Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Ventrículos Cardíacos/anatomía & histología , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como AsuntoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Ventrículos Cardíacos/anatomía & histología , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como AsuntoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como Asunto , Ventrículos Cardíacos/anatomía & histologíaRESUMEN
INTRODUCTION: Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate. METHODS AND ANALYSIS: This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King's Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER : NCT05798403.
Asunto(s)
Electroacupuntura , Antagonistas Muscarínicos , Succinato de Solifenacina , Vejiga Urinaria Hiperactiva , Humanos , Succinato de Solifenacina/uso terapéutico , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Femenino , Electroacupuntura/métodos , Antagonistas Muscarínicos/uso terapéutico , Adulto , Persona de Mediana Edad , Calidad de Vida , Método Simple Ciego , Estudios Multicéntricos como Asunto , Resultado del Tratamiento , Estudios de Equivalencia como Asunto , Agentes Urológicos/uso terapéutico , AncianoRESUMEN
BACKGROUND: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking. METHODS: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (⦠cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. DISCUSSION: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05180864. Registered on 6th January 2022.
Asunto(s)
Estudios de Equivalencia como Asunto , Gastrectomía , Estudios Multicéntricos como Asunto , Epiplón , Neoplasias Gástricas , Humanos , Epiplón/cirugía , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Gastrectomía/efectos adversos , Gastrectomía/métodos , Resultado del Tratamiento , Factores de Tiempo , Calidad de Vida , Adulto , Ensayos Clínicos Controlados Aleatorios como Asunto , Masculino , Persona de Mediana Edad , Femenino , Anciano , Escisión del Ganglio Linfático/efectos adversos , Tratamientos Conservadores del Órgano/métodos , Tratamientos Conservadores del Órgano/efectos adversos , Supervivencia sin EnfermedadAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Aorta Torácica/anatomía & histología , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estudios de Equivalencia como Asunto , Ventrículos Cardíacos/anatomía & histología , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentaciónRESUMEN
INTRODUCTION: Sentinel lymph node biopsy (SLNB) is a standard procedure for patients with clinically assessed negative axillary lymph nodes (cN0) during early-stage breast cancer (EBC). However, the majority of EBC patients have a negative pathological confirmation of the sentinel lymph node (SLN), and axillary surgery is inevitably associated with postoperative complications. Considering that SLNB has no therapeutic benefit, this trial aims to determine the safety of omitting SLNB in patients with cN0 early invasive breast cancer. METHODS AND ANALYSIS: The OMSLNB trial is a prospective, single-arm, non-inferiority, phase II, open-label study design involving female breast cancer patients with a tumor of ≤3 cm in diameter, who are considered axillary lymph-node-negative based on two or more radiological examinations, including axillary lymph node ultrasonography. Eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery. The trial begins in 2023 and is scheduled to end in 2027. The primary endpoint is 3 year invasive disease-free survival (iDFS). The secondary endpoints include the incidence of breast cancer-related lymphoedema, patient-reported outcomes, locoregional recurrence, local recurrence and regional recurrence. It is expected that the 3 year iDFS in patients undergoing SLNB is about 90%, combined with a non-inferiority cut-off of 5%, 80% power, 95% CIs, 0.05 test level, and 10% loss to follow-up rate, the planned enrollment is 311 patients. All enrolled patients will be included in the intention-to-treat analysis. ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (No.2023-SR-193). All participants must provide written informed consent to be eligible. The protocol will be described in a peer-reviewed manuscript, and the results will be published in scientific journals and/or at academic conferences. TRIAL REGISTRATION NUMBER: NCT05935150.
