machine learning, this study’s results warrant their use in the extension of pre-existing, non-critical, systematic reviews. Contrarily, as large language models decide on articles individually and as they provide comprehensive, discussable, reasoning they may be used in tandem with human reviewers while the performance of ensembles of large language models is yet to be analyzed.
Background:With the recent publication of the first randomized controlled trials (RCTs) comparing robotic partial pancreatoduodenectomy (RPD) versus open partial pancreaticoduodenectomy (OPD) now providing high-level evidence, this study aims to analyze the short-term outcomes of RPD versus OPD to answer the ongoing clinical debate regarding the advantages and limitations of RPD, particularly in terms of perioperative safety. Methods:We searched Medline, Web of Science, and CENTRAL accessed last on 26th of November 2025 for prospective studies. The main outcome was 90-day mortality; secondary outcomes included complications, and short-term oncological outcomes (R0 resection rate), among others. A random-effects model was employed. Risk of bias was assessed using the Cochrane risk-of-bias-tool (RoB 2) for randomized controlled trials (RCTs), and the ROBINS-I-tool for comparative cohort trials (CCTs). The certainty of evidence was graded according to GRADE. (PROSPERO registration ID: CRD42024523577). Findings:Out of a total of 7388 screened studies, 358 studies underwent full-text screening leading to inclusion of 7 studies (3 RCTs and 4 CCTs). No significant difference was observed between RPD and OPD for 90-day mortality [OR (95% CI) 1.07 (0.04, 29.40)], clinically relevant complications including postoperative pancreatic fistula (POPF), or reoperation rates [OR (95% CI) 1.10 (0.47, 2.59)]. Lymph node yield, R0 resection rate, operative time and length of hospital stay were also not significantly different. However, readmission rates favored OPD [OR (95% CI) 1.22 (1.15, 1.28)], while there was a lower amount of intraoperative blood loss in RPD [SMD (95% CI) -0.98 (-1.65, -0.32)]. Interpretation:In this systematic review and meta-analysis, mortality following RPD was comparable to OPD. RPD has demonstrated similar rates for major complications and short-term oncological outcomes and can thus be equally recommended as OPD but this recommendation is limited to experienced, high-volume centers. Funding:This systematic review and meta-analysis was investigator-initiated and did not receive additional funding.
Introduction Surgical site infections (SSIs) impose a significant clinical and economic burden on the healthcare systems. To date, traditional preventive strategies have frequently failed to demonstrate definitive efficacy. Hypochlorous acid (HOCl) has emerged as a compelling antimicrobial alternative, characterised by potent microbicidal properties and excellent biocompatibility. Hypoclates:Peritonitis investigates the clinical impact of an HOCl-based lavage strategy in patients undergoing surgical treatment for secondary peritonitis. The trial evaluates the primary endpoint of postoperative SSI incidence up to day 10 (±2 days), hypothesising that the antimicrobial and biocompatible properties of HOCl significantly lower infection rates compared with standard isotonic lavage.Methods Using a sequential, quasi-experimental design, this mono-centric study assesses the clinical impact of adopting an intensified, multi-day HOCl-lavage protocol (Granudacyn) for patients with secondary peritonitis. We will compare a prospective intervention group (n≈100) against a preceding cohort of equal size that received standard isotonic irrigation. The primary endpoint is defined as the frequency of SSIs—inclusive of superficial, deep and organ/space infections according to Centers for Disease Control and Prevention criteria—monitored through hospital discharge or up to postoperative day 10 (±2 days). Secondary evaluative measures include the length of intensive care unit and total hospital stay, the duration of postoperative antibiotic therapy and the cumulative morbidity burden as calculated by the Comprehensive Complication Index.Ethics and dissemination Ethical clearance for this trial was provided by the Institutional Review Board of the Medical Faculty of Heidelberg University (S-523/2025). To facilitate knowledge transfer and evidence-based practice, the study results will be presented at international scientific meetings and published in peer-reviewed journals, thereby contributing to the refinement of SSI prevention protocols in emergency visceral surgery.Trial registration number German Clinical Trials Register (DRKS), DRKS00038630.
