Trials最新文献

{"title":"Treatment of genitourinary syndrome of menopause with fractional CO₂ laser versus fractional microablative radiofrequency: study protocol for a double-blind, randomised, non-inferiority trial.","authors":"Cássia Caroline Garcia Dalbem Teles, Catarina Maria Mesquita Garcia Dalbem, Matheus Rodrigues de Souza, Nivaldo Antonio Parizotto","doi":"10.1186/s13063-026-09865-3","DOIUrl":"10.1186/s13063-026-09865-3","url":null,"abstract":"<p><strong>Background: </strong>Genitourinary syndrome of menopause (GSM) affects a significant proportion of postmenopausal women, leading to symptoms such as vaginal dryness, irritation, dyspareunia, and urinary symptoms. Hormonal therapies are not suitable for all patients, particularly those with contraindications to hormone use. This study aims to compare the efficacy and safety of two non-hormonal therapies-fractional CO₂ laser (CO₂ laser) and fractional microablative radiofrequency (MAFRF)-for the treatment of GSM.</p><p><strong>Methods: </strong>This protocol describes a randomised, double-blind, non-inferiority clinical trial that will enrol 40 postmenopausal women diagnosed with GSM. Participants will be randomised to receive either fractional CO₂ laser or fractional microablative radiofrequency in three monthly sessions. The primary outcome will be the Vaginal Health Index Score (VHIS), assessed 30 days after the last treatment session (day 90). Secondary outcomes include sexual function, GSM symptom severity, and urinary symptoms. Follow-up assessments will be conducted at 120 and 300 days after the last session (days 180 and 365, respectively). Histological analysis of vaginal biopsies will be performed in a predefined subsample of participants as an exploratory analysis.</p><p><strong>Discussion: </strong>This study is expected to contribute to the comparative understanding of the efficacy and safety of CO₂ laser and MAFRF as non-hormonal therapeutic options for the treatment of GSM, potentially supporting clinical decision-making for women who are not candidates for hormonal therapy.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trials Registry (ReBEC): RBR-2hgwvgy. The trial was registered retrospectively due to administrative delays in the registration process. However, no outcome data were accessed, analysed, or used to inform any decisions prior to registration, and no interim analyses were performed. Additionally, no modifications were made to the study design, outcomes, or planned analyses after the initiation of data collection. Registered on July 2, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13617837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of early tracheostomy in infratentorial lesions trial: rationale and design.","authors":"Song Han, Meng-Ya Li, Yuan-Chao Cheng, Chang-Xiang Yan","doi":"10.1186/s13063-024-08682-w","DOIUrl":"10.1186/s13063-024-08682-w","url":null,"abstract":"<p><strong>Background: </strong>Tracheostomy is a common procedure in patients who undergo surgical resection of infratentorial lesions. However, the optimal timing and high-risk factors for tracheostomy remain unknown.</p><p><strong>Methods: </strong>Value of Early versus Standard Tracheostomy in patients with Infratentorial Lesions (VENTIL) is a prospective, randomized, controlled, open-blinded endpoint (PROBE design) trial. Patients who have undergone resection of infratentorial lesions will be recruited within 48 h postoperatively based on a prediction score. This study will include 152 patients. Patients will be randomized 1:1 to either the early tracheostomy (< 2 days after surgery) or the control group (≥ 2 days after surgery). The primary endpoint is the occurrence of pneumonia by day 14 after resection of infratentorial lesions. The secondary endpoints include the modified Rankin scale score at 6 months, mortality, length of intensive care unit and hospital stays, time to successful extubation, and adverse events.</p><p><strong>Conclusion: </strong>High-risk factors and optimal timing for tracheostomy in patients undergoing resection of infratentorial lesions need to be identified. Therefore, VENTIL should clarify the clinical benefits of early tracheostomy in these patients.</p><p><strong>Trial registration: </strong>This trial is registered on February 5, 2024, at chictr.org.cn (ChiCTR2400080714).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13673802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EECP intervention and coronary flow reserve in chronic coronary syndrome: a protocol of a multicentre, randomised controlled study in China (ECP-Core Trial).","authors":"Yanlong Leng, Yuan Li, Xue Jia, Shuai Tian, Yundan Jiang, Ling Lin, Yinfen Wang, Wei Pan, Jianwen Liang, Fensheng Wu, Wenjuan Zhou, Zhijuan Liao, Xinxia Zhang, Guifu Wu","doi":"10.1186/s13063-026-09878-y","DOIUrl":"10.1186/s13063-026-09878-y","url":null,"abstract":"<p><strong>Background: </strong>Few non-invasive approaches are available for improving coronary function in intermediate-risk chronic coronary syndrome (CCS) patients. Over the past 30 years, enhanced external counterpulsation (EECP) has been widely accepted and recommended for treating CCS in