Study of TOfacitinib for the treatment of chronic PouchITis (STOPit) is a national, investigator-led, multicentre, open-label induction with randomised, double-blind, placebo-controlled maintenance trial to determine the effectiveness of tofacitinib to induce and maintain clinical remission in chronic pouchitis patients. The primary objective of STOPit is to evaluate the clinical response to tofacitinib, compared with placebo, using the validated modified Pouchitis Disease Activity Index score. Secondary objectives include clinical response and remission rates, endoscopic response and mucosal healing rates in induction and maintenance phases; rates of flare and recapturing response in open label extension phase; the effect of tofacitinib on clinical biomarkers and quality of life; and safety of tofacitinib use for treatment of chronic pouchitis. Study period is up to ten months, with five visits and three pouchoscopies. Adults with ulcerative colitis who have undergone total proctocolectomy and ileal pouch-anal anastomosis and have chronic pouchitis are eligible. Participants receive open-label 10 mg two times per day tofacitinib for 8 weeks. Clinical responders at the end of week 8 will be randomised to either tofacitinib or placebo in the maintenance phase. Non-responders will receive extended induction dosing for a further 8 weeks. Persistent non-responders exit the study and responders will proceed to maintenance randomisation. Randomised individuals will be followed for 24 weeks. Patients experiencing a flare of symptoms during the maintenance phase will be eligible to receive open-label tofacitinib. Efficacy and safety data will be evaluated at 12 weeks after termination from the study. Target sample size is 72 patients to be randomised into maintenance to achieve sufficient power. Data analysis is planned to commence in October 2026. Ethics approval was granted (Project ID 66809) and the trial was notified (CTN: CT-2020-CTN-04866-1; ANZCTR: 381128) prior to commencement. The study will be conducted in accordance with National Health and Medical Research Council (NHMRC) guidelines, and findings will be published in a peer-reviewed journal. CTN: CT-2020-CTN-04866-1.
This study aimed to explore the psychosomatic state of patients with functional gastrointestinal disorders (FGIDs), with the hypothesis that depression and anxiety are closely associated with somatic symptoms in patients with FGIDs. Retrospective cross-sectional study. The study was conducted in gastroenterology outpatient clinics. The analysis included 655 patients with FGIDs treated between March 2021 and December 2024. There were no interventions in this observational study. The primary outcome measure was the somatisation subscale score of the Symptom Checklist-90 (SCL-90-SOM). Secondary outcome measures included scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). Heart rate variability (HRV) was also measured. Patients with FGIDs demonstrated relatively high SAS and SDS scores. Multivariable linear regression showed that female gender and higher SAS score were associated with higher SCL-90-SOM scores after adjustment for available covariates. SDS score showed a negative coefficient after adjustment for SAS, which may reflect adjustment-related suppression or symptom-scale overlap rather than a protective effect of depressive symptoms. A statistically significant interaction between SAS and SDS on somatic symptoms was observed using standardised variables (B=0.042, 95% CI 0.018 to 0.067, P interaction<0.001). Among patients with FGIDs in this single-centre outpatient sample, anxiety symptoms were strongly associated with higher somatic symptom burden. Depressive symptoms modified the association between anxiety and somatic symptoms in the interaction model. However, interpretation is limited by the cross-sectional design, possible symptom-scale overlap and residual confounding. These findings support further prospective studies and suggest that assessment of co-occurring anxiety and depressive symptoms may be clinically relevant in FGID care.