Asunto(s)
Axila , Neoplasias de la Mama , Biopsia del Ganglio Linfático Centinela , Humanos , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Femenino , Biopsia del Ganglio Linfático Centinela/métodos , Estudios Prospectivos , China , Adulto , Persona de Mediana Edad , Anciano , Ensayos Clínicos Fase II como Asunto , Ganglios Linfáticos/patología , Estudios de Equivalencia como Asunto , Metástasis Linfática , Ganglio Linfático Centinela/patologíaRESUMEN
BACKGROUND: A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). METHODS: SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. DISCUSSION: The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
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Procedimientos Quirúrgicos Ambulatorios , Apendicectomía , Apendicitis , Estudios Multicéntricos como Asunto , Humanos , Apendicectomía/efectos adversos , Apendicectomía/métodos , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/métodos , Estudios Prospectivos , Apendicitis/cirugía , Apendicitis/mortalidad , Persona de Mediana Edad , Adulto , Adolescente , Anciano , Adulto Joven , Francia , Resultado del Tratamiento , Femenino , Factores de Tiempo , Laparoscopía/efectos adversos , Laparoscopía/métodos , Tiempo de Internación , Masculino , Estudios de Equivalencia como Asunto , Calidad de Vida , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como AsuntoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Aorta Torácica/anatomía & histología , Estudios de Equivalencia como Asunto , Ventrículos Cardíacos/anatomía & histologíaRESUMEN
BACKGROUND: Non-specific low back pain is a common and costly global issue. Many people with low back pain live for years with ongoing symptom recurrence and disability, making it crucial to find effective prevention strategies. Motivational interviewing (MI) is an evidence-based patient-centred counselling style that helps motivate individuals to change their behaviours. In combination, MI and cognitive-behavioural therapy (MI-CBT) has the potential to yield long term improvements in pain and disability and reduce incidence of recurrence. METHOD: This is a two-arm superiority randomised controlled trial comparing MI-CBT and Education (n = 83) with Education only (n = 83). Participants that have recovered from a recent episode of non-specific low back pain (7th consecutive day with pain ≤ 2 on a 0-10 numeric pain rating scale) will be eligible for inclusion into the study. Both groups will receive five 30-min sessions over a 10-week period as well as the Navigating Pain booklet, homework book and a standardised exercise programme. In the intervention group, MI-CBT techniques will be used to provide individualised support, identify beliefs, and increase engagement with the resources provided. Outcomes measures include pain (current and in the last 7 days) as rated on the numeric pain rating scale. This will be used to determine recurrence (number of participants who report back pain ≥ 3 out of 10 on the numeric pain rating scale). Furthermore, self-reported (1) pain intensity; (2) pain catastrophizing; (3) fear-avoidance beliefs; (4) pain self-efficacy; (5) depression and anxiety; (6) disability will be measured. All outcomes will be measured at baseline, and again at 3-, 6-, and 12-months post allocation. DISCUSSION: The effective delivery of self-management strategies to prevent recurrence of low back pain is an important aspect that requires urgent attention. This study will provide new information on the effectiveness of using an MI-CBT approach to facilitate self-management through education and exercise to improve low back pain outcomes. Evidence emerging from this trial has the potential to inform clinical practice and healthcare management of non-specific low back pain. TRIAL REGISTRATION: Prospectively registered with Australian New Zealand Clinical Trials Registry: ACTRN12623000746639 (10/07/2023).
Asunto(s)
Terapia Cognitivo-Conductual , Dolor de la Región Lumbar , Entrevista Motivacional , Educación del Paciente como Asunto , Humanos , Entrevista Motivacional/métodos , Dolor de la Región Lumbar/terapia , Terapia Cognitivo-Conductual/métodos , Educación del Paciente como Asunto/métodos , Terapia por Ejercicio/métodos , Recurrencia , Adulto , Masculino , Estudios de Equivalencia como AsuntoRESUMEN
BACKGROUND: Nowadays, stabilization splints for the management of bruxism and temporomandibular disorders (TMD) can be produced utilizing a digital workflow comprising a digital impression of the teeth, digital splint design, and computer-aided manufacturing of the splints. The latter is usually a milling process, however, more recently 3D printing gained popularity due to its better cost and time efficiency. It remains unknown whether 3D printed stabilization splints are inferior to milled splints regarding clinical outcomes. METHODS: This clinical trial assesses the non-inferiority of 3D printed occlusal splints compared to milled occlusal splints in a monocentric prospective randomized single-blinded crossover trial with two cohorts. One cohort includes 20 participants with bruxism, the other 20 participants with pain-related TMD, i.e., myalgia, myofascial pain, or arthralgia of the jaw muscles/the temporomandibular joint(s) diagnosed according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Michigan-type stabilization splints are fabricated in a digital workflow by milling or 3D printing using CE-marked materials within their intended purpose. The participants wear a milled and a 3D printed splint in a randomized order for 3 months each, with follow-up visits after 2 weeks and 3 months. Investigated outcome parameters are oral health-related quality of life (OHRQoL) evaluated by the Oral Health Impact Profile (OHIP-G14), participant satisfaction as rated on a visual analog scale, therapeutic efficacy, and technical result of the splints. In this context, therapeutic efficacy means antagonist wear and-in the TMD group-reduction of pain/disability assessed by the Graded Chronic Pain Scale (GCPS v2.0) and clinical assessment following the DC/TMD standard, while technical outcome measures splint fit, wear and fracture rate. DISCUSSION: The trial will provide important information on the clinical outcome of 3D printed stabilization splints in comparison to milled splints and will, therefore, enable an evidence-based decision in favor of or against a manufacturing process. This, in turn, will guarantee for a maximum of the patient's OHRQoL during splint therapy, therapeutic efficacy, and longevity of the splints. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00033904. Registered on March 15, 2024.