clinical guidelines. However, the effect of EECP on coronary function remains to be quantitatively validated in intermediate-risk CCS patients. Fractional flow reserve (FFR) is a gold standard (quantitative index) of coronary artery function, and FFR < 0.80 is regarded as an indicator for percutaneous coronary intervention (PCI) in clinical decision-making. However, FFR is invasive and cannot be performed repeatedly within a short time interval; therefore, FFR is not suitable for large-scale verification of the effect before and after EECP treatment. Conversely, with advancements in numerical theory and computation hardware, FFR derived from coronary computed tomography angiography (FFR_CT) performs similarly to FFR used in coronary artery function measurement. Additionally, FFR_CT is non-invasive and highly acceptable to patients. Therefore, in this study, we aim to explore whether EECP therapy can improve FFR_CT in patients with intermediate-risk CCS and further enhance the long-term prognosis of CCS.</p><p><strong>Methods: </strong>This prospective, multicentre, randomised controlled trial is blinded to the examination executors and analysts. One hundred four participants will be recruited, and they will be divided into the EECP and control groups. The primary outcome of this study is the between-group difference in FFR_CT changes from baseline to follow-up. The secondary outcomes refer to between-group differences in ΔFFR_CT, wall shear stress, axial plaque stress, total exercise time, time to 1 mm ST-segment depression, Seattle Angina Questionnaire score, and cardiovascular-related composite endpoint events.</p><p><strong>Discussion: </strong>This is the first study to use the non-invasive coronary artery function index, FFR_CT, to evaluate the efficacy of EECP in patients with CCS. It comprehensively evaluates the treatment efficacy from multiple dimensions, including exercise capacity, symptom changes, and prognosis. Therefore, this will potentially provide reliable evidence to inform treatment strategies for CCS.</p><p><strong>Trial registration: </strong>Trial registration number: ChiCTR2400079915. Registered on January 16, 2024 (retrospectively registered), https://www.chictr.org.cn/about.html .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602779/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148382422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cheek acupuncture for enhancing postoperative recovery after endoscopic sinus surgery: study protocol for a pilot randomized controlled trial.","authors":"Meng Wang, Guiyu Lei, Jun Yan, Guyan Wang","doi":"10.1186/s13063-026-09875-1","DOIUrl":"10.1186/s13063-026-09875-1","url":null,"abstract":"<p><strong>Background: </strong>Postoperative pain and sleep disturbance are common after endoscopic sinus surgery (ESS) and may delay postoperative recovery. Acupuncture has demonstrated analgesic and sleep-enhancing effects in perioperative care; however, the impact of cheek acupuncture-a minimally invasive facial microsystem technique-on postoperative recovery after ESS has not been evaluated in randomized controlled trials.</p><p><strong>Methods: </strong>This single-center, prospective, randomized controlled pilot trial will enroll 90 adults undergoing ESS. Participants will be randomized 1:1 to receive cheek acupuncture or sham cheek acupuncture within 30 min before anesthesia induction. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 h postoperatively. Secondary outcomes include the Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) for pain, intraoperative hemodynamics, postoperative care unit (PACU) stay duration, postoperative nausea and vomiting (PONV), and inflammatory biomarkers (serum interleukin-6 [IL-6] and C-reactive protein [CRP]).</p><p><strong>Discussion: </strong>This trial will assess the feasibility, safety, and preliminary efficacy of cheek acupuncture in improving postoperative recovery after ESS. Results will inform the design of a future multicenter randomized trial.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR2500110625). Registered on 16 October 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13595525/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148369896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of transcranial direct current stimulation for post-stroke urinary incontinence: study protocol for a randomized controlled trial.","authors":"Gen Ran, Yuling Chen, Yali Feng, Botao Tan, Yi Zhou, Wei Jiang, Lanjie Xiao","doi":"10.1186/s13063-026-09866-2","DOIUrl":"10.1186/s13063-026-09866-2","url":null,"abstract":"<p><strong>Background: </strong>Post-stroke urinary incontinence is a prevalent and debilitating complication that severely impacts patient recovery and quality of life. Although pelvic floor muscle training is a recognized standard rehabilitative intervention, its clinical efficacy in stroke survivors is often suboptimal, largely because it addresses peripheral muscle function without mitigating the underlying central neurological deficits that disrupt micturition control. Emerging evidence suggests that neuromodulation via transcranial direct current stimulation can enhance neuroplasticity in cortical motor areas. This trial aims to address the current therapeutic gap by evaluating whether the synergistic combination of central neuromodulation and peripheral muscle training provides superior therapeutic benefits for post-stroke urinary incontinence recovery compared to pelvic floor muscle training alone.