To determine whether robotic pancreatoduodenectomy (RPD) is non-inferior to open pancreatoduodenectomy (OPD) in terms of postoperative functional recovery, without compromising safety or oncological quality. Multicentre, single masked, phase 3, non-inferiority randomised controlled trial. Seven tertiary high volume pancreatic centres in China, 15 June 2020 to 28 November 2024. 268 adults with resectable pancreatic or periampullary disease. Participants were randomised to receive standardised RPD (n=142) or OPD (n=126), with enhanced recovery pathways. The primary outcome was time from surgery to postoperative functional recovery, defined as adequate pain control without parenteral analgesia, ≥50% oral intake without intravenous fluids, independent mobilisation, and absence of active intra-abdominal infection. The restricted mean event time (RMET) within 40 days was a summary for time from surgery to postoperative functional recovery. Secondary outcomes included operative metrics, disease related outcomes, length of stay, postoperative morbidity, including complications of Clavien-Dindo grade II or higher (defined as complications requiring drug treatment or more intensive intervention), and hospital admission costs. Overall, 254 of 268 randomly assigned participants (mean age 62 years; 172 (64.2%) men) underwent surgery, completed follow-up, and were included in the modified intention-to-treat population; 14 did not undergo surgery. In the modified intention-to-treat population, the RMET was 12.1 days (95% confidence interval (CI) 11.2 to 13.1) in the RPD group and 16.0 days (14.5 to 17.5) in the OPD group (difference -3.9 days, 95% CI -5.6 to -2.2; P<0.001). Operative time was longer in the RPD group (300 minutes (interquartile range (IQR) 240-360 minutes) versus 270 (210-300) minutes in the OPD group, P<0.001) but postoperative length of stay was shorter in the RPD group (13 (IQR 11-16) days v 16 (13-20) days, P<0.001). Overall postoperative morbidity was 31.1% (41/132) in the RPD group versus 36.1% (44/122) in the OPD group and incidence of any complications of Clavien-Dindo grade II or higher was 23.5% (31/132) versus 34.4% (42/122), respectively. 90 day mortality was 0.8% (1) in the RPD group and 2.5% (3) in the OPD group. Median total costs of hospital admission (including readmission cost) were higher in the RPD group than in the OPD group (¥130 905 (£14 369; $19 351; €16 628) (IQR ¥114 853-¥152 547) v ¥108 071 (¥92 134-¥128 035), difference ¥22 834 (95% CI ¥16 744 to ¥30 522); P<0.001). In high volume centres with credentialled surgeons, RPD met the non-inferiority margin for time from surgery to postoperative functional recovery, with comparable disease related outcomes and overall burden from postoperative complications. To generate wider system level efficiency gains, the implementation of RPD should take account of institutional expertise, procedural volume, acquisition of robotic surgical platforms and maintenance costs, and the potential for shorter hospital stay. ClinicalTrials.gov NCT04400357.
This study investigated whether chronic constipation and diarrhoea are temporally linked to colorectal cancer (CRC) diagnosis, aiming to clarify if these symptoms function as modifiable risk factors or early indicators of malignancy. We conducted a retrospective case-control study using real-world data from the German Disease Analyser database. After 1:5 propensity score matching for age, sex, index year and comorbidities, 10 941 patients with CRC and 54 705 matched controls without cancer were included in the study. Documentation of constipation and diarrhoea was evaluated in six time intervals up to 5 years before CRC diagnosis. Multivariable conditional logistic regression was used to calculate ORs and 95% CIs for CRC risk. Constipation was significantly more frequent in patients with CRC within 6 months prior to CRC diagnosis (OR 3.23; 95% CI 2.85 to 3.66). A similar pattern was observed for diarrhoea within 6 months prior to diagnosis. However, the association was stronger the more frequently diarrhoea was documented (at least one diagnosis: OR 3.37; 95% CI 3.03 to 3.75; at least two diagnoses: OR 4.18; 95% CI 3.31 to 5.28; at least three diagnoses: OR 6.82; 95% CI 4.43 to 10.49). No associations were identified beyond 1 year before diagnosis. Constipation and diarrhoea were associated with the subsequent diagnosis of CRC only in the immediate months before diagnosis, suggesting reverse causality rather than a causal relationship. These symptoms may serve as red flags rather than risk factors, emphasising the need for timely diagnostic evaluation, especially in the presence of persistent changes in bowel habits.
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Closed-source large language models (LLMs) like generative pre-trained transformer 4o (GPT-4o) have shown promise for clinical information extraction but are potentially limited by cost, data security concerns and inflexibility. Open-source models are an attractive alternative with various adaptation strategies with no consensus on best practices. This study aims to rigorously identify optimal adaptation strategies for open-source models and evaluate their performance relative to closed-source alternatives. We studied three LLM adaptation strategies: chain-of-thought prompting, few-shot prompting and fine-tuning. Our target for information extraction was the Mayo Endoscopic Subscore (MES). We applied those strategies in all combinations to six open-source models (8-70 billion parameters) using an annotated set of colonoscopy procedure reports from the University of California, San Francisco (N=608) and San Francisco General Hospital (N=217). We analysed the relationship of these strategies to several performance metrics with a mixed-effects model, accounting for the variability between centres and LLMs. GPT-4o served as a closed-source oracle and provided in-depth commentary on the cost-effectiveness of these options. Quantised low-rank adaptation (QLoRA) statistically improves (p < 0.001) the performance of open-source LLMs by 9.1-15.7 percentage points across accuracy, precision recall and annotation eligibility accuracy. However, GPT-4o with prompt engineering outperforms the best open-source model by 4.9%-11.2%. A simple cost-effectiveness analysis suggests that GPT-4o is more affordable compared with open-source alternatives. GPT-4o is currently the most efficient LLM for MES extraction. If unavailable, QLoRA-optimised open-source models are a competitive alternative. However, results also suggest that current instruction-following LLMs including GPT-4o do not fully follow user-provided instructions, leaving room for improvement. More work is needed to achieve consistent, near-perfect performance in clinical information extraction by LLMs.