Introduction Outcome after surgery depends on both patient-related as well as procedure-related risks. Complications after surgery are a significant burden to patients and to the health system. A vast amount of often unstructured data from different sources are generated during surgery, which contain valuable information associated with outcome. Advances in computer hardware and machine learning now increasingly facilitate the development of prediction models in standardised, parametric, information-rich areas such as the perioperative setting. For the development and validation of risk scores and prediction models, high-fidelity data sources are required to arrive at meaningful and reliable predictions. However, data quality standards in retrospective studies are rarely met. Therefore, the prospective Heidelberg Perioperative Deep Data Registry and Biomaterial Bank (HeiPoDD - Registry and Bio Bank) was started to implement a clinical data base and a corresponding biobank merging the entirety of available clinical records.Methods and analysis The HeiPoDD - Registry and Bio Bank is a study-driven, prospective, single-centre observational registry data base and biomaterial bank. It contains data and material from eligible patients who give informed consent and undergo elective non-cardiac high-risk surgery at the surgical centre of the Heidelberg University Hospital. The screening for eligibility started in January 2022, with no maximum sample size specified in advance. Routine data are recorded and stored during hospital stay and potential readmissions within 90 days after index surgery. The data are merged with the potentially available genome, proteome, flow cytometry, and bio signal data. Endpoints are obtained from routine observations, stored data in the hospital information system and follow-up visits. Further, data and biological specimens from separate perioperative studies with the patients’ consent can be transferred into the HeiPoDD - Registry and Bio Bank as well. This large-scale data collection will allow the calculation of endpoint-specific prediction models using logistic regression models as well as machine learning models. The first 1040 patients included in the HeiPoDD - Registry and Bio Bank are also included in the HeiPoDD study.Ethics and dissemination The trial protocol and subsequent amendments were approved by the ethics committee of the University of Heidelberg (S-745/2021). Participating patients’ data will be entered only in pseudonymised form. Data and biomaterials will be kept for up to 30 years. The findings will be disseminated in peer-reviewed academic journals.Trial registration number DRKS00025924, registered on 2021-11-12.
Prophylactic intraabdominal drainage following distal pancreatectomy (DP) has been a longstanding practice to mitigate postoperative complications, particularly postoperative pancreatic fistulas (POPF). Recent studies challenge the necessity of routine drainage, suggesting potential benefits in omitting drains. The aim of this trial was to evaluate postoperative complications after DP with or without prophylactic drain placement. The PANDRA II trial was a randomized controlled non-inferiority study conducted at a university hospital between 2017 and 2023, comparing outcomes between patients undergoing open or minimally-invasive DP with and without prophylactic abdominal drainage. Primary endpoint was postoperative morbidity assessed by the Comprehensive Complication Index (CCI). A total of 246 patients were included in the intention-to-treat analysis (125 with drainage, 121 without drainage). The no-drain group demonstrated non-inferiority to the drain group in terms of CCI (13.90 ± 16.51 vs. 19.43 ± 16.92, p<0.001). Moreover, the no-drain group had lower overall complication rates (50.41% vs. 78.40%, p<0.001). Specific complications such as POPF (14.88% vs. 20.8%, p=0.226) and post-pancreatectomy hemorrhage (4.96% vs. 4.80%, p>0.999) did not differ significantly between groups. The PANDRA II trial adds to mounting evidence suggesting that routine abdominal drainage may not be necessary following DP. Omitting drains was associated with favorable outcomes in terms of postoperative morbidity, without increasing severe complications requiring intervention. Selective use of drains based on patient risk factors and surgeon expertise is crucial, emphasizing individualized care in pancreatic surgery.