</p><p><strong>Methods: </strong>This randomized controlled trial will randomly assign an aggregate of 50 eligible patients into two groups. Participants allocated to the intervention group (n = 25) will undergo PFMT coupled with active, low-frequency tDCS over M1, whereas those in the control group will receive identical PFMT alongside sham tDCS. The 20 treatment sessions will be administered on a schedule of five sessions per week across four consecutive weeks for every participant. The primary outcome is leakage episodes. The secondary outcomes are defined as simplified cystometry, the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), Overactive Bladder Symptom Score (OABSS), Incontinence Quality of Life Questionnaire Score (I-QOL), surface electromyography (sEMG), Neurogenic Bowel Dysfunction Score and the number of urinations.</p><p><strong>Discussion: </strong>This randomized controlled trial protocol evaluates a novel intervention combining tDCS targeting the contralesional M1 with PFMT for post-stroke urinary incontinence. To address a critical gap in stroke rehabilitation, the study designs a rigorous double-blind, sham-controlled design to explore the combined effects of central neuromodulation and peripheral muscle training. A comprehensive assessment will be used to generate robust evidence of this innovative intervention. The findings are expected to contribute to an effective neurorehabilitation strategy, potentially transforming clinical approaches to this common yet under-addressed complication and significantly enhancing the quality of life for stroke survivors.</p><p><strong>Trial registration: </strong>URL: https://www.chictr.org.cn ; Unique identifier: ChiCTR2500099178. Registered on 2025-03-19.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13573409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148377151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Compression therapies for the treatment of venous leg ulcers: a mixed method process evaluation in a randomised controlled trial, VenUS6.","authors":"Maartje Kletter, Jane Griffiths, Catherine Arundel, Jo Dumville","doi":"10.1186/s13063-026-09854-6","DOIUrl":"10.1186/s13063-026-09854-6","url":null,"abstract":"<p><strong>Background: </strong>Strong compression treatment is an evidence-based first-line treatment that helps reduce the healing time of venous leg ulcers. VenUS 6 is a three-arm RCT conducted in the UK that aimed to compare 4-layer bandages and 2-layer hosiery with compression wraps and 2-layer bandages. The study found that compression wraps are unlikely to reduce time to venous leg ulcer healing compared to the other treatments evaluate, although there was some uncertainty with this estimate. We nested a mixed-methods process evaluation within VenUS 6 to gain a more in-depth understanding of trial participant and nursing staff views on and experiences of various compression therapies, and to consider how these insights may explain VenUS 6 outcomes.</p><p><strong>Methods: </strong>We conducted individual, in-depth interviews with 11 trial participants and focus group discussions with 19 relevant health professionals based at seven participating primary, secondary and community care NHS Trust sites. We also used data collected during the trial from patients about their experience of compression use. We conducted a separate UK-wide survey with nurses to learn more about availability of the trial compression treatment options in clinics and their views on the ease of use of the compression treatments in scope. Qualitative data were analysed using framework analysis and quantitative data were analysed descriptively. Data were integrated with the help of the Pillar Integration Process.</p><p><strong>Results: </strong>There was high satisfaction with compression wraps and limited discomfort among trial participants, who appreciated the wraps could be adjusted and taken off to allow them to take showers. Staff mentioned, however, that trial participants were prone to loosen the wraps. Whilst 2-layer hosiery allowed for self-application and could be taken off, trial participants said the hosiery was very tight and difficult to apply. Bandages, on the other hand, whilst bulky and sometimes uncomfortable, would often not be removed by trial participants, leading to greater exposure to effective compression.</p><p><strong>Conclusion: </strong>We have identified that people with venous ulcers wearing compression wraps are more likely to report loosening them and removal at night, than people wearing other types of compression treatment which was confirmed by staff. These reported behaviours could explain longer healing times for compression wraps, compared to other treatments delivered in our RCT. Despite longer times to healing, compression wraps may still be an appropriate compression treatment option for some people, and it is important for nursing staff to have conversations with service users and share decisions about suitable treatment options.