To determine whether insufficient balloon dilatation during endoscopic papillary balloon dilatation (EPBD) is associated with postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) and prolonged hospitalisation and to identify clinical and anatomical factors related to insufficient dilatation. Multicentre retrospective cohort study with propensity score matching analysis. Three tertiary referral hospitals in China: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, the Gastroenterology and Endoscopy Center of the First Affiliated Hospital of Sun Yat-Sen University and the First Affiliated Hospital of Shihezi University. Among 3341 patients with choledocholithiasis who underwent EPBD between January 2023 and December 2024, 2970 met the eligibility criteria. After 1:1 propensity score matching, 220 patients were included in the final analysis, including 110 with inadequate balloon dilatation and 110 with adequate dilatation. The primary outcome was the incidence of PEP, diagnosed by standardised criteria. Secondary outcomes included the length of postoperative hospitalisation and risk factors for insufficient balloon dilatation. The incidence of PEP was significantly higher in the insufficient dilatation group compared with the sufficient dilatation group (24.5% vs 8.2%, p=0.002). Multivariate analysis confirmed insufficient dilatation as an independent risk factor for PEP (OR 4.302, 95% CI 1.874 to 9.879, p=0.001), while endoscopic nasobiliary drainage (ENBD) was a protective factor (OR 0.391, 95% CI 0.178 to 0.858, p=0.019). Insufficient dilatation was also associated with a longer postoperative hospital stay (p=0.002). Furthermore, the presence of a juxtapapillary duodenal diverticulum (JDD) was strongly correlated with a lower likelihood of insufficient dilatation (OR 0.388, 95% CI 0.210 to 0.716, p=0.002). Insufficient balloon dilatation during EPBD is a significant risk factor for PEP. ENBD was associated with a reduced risk. Patients with JDD are more likely to achieve sufficient balloon dilatation. Recognising this sign of insufficient dilatation can help clinicians stratify risk and tailor postprocedural management.
To evaluate the relationship between anti-tumour necrosis factor (TNF) use and surgical resection rates in a regional paediatric inflammatory bowel disease (IBD) cohort. This retrospective cohort study used prospectively maintained electronic data from a regional UK paediatric gastroenterology centre (2007-2024). Included were individuals with modified Porto IBD diagnosis, aged ≤17 years. Annual prevalent IBD population was estimated using incident diagnoses and transition to adult services. Abdominal surgery rates (strictureplasty, resection, primary stoma) and anti-TNF administration were collected and prevalence calculated. Three anti-TNF epochs, defined by the European Crohn's and Colitis Organisation/European Society of Paediatric Gastroenterology, Hepatology and Nutrition guidelines in 2014 and 2020, were compared: Epoch-1 (2007-2013; <20% anti-TNF), Epoch-2 (2014-2020; 20%-50%) and Epoch-3 (2021-2024; >50%). Kaplan-Meier analysis with log-rank testing compared surgery-free survival between early and later anti-TNF treatment groups. One thousand five hundred and thirty-eight children were included (915 Crohn's disease (CD), 529 ulcerative colitis (UC) and 94 IBD-unclassified). Median age at diagnosis was 13.3 years, and the prevalent population increased (253-597 patients). Anti-TNF-treated prevalence rose across epochs (5.9%, 31.9%, 61.1%; p<0.001). Resection rates declined 3.93%, 1.57% and 1.09% (Epoch 1-3) (p=0.003). Rates did not significantly decrease from Epoch 2 to 3 (p=0.217). CD surgery significantly decreased (4.9%, 1.7%, 1.5%, p=0.006); trends in UC rates did not reach significance (1.89%, 1.55%, 0.56%, p=0.314). Time to anti-TNF from diagnosis decreased (1.2, 0.8 and 0.26 years, p=0.008). Early vs later anti-TNF initiation was not associated with surgery-free survival. We report a significant increase in anti-TNF prevalence, with earlier deployment. Surgical resection rates have declined and plateaued; reflecting reduced CD surgery. Future research should focus on optimised anti-TNF and second-line biologic deployment to move beyond current levels of surgery.