Asunto(s)
Bruxismo , Estudios Cruzados , Ferulas Oclusales , Impresión Tridimensional , Trastornos de la Articulación Temporomandibular , Humanos , Trastornos de la Articulación Temporomandibular/terapia , Trastornos de la Articulación Temporomandibular/diagnóstico , Método Simple Ciego , Estudios Prospectivos , Resultado del Tratamiento , Bruxismo/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios de Equivalencia como Asunto , Dimensión del Dolor , AdultoRESUMEN
BACKGROUND: One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. METHODS: This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. DISCUSSION: In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .
Asunto(s)
Embolización Terapéutica , Estudios de Equivalencia como Asunto , Síntomas del Sistema Urinario Inferior , Próstata , Hiperplasia Prostática , Humanos , Masculino , Hiperplasia Prostática/complicaciones , Hiperplasia Prostática/terapia , Embolización Terapéutica/métodos , Embolización Terapéutica/efectos adversos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/terapia , Síntomas del Sistema Urinario Inferior/diagnóstico , Resultado del Tratamiento , Próstata/irrigación sanguínea , Factores de Tiempo , Microondas/uso terapéutico , Microondas/efectos adversos , Resección Transuretral de la Próstata , Índice de Severidad de la Enfermedad , Hipertermia Inducida/métodos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , AncianoRESUMEN
BACKGROUND: The reporting of randomised controlled non-inferiority (NI) drug trials is poor with less than 50% of published trials reporting a justification of the NI margin. This is despite the introduction of the Consolidated Standards of Reporting Trials (CONSORT) extension on reporting of NI and equivalence in randomised trials. It is critical to set the appropriate NI margin as this choice dictates the conclusions of the trial. Methods to estimate the margin are heterogeneous but generally based on clinical judgement and statistical reasoning, and hence tailored to each clinical situation. Yet an appraisal of NI in clinical trials has not been undertaken. Therefore the aim of this systematic review is to assess the reporting and methodological quality of defining the NI margin. Surgical NI trials have been chosen as our prototype to assess this. METHODS: We will conduct a systematic review of published randomised controlled trials in abdominal surgery that use an NI design. Key eligibility criteria will be: surgical intervention in at least one trial arm; adult patients and a sample size of 100 or more. Ovid MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials will be searched from inception until the date of the search. Identified studies will be assessed for reporting according to the CONSORT recommendations. The outcomes are the description of the methods for defining the NI margin, and the robustness of the NI margin estimation. The latter will be based on simulations using alternative assumptions for model parameters. The results of the simulation will be compared with the trial authors' conclusions. ANTICIPATED RESULTS: The review will describe and appraise the design and reporting of surgical NI trials including shortcomings thereof and allow a comparison with pharmaceutical trials. These findings will inform researchers on the appropriate design and pitfalls when conducting surgical randomised controlled trials with an NI design and promote thorough and standardised reporting of study findings. ETHICS AND DISSEMINATION: Ethical approval is not required and any changes to the protocol will be communicated via the registration platform. The final manuscript will be submitted to a journal for publication and the findings will be disseminated through conference presentations to inform researchers and the public.
Asunto(s)
Estudios de Equivalencia como Asunto , Proyectos de Investigación , Humanos , Abdomen/cirugía , Proyectos de Investigación/normas , Revisiones Sistemáticas como AsuntoRESUMEN
The FICUS trial is a cluster-randomized superiority trial to determine the effectiveness of a nurse-led, interprofessional family support intervention (FSI) on the quality of care, family management and individual mental health of family members of critically ill patients, compared to usual care. This paper describes the statistical analysis plan of the FICUS trial. The primary outcome is quality of family care, assessed by the Family Satisfaction in ICU Questionnaire (FS-ICU-24R) at patient discharge from the ICU. Several secondary outcomes are additionally assessed 3, 6, and 12 months thereafter. Sixteen clusters (ICUs) were randomly assigned 1:1 to FSI or usual care using minimization (8 per treatment). The target sample size is 56 patients per cluster (896 in total). Recruitment has been completed in January 2024. The follow-up of the last participant will be completed in early 2025. The primary and secondary outcomes will be analyzed by linear mixed-effects models (LMM). The main model for the primary outcome will include a random intercept per cluster with treatment (FSI vs. usual care) as the only explanatory variable due to the relatively small number of clusters. In addition, covariate-adjusted analyses will be conducted, including two cluster-level characteristics used in the minimization as well as participant-level characteristics. Moreover, a number of subgroup analyses by cluster- and participant-level characteristics are pre-specified.Trial registration ClinicalTrials.gov NCT05280691 . Registered on February 20, 2022.