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13595631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148369950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological guidance for incorporating lived experience in the early stages of core outcome set development: a scoping review.","authors":"Marci Kay Livingston, Elaine Toomey, Katie Robinson","doi":"10.1186/s13063-026-09848-4","DOIUrl":"10.1186/s13063-026-09848-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Core Outcome Sets (COS) provide a systematic approach to ensuring that outcomes measured in health research matter to the individuals most affected by the research. While methodological guidance generally exists for COS development, specific guidance on incorporating the perspectives of people with lived experience (PWLE) during the long-list stage remains fragmented and unclear. This stage is crucial for including outcomes that matter to those directly impacted. Therefore, this scoping review aims to systematically identify and chart the available methodological literature on incorporating the perspectives of PWLE into the long-list generation stage of COS development.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This review followed JBI guidance for scoping reviews and adhered to PRISMA-ScR reporting standards. A comprehensive search was conducted across multiple databases (MEDLINE, Embase, Scopus, CINAHL, ProQuest Theses & Dissertations, and the COMET Database) on 31 October 2024. In addition, a citation search of all included articles and further expert consultation were included to ensure that all relevant articles were identified. Articles were eligible for inclusion if they provided methodological guidance, recommendations and/or insight into how best to include the perspectives of PWLE into the long-list stage of COS development. Screening and data extraction were completed by two independent reviewers. The analysis was guided by a combined deductive-inductive qualitative content analysis process. Categories were developed from the data and synthesised into practical recommendations for COS developers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 45 articles were included. The analysis yielded four major categories of guidance: (1) PWLE Identification, Recruitment, and Engagement; (2) Data Collection Considerations; (3) Analysis and Reporting; and (4) Contextual Considerations. The results highlight an evolving methodological landscape surrounding PWLE perspective integration into COS development. The results emphasise the importance of purposeful and reflexive methodological choices and underscore the importance of utilising existing qualitative research, participatory action research (PAR), reporting standards, and existing equity, diversity, and inclusion principles throughout the long-list process.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This review identified a growing but uncoordinated body of methodological guidance for including the perspectives of PWLE into the long-list stage of COS development. The findings will support future COS developers in making methodologically rigorous decisions. Future research should aim to validate these findings and recommendations through empirical work with COS developers and PWLE, informing the co-production of best practice guidelines.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;This review is registered in the COMET Database: https://www.comet-initiative.org/Studies/Details/3590 . T","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial.","authors":"Anna Schäfer, Julia Wendel, Isabella Franke, Armin Bauer, Harald Baumeister, Eileen Bendig, Sara Y Brucker, Thomas M Deutsch, Patricia Garatva, Kirsten Haas, Lorenz Heil, Klemens Hügen, Helena Manger, Rüdiger Pryss, Viktoria Rücker, Jessica Salmen, Andrea Szczesny, Carsten Vogel, Markus Wallwiener, Achim Wöckel, Peter U Heuschmann","doi":"10.1186/s13063-026-09858-2","DOIUrl":"10.1186/s13063-026-09858-2","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13317311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"IMPACT-Introduction of Mycotic Prophylaxis At Cystectomy Trial: perioperative mycotic prophylaxis with fluconazole to reduce postoperative complications following cystectomy-study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial.","authors":"Mie Skjøttgaard Ynddal, Hein Vincent Stroomberg, Maja Vejlgaard, Jørgen Bjerggaard Jensen, Claus Moser, Ulla Nordström Joensen, Andreas Røder","doi":"10.1186/s13063-026-09862-6","DOIUrl":"10.1186/s13063-026-09862-6","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>Cystectomy with urinary diversion is one of the most complex surgeries in the urological specialty involving surgery on multiple organ systems. The postoperative risk of mortality and complications is considerable, and the first months after surgery are often the most critical. When creating the urinary diversion, the abdominal cavity is exposed to bacteria and fungus from the small intestine, and after the surgery, micro-leakage from the intestinal anastomosis may also contribute to a local infectious response. This contamination is suspected to increase the risk of bowel paralysis that, even with modern ERAS protocols, significantly impacts the postoperative recovery. Emerging data show that approximately 50% of the patients undergoing cystectomy have Candida albicans in samples from the terminal ileum. Current guidelines support the use of perioperative antibiotics, but there are currently no guidelines on antimycotic prophylaxis. We present a randomized clinical trial that tests whether incorporating antimycotics into the perioperative antimicrobial prophylactic regimen can reduce major complications after cystectomy.