Chronic obstructive pulmonary disease (COPD) is increasingly recognised as a systemic condition with extrapulmonary comorbidities including malignancy. While the association between COPD and lung cancer is well established, evidence for extrapulmonary cancers, particularly after accounting for lifestyle, demographic and socioeconomic factors, remains limited. We conducted a nationwide population-based cohort study using the Korean National Health Insurance Service-Health Screening Cohort (2002-2019). After exclusions and propensity score overlap weighting, 532 174 patients with COPD and 1 891 601 matched controls were included. COPD and exacerbations were defined using International Classification of Diseases, 10th Revision codes and treatment records. Cox proportional hazards models and E-value analyses were used to estimate associations and assess the potential impact of unmeasured confounding. During up to 16 years of follow-up, COPD was associated with a 52% higher overall cancer risk (HR 1.52, 95% CI 1.50 to 1.53), independent of demographic, lifestyle and clinical factors. Increased risks were observed for 11 of 14 site-specific cancers, with the strongest associations for lung (HR 3.68), bladder (HR 1.58), haematological (HR 1.45) and kidney cancers (HR 1.43). COPD exacerbations were also associated with increased overall cancer risk (HR 1.48, 95% CI 1.46 to 1.50), with broadly similar patterns across site-specific cancers. Associations were consistent across sex, age and smoking strata and were unlikely to be explained by unmeasured confounding based on E-value analyses. COPD and exacerbations were associated with increased risks of overall and multiple site-specific cancers beyond the lungs. These findings support the systemic nature of COPD.
Anti-tumour necrosis factor (anti-TNF) immunogenicity remains a major barrier to treatment persistence in inflammatory bowel disease, yet data from Middle Eastern populations are lacking. We characterised immunogenicity rates, predictors and loss of response mechanisms in a real-world cohort. This retrospective cohort study included 314 anti-TNF treatment courses (212 infliximab, 102 adalimumab) in 248 patients at a tertiary centre in the United Arab Emirates. Immunogenicity was defined by detectable anti-drug antibodies on a drug-tolerant electrochemiluminescent bridging immunoassay with acid dissociation. Drug levels, predictors and loss of response mechanisms were analysed. Immunogenicity developed in 28.3% (89/314) of courses over median follow-up of 24.0 months (median time to detection 15.0 months, IQR 8.0-36.0). Infliximab and adalimumab had comparable rates (26.9% vs 31.4%; p=0.425). Immunogenicity-mediated failure was the leading cause of discontinuation (48.4%). Pre-event trough levels were significantly lower in immunogenic courses (median 3.0 vs 14.0 mcg/mL; p<0.001). Exploratory receiver operating characteristic thresholds of 5.3 mcg/mL for infliximab (area under the curve (AUC) 0.880) and 6.4 mcg/mL for adalimumab (AUC 0.861) predicted immunogenicity with high discrimination. On shared frailty Cox regression, prior surgery was the strongest predictor (HR 1.85, 95% CI 0.94 to 3.64; p=0.074). A sensitivity analysis excluding rescued patients strengthened the surgery signal (HR 2.80, 95% CI 1.41 to 5.56; p=0.003). Subcutaneous infliximab showed lower immunogenicity than intravenous infliximab (new starters 1/25 (4.0%), switchers 1/33 (3.0%) vs IV 57/212 (26.9%)); after propensity score matching on five covariates, the difference remained significant (3.8% vs 18.3%; p=0.013), though a new starters-only analysis did not reach significance (p=0.062). Immunogenicity patterns in this Middle Eastern cohort are consistent with Western data, supporting pharmacokinetic rather than population-specific determinants. These findings suggest a potential benefit of proactive therapeutic drug monitoring and that subcutaneous infliximab may offer an immunogenic advantage warranting prospective validation.