Asunto(s)
Unidades de Cuidados Intensivos , Humanos , Familia , Salud Mental , Interpretación Estadística de Datos , Estudios Multicéntricos como Asunto , Enfermedad Crítica , Factores de Tiempo , Ensayos Clínicos Controlados Aleatorios como Asunto , Cuidados Críticos/métodos , Calidad de la Atención de Salud , Apoyo Social , Estudios de Equivalencia como Asunto , Relaciones Profesional-Familia , Apoyo FamiliarRESUMEN
BACKGROUND: Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts. METHODS: The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator's discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs. DISCUSSION: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.
Asunto(s)
Drenaje , Endosonografía , Estudios Multicéntricos como Asunto , Seudoquiste Pancreático , Plásticos , Stents , Humanos , Seudoquiste Pancreático/terapia , Seudoquiste Pancreático/diagnóstico por imagen , Seudoquiste Pancreático/cirugía , Drenaje/instrumentación , Drenaje/métodos , Drenaje/efectos adversos , Endosonografía/métodos , Resultado del Tratamiento , Estudios de Equivalencia como Asunto , Metales , Japón , Ultrasonografía Intervencional , Masculino , AdultoRESUMEN
BACKGROUND: Currently, non- or minimally displaced distal radius fractures are treated by 3 to 5 weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that 1 week of immobilisation might be safe; however, no level 1 evidence is available. This trial aims to compare 1 week of brace immobilisation with 3 weeks of cast immobilisation in patients with distal radius fractures that do not need reduction. METHODS: The aim of this trial is to evaluate the non-inferiority of 1 week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A two-armed single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18 and 50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with 1 week of brace immobilisation, and the control group with 3 weeks of cast immobilisation. Primary outcome is the patient-reported outcome measured by the Patient-Related Wrist Evaluation score (PRWE) at 6 months. Secondary outcomes are patient-reported outcome measured by the Quick Disabilities of the Arm, Shoulder and Hand score at 6 weeks and 6 months, PRWE at 6 weeks, range of motion, patient-reported pain score measured by VAS score, radiological outcome (dorsal/volar tilt, radial height, ulnar variance, presence of intra-articular step off), complications and cost-effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire. DISCUSSION: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level 1 evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients. TRIAL REGISTRATION: ABR 81638 | NL81638.029.22 | www.toetsingonline.nl . 18th of October 2023.
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Fijación de Fractura , Fracturas del Radio , Fracturas de la Muñeca , Adolescente , Adulto , Humanos , Persona de Mediana Edad , Adulto Joven , Tirantes , Moldes Quirúrgicos , Análisis Costo-Beneficio , Estudios de Equivalencia como Asunto , Fijación de Fractura/métodos , Inmovilización/métodos , Estudios Multicéntricos como Asunto , Medición de Resultados Informados por el Paciente , Fracturas del Radio/terapia , Rango del Movimiento Articular , Recuperación de la Función , Método Simple Ciego , Factores de Tiempo , Resultado del Tratamiento , Fracturas de la Muñeca/terapia , Estudios de Evaluación como AsuntoRESUMEN
INTRODUCTION: Treating older adults with chemotherapy remains a challenge, given their under-representation in clinical trials and the lack of robust treatment guidelines for this population. Moreover, older patients, especially those with frailty, have an increased risk of developing chemotherapy-related toxicity, resulting in a decreased quality of life (QoL), increased hospitalisations and high healthcare costs. Phase II trials have suggested that upfront dose reduction of chemotherapy can reduce toxicity rates while maintaining efficacy, leading to fewer treatment discontinuations and an improved QoL. The DOSAGE aims to show that upfront dose-reduced chemotherapy in older patients with metastatic colorectal cancer is non-inferior to full-dose treatment in terms of progression-free survival (PFS), with adaption of the treatment plan (monotherapy or doublet chemotherapy) based on expected risk of treatment toxicity. METHODS AND ANALYSIS: The DOSAGE study is an investigator-initiated phase III, open-label, non-inferiority, randomised controlled trial in patients aged≥70 years with metastatic colorectal cancer eligible for palliative chemotherapy. Based on toxicity risk, assessed using the Geriatric 8 (G8) tool, patients will be stratified to either doublet chemotherapy (fluoropyrimidine with oxaliplatin) or fluoropyrimidine monotherapy. Patients classified as low risk will be randomised between a fluoropyrimidine plus oxaliplatin in either full-dose or with an upfront dose reduction of 25%. Patients