</p><p><strong>Materials and methods: </strong>This is a multi-center, double-blinded, randomized clinical trial including participants from all five centers in Denmark performing cystectomy. The study includes adult patients planned for cystectomy with an ileal conduit with no contraindications to fluconazole and no active treatment for mycotic infections. The 420 participants are randomized 1:1 to receive a single dose of perioperative fluconazole or placebo. Primary outcome is major postoperative complications, defined as Clavien-Dindo classification III-V, within 90 days following cystectomy. Secondary outcomes are days alive and out of hospital, gastrointestinal function, nasogastric tube placement, length of stay, readmissions, quality of life, and microbiological test results. We aim to reduce the absolute rate of Clavien-Dindo III-V complications from 30 to 18%. The study is a superiority study and analysis will be performed as intention-to-treat.</p><p><strong>Discussion: </strong>Patients undergoing cystectomy face a high risk of surgical complications, many of which can be attributed to infections. There is a growing concern about the consequences of fungal infections after abdominal surgery. This trial aims to explore whether prophylactic antifungal treatment at the time of cystectomy can prevent major postoperative complications.</p><p><strong>Trial registration: </strong>CTIS EU trial number: 2023-506226-36-00. Registered on February 16, 2024.</p><p><strong>Clinicaltrials: </strong>gov: NCT06770530. Registered on March 31, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148362391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adjunctive optical and magnetic stimulation for venous and mixed etiology leg ulcers: protocol for the NAZARÉ multicenter randomized controlled trial.","authors":"Sebastian Probst, Camille Saini, Alessio Stefanelli, André Frei, Ewa Klara Stuermer, Joachim Dissemond, Lars-Peter Kamolz, Benedikt Weber, Jean-Paul Lembelembe, Jürg Traber, Dieter Mayer, Thomas Zehnder, Dave Baer, Claudio Ruzza, Jürg Hafner","doi":"10.1186/s13063-026-09859-1","DOIUrl":"10.1186/s13063-026-09859-1","url":null,"abstract":"<p><strong>Background: </strong>Venous leg ulcers (VLUs) and VLUs associated with peripheral arterial disease (PAD) are common, recurrent, and costly to manage. Adjunctive biophysical therapies may improve healing outcomes when combined with standard of care (SOC). Concurrent optical and magnetic stimulation (COMS) has shown promising mechanistic and preliminary clinical results but there is a lack of robust randomized controlled trials (RCTs).</p><p><strong>Method: </strong>This novel adjunct using concurrent optical and magnetic stimulation in a multicenter RCT in Europe (NAZARÉ) is a phase IV, post-market, multicenter, parallel-group, superiority randomized controlled trial conducted in Switzerland, France, Germany, and Austria. A total of 122 adults with VLU or mixed leg ulcers (ankle-brachial index > 0.5 and < 1.30 or ankle artery pressure > 60 mmHg), ulcer area 2-50 cm², and ulcer duration > 30 days and < 2 years will be enrolled. Following a 2-week run-in to confirm < 30% area reduction under SOC, participants will be randomized 1:1 to SOC + COMS or SOC alone. The primary outcome is percentage wound area reduction (PWAR) at week 12, assessed by blinded evaluators using standardized digital planimetry. Secondary outcomes include complete closure, time-to-healing, pain, health-related quality of life, recurrence, and healthcare resource use. Missing outcome data will primarily be analyzed as observed and may be addressed using multiple imputation under the assumption of data being missing at random.</p><p><strong>Discussion: </strong>This trial will rigorously assess the effectiveness of COMS as an adjunct to standard care for venous and mixed leg ulcers. By targeting chronic wounds and using a pragmatic, multicenter design, it aims to generate robust, generalizable evidence. If effective, COMS could offer a non-invasive, accessible option to enhance healing outcomes and reduce the burden of chronic leg ulcers.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov NCT06528873. Registred on 26 July 2024, https://register.</p><p><strong>Clinicaltrials: </strong>gov/prs/app/action/SelectProtocol?selectaction=Edit&sid=S000ERKB&uid=U0003LG4 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148346397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}