Recurrence of acute pancreatitis (AP) is common, leading to cumulative pancreatic injury and reduced quality of life. While aetiology-based treatments and lifestyle interventions are effective, long-term adherence is often poor due to insufficient health awareness and a lack of continuous reminders. We designed the PROGRESS (PROactive GRadEd follow-up Strategy for reducing recurrence in acute pancreatitiS) trial to evaluate whether a physician-initiated, proactive and graded follow-up strategy can reduce AP recurrence. The PROGRESS trial is a multicentre, open-label, randomised controlled trial. A total of 194 patients with AP will be randomised 1:1 to either a proactive follow-up group or a standard follow-up group. In the proactive follow-up group, patients are stratified into high-risk or low-risk categories based on reported risk factors. Follow-up is conducted via WeChat with varying frequencies: every 3 months for the high-risk group and every 6 months for the low-risk group. The standard follow-up group receives routine discharge education and a 1-month outpatient visit. The primary endpoint is the number of AP recurrence episodes within 24 months post-discharge. Secondary endpoints include AP recurrence rate, progression to chronic pancreatitis, quality of life (Short Form 12 Health Survey), anxiety/depression scores (Generalized Anxiety Disorder-7/Patient Health Questionnaire-9), readmission rates and mortality. Analysis will follow the intention-to-treat principle. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital (No. I-25PJ2556, I-26PJ0895). Ethics approval of each participating centre is required before initiation of patient enrolment. The results of this study will be published in peer-reviewed journals. ChiCTR2500113459 (Chinese Clinical Trial Registry).
A better understanding of key concepts is required to properly characterise intractable constipation (IC). We aimed to determine how IC is defined by Latin and Ibero-American paediatric gastroenterologists. A questionnaire was administered to evaluate concepts supporting the definition and use of a unified term for IC. The collected data were analysed using univariate and bivariate analyses. ORs with their corresponding 95% CIs were calculated, p values <0.05 were statistically significant. A total of 429 paediatric gastroenterologists participated: 45.7% Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition (LASPGHAN) members (group 1), 16.3% Ibero-American LASPGHAN members (group 2) and 38.0% non-LASPGHAN affiliates (group 3). Most respondents considered lower bowel frequency despite receiving 'optimal medical treatment' (94.6%), with 51.0% indicating a period of 2-3 months; defined 'prior treatment failure' as the use of two laxatives (51.7%); selecting the tertiary level care prior to diagnosis (43.1%); wished to include the term 'optimal medical treatment' for diagnostic criteria (93.0%); believed follow-up should be carried out by a paediatrician/specialist (86.7%) and preferred the term refractory constipation (86.7%). When comparing group 1 versus group 2, the Spanish group preferred the term 'treatment-resistant constipation' (OR=1.96; 95% CI 1.08 to 3.55; p=0.0157). Latin and Ibero-American paediatric gastroenterologists prefer replacing the term 'IC' with 'refractory/treatment-resistant constipation' defined as a form of paediatric FC characterised by the persistence of clinically relevant symptoms despite optimal conventional medical treatment, appropriately prescribed, supervised and adhered to for a minimum period of 2-3 months, after structural, neurological and metabolic organic causes have been excluded.
Selective cyclooxygenase-2 (COX-2) inhibitors are often considered when anti-inflammatory analgesia is needed for musculoskeletal pain in patients with inflammatory bowel disease (IBD), but concerns remain about intestinal safety. The clinical evidence on short-term selective COX-2 inhibitor use in IBD, with focus on disease activity outcomes, was reviewed. A prespecified literature search was performed in PubMed and the Cochrane Library supplemented by reference list screening. Clinical trials and clinical studies evaluating celecoxib, etoricoxib or rofecoxib in patients with IBD and musculoskeletal/rheumatological symptoms were considered when gastrointestinal (GI) outcomes were reported. Two placebo-controlled randomised trials did not show higher rates of IBD relapse or symptom aggravation vs placebo during short-term treatment in selected patients, including ulcerative colitis in remission and IBD with rheumatic manifestations. Open-label studies and retrospective series reported variable GI adverse events and occasional symptom worsening, but study populations, baseline disease activity, relapse definitions and follow-up duration differed widely. Overall, the strongest available evidence supports cautious short-term use of selective COX-2 inhibitors in selected patients with IBD in remission when anti-inflammatory analgesia is required. Given the small evidence base and limited follow-up, treatment should be time-limited, use the lowest effective dose and include clinical monitoring.