classified as high risk will be randomised between fluoropyrimidine monotherapy in either full-dose or with an upfront dose reduction. In the dose-reduced arm, dose escalation after two cycles is allowed. The primary outcome is PFS. Secondary endpoints include grade≥3 toxicity, QoL, physical functioning, number of treatment cycles, dose reductions, hospital admissions, overall survival, cumulative received dosage and cost-effectiveness. Considering a median PFS of 8 months and non-inferiority margin of 8 weeks, we shall include 587 patients. The study will be enrolled in 36 Dutch Hospitals, with enrolment scheduled to start in July 2024. This study will provide new evidence regarding the effect of dose-reduced chemotherapy on survival and treatment outcomes, as well as the use of the G8 to choose between doublet chemotherapy or monotherapy. Results will contribute to a more individualised approach in older patients with metastatic colorectal cancer, potentially leading to improved QoL while maintaining survival benefits. ETHICS AND DISSEMINATION: This trial has received ethical approval by the ethical committee Leiden Den Haag Delft (P24.018) and will be approved by the Institutional Ethical Committee of the participating institutions. The results will be disseminated in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT06275958.
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Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Colorrectales , Calidad de Vida , Humanos , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Ensayos Clínicos Fase III como Asunto , Estudios de Equivalencia como Asunto , Supervivencia sin Progresión , Ensayos Clínicos Controlados Aleatorios como Asunto , Oxaliplatino/administración & dosificación , Oxaliplatino/uso terapéutico , Reducción Gradual de Medicamentos/métodosRESUMEN
INTRODUCTION: Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence. METHODS AND ANALYSIS: This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18-80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment. ETHICS AND DISSEMINATION: The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication. TRIAL REGISTRATION NUMBER: Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.
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Procedimientos Endovasculares , Terapia por Láser , Vena Safena , Insuficiencia Venosa , Humanos , Vena Safena/cirugía , Insuficiencia Venosa/cirugía , Terapia por Láser/métodos , Terapia por Láser/efectos adversos , Procedimientos Endovasculares/métodos , Estudios de Equivalencia como Asunto , Resultado del Tratamiento , Estudios Multicéntricos como Asunto , Femenino , Adulto , Escleroterapia/métodos , Soluciones Esclerosantes/uso terapéutico , Soluciones Esclerosantes/administración & dosificación , MasculinoRESUMEN
BACKGROUND: Osteoarthritis (OA) contributes increasingly to disability worldwide. There is ample high-quality research on the treatment of knee and hip OA, whereas research on surgical and non-surgical treatment in hand OA is sparse. Limited evidence suggests that education and exercise may improve pain, function, stiffness, and grip strength in hand OA. The established surgical options in hand OA have disadvantages. Prostheses preserve motion but have a high complication rate, whereas fusions decrease function due to limited movement. There is an unmet need for high-quality research on treatment options for hand OA and a need for the development of effective and safe movement-sparing therapies. This study aims to compare the effects of a motion-preserving surgical treatment (denervation of the proximal interphalangeal (PIP) joint) with a patient education and exercise program on patient-reported outcomes and objective function in painful PIP OA. METHODS: In this parallel-group, two-armed, randomized, controlled superiority trial (RCT), 90 participants are assigned to surgical PIP joint denervation or education and exercise. Pain on load 1 year after intervention is the primary outcome measure. Secondary outcome measures include pain at rest, Patient-Rated Wrist and Hand Evaluation (PRWHE), HQ8 score, EQ5D-5L, objective physical function, complications, two-point discrimination, Mini Sollerman, consumption of analgesics, and the need for further surgery. Assessments are performed at baseline, 3 and 6 months, and 1 year after intervention. DISCUSSION: There are no previous RCTs comparing surgical and non-surgical treatment in PIP OA. If patient education plus exercise or PIP denervation improve function, these treatments could be implemented as first-line treatment options in PIP OA. However, if denervation does not achieve better results than non-surgical treatment, it is not justified to use in PIP OA. TRIAL REGISTRATION: Prospectively registered in ClinicalTrials.gov (NCT05980793) on 8 August 2023. URL https://classic. CLINICALTRIALS: gov/ct2/show/NCT05980793 .