Background:Recently, surgical data recorders that are comparable to flight data recorders, also known as black boxes in the aviation industry, have been developed to improve patient safety and performance in surgery. These devices allow for unique insights in the operating room by providing new data capture capabilities. No systematic review has been carried out to evaluate the areas of application of surgical data recorders to date. Objective:This systematic review and single-arm meta-analysis aims to assess the aspects of the operating theater environment for which surgical data recorders are used and to make a preliminary assessment of the quantifiable data that can be collected, compared to traditional collection methods. Methods:This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Medline, Embase, and Web of Science databases were lastly systematically searched for papers that focused on a clinical use case for surgical data recorders on February 10, 2025. In particular, not relevant papers focusing on implementation of surgical data recorders were excluded. Title, abstract, and full-text screening were completed to identify relevant articles. The included studies were analyzed descriptively using data extraction forms. Where possible, quantifiable data was also analyzed. Risk of bias was assessed using the Risk Of Bias In Non-Randomized Studies of Exposure (ROBINS-E) tool. Results:In total, 70 studies were screened, and a total of 17 studies were included. A total of 10 of the 17 studies had a low overall risk of bias; however, confounding, selection bias, small sample sizes, short study periods, and potential Hawthorne effects were the notable limitations. Only 2 studies were assessed to have publication bias. Use cases could be grouped into 4 categories: economic, safety, behavior in the operating room, and technical skill assessment. A single-arm meta-analysis focusing on adverse events and distractions in the operating theater could be conducted, demonstrating accurate reporting of distractions in line with the existing literature. Conclusions:Surgical data recorders provide an unobstructed view of various aspects of the operating theatre. Most published papers present preliminary studies on surgical data recorders, indicating the potential for further, larger-scale studies with enhanced methodological quality.
Multiple studies have shown a decrease in complications after pancreatic surgery through the perioperative use of corticosteroids. This is in part due to their ability to influence the postoperative systemic response. The aim of this systematic review was to investigate the impact of perioperative corticosteroids in major pancreatic resections. A literature search was done in CENTRAL, Medline, and Web of Science. All randomised controlled trials (RCTs) with adult patients undergoing pancreatic surgery and receiving perioperative corticosteroid treatment were included. The outcomes investigated included mortality, complications, postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), postpancreatectomy hemmorrhage (PPH), fluid collection/abscess, and length of hospital stay. Outcomes were analysed as odds ratios (OR) or mean differences (MD) in a random-effects model. Five RCTs were included. Partial pancreatoduodenectomy as well as distal pancreatectomy were evaluated. There was no difference regarding mortality in 3 RCTs (OR 0,65, 95%-CI: 0.17 to 2,45, p= 0.52). However, complications were lower in the corticosteroids group (OR 0.53, 95%-CI: 0.3 to 0.91, p= 0.02). Specifically, there were fewer fluid collections in the corticosteroids group (OR 0.47, 95%-CI: 0.25 to 0.89, p= 0.2). POPF, DGE, and PPH did not differ between the groups. Furthermore, patients treated with corticosteroids had a shorter length of hospital stay (MD -0.87 days, 95%-CI: -5.23 to -2.51, p= 0.01). The perioperative use of corticosteroids in pancreatic surgery appears to reduce overall complications, particularly fluid collections, and is associated with a shorter length of hospital stay. These findings suggest that corticosteroids may provide a benefit in reducing postoperative morbidity, warranting further investigation into their role in optimising outcomes after major pancreatic resections.
OBJECTIVE:To provide a composite endpoint in pancreatic surgery. BACKGROUND:Single endpoints in prospective and randomized studies have become impractical due to their low frequency and the marginal benefit of new interventions. METHODS:Data from prospective studies were used to develop (n=1273) and validate (n=544) a composite endpoint based on postoperative pancreatic fistula, postpancreatectomy hemorrhage, as well as reoperation and reinterventions. All patients had pancreatectomies of different extents. The association of the developed PAncreatic surgery Composite Endpoint (PACE) with prolonged length of hospital stay >75th percentile and mortality was assessed. A single-institution database was used for external validation (n=2666). Sample size calculations were made for single outcomes and the composite endpoint. RESULTS:In the internal validation cohort, the PACE demonstrated an area under the curve of 78.0%, a sensitivity of 90.4%, and a specificity of 67.6% in predicting a prolonged length of hospital stay. In the external cohort, the area under the curve was 76.9%, a sensitivity of 73.8%, and a specificity of 80.1%. The 90-day mortality rate was significantly different for patients with a positive versus a negative PACE both in the development and internal validation cohort (5.1% vs 0.9%; P < 0.001), as well as in the external validation cohort (8.5% vs 1.2%, P < 0.001). The PACE enabled sample size reductions of up to 80.5% compared to single outcomes. CONCLUSIONS:The PACE performed well in predicting prolonged hospital stays and can be used as a standardized and clinically relevant endpoint for future prospective trials enabling lower sample sizes and therefore improved feasibility compared to single outcome parameters.