For surveillance for hepatocellular carcinoma (HCC) to be effective, tests-including imaging, serological biomarkers (conventional and genomic) and algorithms combining multiple tests-must identify early-stage tumours. We aimed to identify, appraise and synthesise studies reporting the accuracy of all such tests in people with cirrhosis. Systematic review and network meta-analysis of diagnostic test accuracy (NMA-DTA) data. MEDLINE and Embase (2005 to September 2025) and a published Cochrane review. English-language, post-2005, one-gate or two-gate studies quantifying diagnostic accuracy of tests to detect HCC in populations wholly comprising people with cirrhosis, excluding those with pre-existing signs and symptoms of HCC. Data extracted by one reviewer, checked by a second and made available in an open-access database. We assessed risk of bias using QUADAS-2. We synthesised data using Bayesian NMA-DTA, accounting for tumour stage and incorporating continuous tests across all possible thresholds. We included 170 studies (62 643 participants). Of 115 index tests, 97 were amenable to NMA-DTA. Ultrasound appears no better than alpha-fetoprotein at detecting very-early-stage HCC (sensitivity 0.34 (95% CrI 0.21 to 0.55) vs 0.39 (95% CrI 0.28 to 0.47)), only becoming superior as stage advances. Least affected by stage are contrast-enhanced MRI (sensitivity 0.70 (95% CrI 0.50 to 0.84) very-early; 0.86 (95% CrI 0.73 to 0.94) early; 0.90 (95% CrI 0.67 to 0.98) advanced) and CT (0.68 (95% CrI 0.26 to 0.93) very-early; 0.77 (95% CrI 0.29 to 0.95) early; 0.92 (95% CrI 0.49 to 0.99) advanced). No genomic biomarkers show convincing improvements over combinations of conventional blood-markers. Most studies are at high risk of bias, but conclusions are robust when restricting to studies with favourable methodological characteristics. Using advanced synthesis methods, we found that tests have low sensitivity for detecting early-stage HCC. Given rising prevalence of cirrhosis and HCC, we need better tests and a stronger evidence-base to inform optimal surveillance strategies. CRD42022357163.
To explore patients' experiences of discharge readiness following acute pancreatitis (AP) and to identify perceived barriers and facilitators influencing readiness for discharge during the transition from hospital to home. A descriptive qualitative study guided by Meleis' Transitions Theory. Emergency and gastroenterology wards of Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. 16 patients with AP were recruited; all 16 eligible patients approached agreed to participate (100% response rate). Data were collected between December 2024 and January 2025 through semistructured in-depth interviews. Data were analysed using Elo and Kyngäs's three-step qualitative content analysis framework, integrating conventional and directed content analysis. The study adhered to the Consolidated Criteria for Reporting Qualitative Research guidelines. Patterns of response reflected variability in patients' psychological adaptation during the transition process, including cognitive-emotional responses and relational interactions. Factors influencing discharge readiness were identified across three theoretical domains. Nature of Transitions captured the dynamics of self-management, including awareness, engagement and behavioural evolution. Transition Conditions reflected the complexity of socioecological determinants, including age and life stage, health literacy, financial resources and occupational and cultural influences. Nursing Therapeutics highlighted the discordance between professional support and patient needs, particularly in relation to information provision, dietary management and care continuity. Building on Meleis' Transitions Theory, this study provides an empirically grounded understanding of discharge readiness among patients with AP as a dynamic, multifactorial process. Our findings extend the theory by demonstrating that discharge readiness is shaped by the interaction between individual self-management, socioecological determinants, psychological adaptations and professional support. Addressing gaps in professional health information, personalised and structured dietary management and continuity of care is essential to enhance discharge readiness and support safe, sustainable recovery.
The incidence of urinary tract tumours is increasing annually, and laparoscopic surgery is currently the predominant surgical method employed in clinical practice. Postoperative gastrointestinal dysfunction (POGD) is one of the most prevalent adverse events associated with patients who receive laparoscopic surgery. Transcutaneous electrical acupoint stimulation (TEAS) may be an effective treatment for POGD. This study intends to evaluate the efficacy and safety of TEAS for POGD following urological laparoscopic surgery. This is a prospective, single-centre, randomised controlled trial. A total of 112 urological patients will be randomly assigned to either the TEAS group or the sham TEAS group at a ratio of 1:1. Each group of patients received a total of two treatments, one prior to surgery and one in the post-anaesthesia recovery room (PACU) after surgery, with each treatment lasting 30 min. The intervention group received TEAS treatment at bilateral Neiguan (PC6), Zusanli (ST36) and Ciliao (BL32) acupoints. Once patients achieved an effective sensation of 'deqi' at these points, the TEAS intensity was adjusted to the maximum tolerable level and maintained for 30 min. The primary outcome will be the score of intake, feeling nauseated, emesis, physical exam and duration of symptoms (I-FEED) on the day 3 postoperatively. The secondary outcomes will include the time of first postoperative flatus and defecation, 5 days postoperative Visual Analogue Scale (VAS) score and the Quality of Recovery Scale (QoR-15), and preoperative 1-day and postoperative 5-day measurements of platelet/lymphocyte ratio (PLR), interleukin-6 (IL-6), interleukin-10 (IL-10), acetylcholine (Ach), norepinephrine (NE) concentration levels, motilin (MTL), and microRNA-10b-5p (miR-10b-5p) concentration levels. The safety of transcutaneous acupoint electrical stimulation will also be evaluated. This study was approved by the Medical Ethics Committee of the First affiliated Hospital of Xiamen University. The results of the study will be disseminated through a variety of channels, including peer-reviewed open-access publications, scientific conferences and targeted communications with patient organisations, healthcare providers and the broader public. NCT07133620.
Obesity and related cardiometabolic comorbidities, including hypertension, dyslipidaemia, diabetes, metabolic dysfunction-associated steatotic liver disease and atherosclerotic cardiovascular disease, are increasingly prevalent among individuals with inflammatory bowel disease (IBD). These conditions influence disease activity, therapeutic response, surgical outcomes and overall quality of life, yet evidence remains fragmented. The Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD) initiative aims to synthesise evidence and generate consensus recommendations to guide practice and future research in this area. This study describes a protocol for a structured evidence synthesis and Research ANd Development/University of California, Los Angeles (RAND/UCLA) Appropriateness Method (RUAM) consensus process. We will conduct three systematic reviews and a structured evidence synthesis organised into three domains: (1) the impact of obesity on IBD outcomes, (2) the burden of cardiometabolic complications in IBD and (3) the management of overweight, obesity and cardiometabolic comorbidities in IBD. A multidisciplinary international panel of gastroenterologists, surgeons, endocrinologists, hepatologists, cardiologists and dietitians will assess each statement using the RAND/UCLA appropriateness method. Panellists will rate the appropriateness of each statement (only those that fall within their area of expertise) on a 1-9 scale (1-3=inappropriate, 4-6=uncertain and 7-9=appropriate), with medians rounded up (eg, 6.5=appropriate). Agreement will be assessed using the RAND Disagreement Index (DI<1.0=agreement). This study will not involve direct patient participation, as it is based on evidence synthesis and expert consensus; therefore, formal research ethics committee approval will not be required. Patient representatives will contribute to the consensus process to provide contextual perspectives but no identifiable data will be collected.Findings will be disseminated through publication in peer-reviewed journals, presentation at major gastroenterology and IBD conferences and communication with professional societies. A lay summary and patient-friendly infographic will also be developed to facilitate translation of recommendations into clinical practice. CRD420251178843: a systematic review of the impact of obesity on inflammatory bowel disease outcomes.CRD420251178799: a systematic review of cardiometabolic complications in inflammatory bowel disease.CRD420251174653: management of overweight, obesity and cardiometabolic comorbidities in inflammatory bowel disease: a systematic review.
Postoperative nausea and vomiting (PONV) remains one of the most common complications after laparoscopic cholecystectomy, especially in female patients faced with high baseline risk. Although multimodal antiemetic strategies are routinely used in perioperative care, opioid exposure remains an important contributor to PONV. Tegileridine, a novel G protein-biased μ-opioid receptor agonist, may provide effective analgesia with fewer gastrointestinal adverse effects than conventional opioids such as sufentanil. However, evidence on its role in preventing PONV in female patients undergoing laparoscopic cholecystectomy remains limited. This dual-centre, randomised controlled trial will enrol 148 female patients undergoing elective laparoscopic cholecystectomy at two tertiary hospitals in Chengdu, China. Participants will be randomly assigned individually (1:1 ratio) to receive either tegileridine-based or sufentanil-based perioperative analgesia within a standardised multimodal antiemetic framework. Randomisation will be centrally performed using a web-based system with allocation concealment. Participants, postoperative outcome assessors and data analysts will remain blinded to treatment allocation. The primary outcome will be the overall incidence of PONV within 24 hours after surgery. Secondary outcomes will include the incidence and severity of nausea and vomiting at predefined postoperative time points, pain scores, use of rescue analgesic and antiemetic medication, quality of recovery, opioid-related adverse events and recovery-related time-dependent outcomes. This study has been approved by the ethics committees of West China Hospital, Sichuan University and West China Tianfu Hospital, Sichuan University (ethical review no. 1775.2025). Written informed consent will be obtained from all participants before enrolment. The findings will be disseminated through peer-reviewed publications and academic conferences. ChiCTR2500111528.
Postoperative nausea and vomiting (PONV) is a common and distressing complication following surgery, persisting despite advances in prophylactic regimens. Growth differentiation factor-15 (GDF-15) has been identified as a biomarker inversely associated with PONV risk and severity. As metformin is known to elevate circulating GDF-15 levels, we hypothesise that preoperative metformin use may be associated with a lower incidence of PONV. This study aims to evaluate the association between a history of preoperative metformin administration and the occurrence of PONV in adults undergoing general anaesthesia. This is a single-centre, prospective, observational cohort study. We plan to enrol 909 adult patients scheduled for surgery under general anaesthesia with endotracheal intubation from December 2025 to December 2028. Participants will be divided into two groups based on their preoperative metformin exposure: an exposed group (n=303) with a documented history of metformin use and a non-exposed group (n=606) without such history, using a 1:2 ratio. The metformin regimen (choice of agent and daily dosage) will be determined by the attending physician as part of routine clinical care, independent of this study. The primary outcome is the incidence of PONV, defined as the occurrence of any nausea, retching or vomiting, within 120 hours post-surgery. Secondary outcomes include the incidence of PONV in the early (0-24 hours) and late (24-120 hours) postoperative phases; the severity of PONV symptoms and the requirement for rescue antiemetic medication during these intervals; the quality of recovery (assessed at 0-24, 24-48, 48-72, 72-96 and 96-120 hours); potential PONV risk factors in blood or urine and long-term survival rates at 1, 3 and 5 years. This study protocol (version 04, dated 23 November 2025) was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (Approval No. 2025ZSLYEC-689) prior to the initiation of participant recruitment. The first participant was enrolled under protocol version 04. A subsequent protocol amendment (version 05, dated 25 December 2025) was approved by the same Ethics Committee. This amendment added a quality of recovery assessment using the 15-item quality of recovery scoring system questionnaire at 30 days postoperatively. This amendment did not alter the primary or secondary outcomes, the sample size calculation, or any other key elements of the study design. The results of this study will be disseminated at scientific conferences and published in international peer-reviewed journals. NCT07244575.
To identify risk factors and examine associations between colorectal cancer (CRC) status and modifiable and non-modifiable risk factors among patients diagnosed in Oman, considering the existence and increase of incidence and prevalence of these risk factors. A multicentre case-control study. Sultan Qaboos University Hospital and the Royal Hospital in Muscat, Oman. Patients diagnosed with CRC (n=166) and controls (n=166). A questionnaire adapted from the Colon Cancer Family Registry and other previously published studies was used to collect data on sociodemographic characteristics, modifiable and non-modifiable CRC risk factors and coexisting morbidities. Univariable and multivariable logistic regression analyses were performed to examine associations between CRC status and independent variables. Multivariable analysis demonstrated significant associations between CRC status and several risk factors. Smoking was associated with a fourfold increased risk of CRC (adjusted OR (aOR): 4.35, 95% CI 2.26 to 8.36). Higher body mass index was also associated with increased CRC risk (aOR: 2.42, 95% CI 1.23 to 4.76), while individuals with a family history of CRC, including first-degree relatives (biological parents, siblings and children) and second-degree relatives (grandparents, uncles and aunts) had more than double the risk (aOR: 2.10, 95% CI 1.15 to 3.82). Also, polyps had double the risk (aOR 2.61, 95% CI 1.40 to 4.84) In addition, CRC was more common among patients with diabetes (aOR 2.70, 95% CI 1.52 to 4.80), hypertension (aOR 4.13, 95% CI 2.03 to 8.42) and inflammatory bowel disease (aOR 3.48, 95% CI 1.13 to 10.67). Considering the existence of non-modifiable risk factors and the increase in incidence and prevalence of modifiable risk factors of CRC in Oman, the findings of this study underscore the need for targeted awareness initiatives, risk-based screening and early surveillance, particularly among high-risk groups. The results also support integrating smoking cessation, weight management and optimal control of chronic diseases into national CRC prevention programmes to reduce the overall CRC disease burden.