Clinical trials

The GLUBARI trial is a prospective, randomized, single-center clinical study comparing two bariatric surgical procedures in adults with morbid obesity: Single Anastomosis Sleeve Ileal Bypass (SASI) and Roux-en-Y Gastric Bypass (RYGB). The main objective is to compare glycemic variability between the two procedures using continuous glucose monitoring. Participants will undergo continuous glucose monitoring for 7 days before surgery and again at 6 and 12 months after surgery. Secondary outcomes include hypoglycemic events, weight loss, resolution of obesity-related comorbidities, postoperative complications, gastroesophageal reflux, nutritional deficiencies, and quality of life. A total of 68 participants will be randomized in a 1:1 ratio to SASI or RYGB and followed for 12 months after surgery.

The goal of this clinical trial is to learn whether the ClearPetra ureteral access sheath (Coloplast) is more effective than the Navigator ureteral access sheath (Boston Scientific) in treating intrarenal kidney stones of 1-3 cm in adult patients undergoing flexible ureteroscopy (RIRS). The main questions it aims to answer are: Does ClearPetra achieve a higher stone-free rate at 1 month post-intervention compared to Navigator, as assessed by non-contrast abdominal-pelvic CT scan? Does ClearPetra reduce total surgical time compared to Navigator? Does ClearPetra lower the retreatment rate at 3 months compared to Navigator? Does ClearPetra present a rate of clinically significant complications (Clavien-Dindo ≥ II) that is lower than or similar to Navigator? Researchers will compare flexible ureteroscopy using the ClearPetra vacuum-assisted flexible ureteral access sheath to flexible ureteroscopy using the Navigator standard rigid ureteral access sheath, to see if ClearPetra leads to higher stone clearance rates while maintaining a comparable safety profile. Participants will: Undergo flexible ureteroscopy (RIRS) using one of two randomly assigned ureteral access sheaths (ClearPetra or Navigator), determined by computer-generated randomization immediately before surgery Have a non-contrast abdominal-pelvic CT scan at 1 month post-intervention to assess stone-free status Have a non-contrast abdominal-pelvic CT scan at 3 months post-intervention to evaluate residual fragments and the need for retreatment Attend follow-up visits at 1 month and 3 months post-surgery for clinical assessment and complication recording The study will be conducted at the Urology Department of Hospital Universitario Virgen del Rocío (Seville, Spain), a tertiary reference centre. A total of 156 patients will be randomized in a 1:1 ratio (78 per group), with pre-defined subgroup analyses stratified by stone size (1-2 cm vs. \>2 cm). The outcome assessor evaluating CT images for stone-free rate will be blinded to treatment allocation (single-blind).

Background: Home-based telerehabilitation (TR) has demonstrated benefits comparable to conventional rehabilitation in patients with chronic obstructive pulmonary disease, asthma, and pulmonary fibrosis. However, TR has not been thoroughly investigated in patients with bronchiectasis, despite evidence suggesting improvements in exercise capacity and quality of life. Aims: To evaluate the effects of TR on functional capacity, quality of life, and inflammatory biomarkers, as well as its safety in patients with bronchiectasis. Study design: Single-center randomized controlled trial with a parallel-group design. Methods: Patients diagnosed with bronchiectasis will be recruited from the Surgical Medical Unit for Respiratory Diseases at Virgen del Rocío University Hospital. Participants will be randomly assigned to one of two groups: a control group receiving usual care, and a TR group undergoing supervised physical training for 12 weeks, three times per week. Outcome measures will include the 6-minute walk test, quality-of-life questionnaires, pulmonary function tests, symptom assessment, and adverse event recording, as well as sputum microbiology and analysis of inflammatory biomarkers. Assessments will be conducted at baseline and at the end of the intervention. Expected results: A 12-week TR program is expected to significantly improve exercise capacity and quality of life in the intervention group. Additionally, this study may contribute to the development of future clinical guidelines regarding the use of TR in patients with bronchiectasis.

CLINICAL TRIAL ON THE EFFECT OF SUPERVISED PHYSICAL EXERCISE AFTER BARIATRIC SURGERY ON MUSCLE MASS AND BONE DENSITY (OBEFIT STUDY)

Introduction: Diabetes mellitus (DM) is a group of disorders characterized by chronic hyperglycemia due to issues with insulin production or function. Globally, the incidence is about 15 cases per 100,000 people, with a prevalence of 9.5%. In Spain, the highest prevalence rates are in the Canary Islands, Murcia, and Castilla y León. DM management includes a balanced diet, exercise, medication, and therapeutic education. Nurse-led programs improve patient outcomes, and mobile apps like Social Diabetes and MySugar help calculate insulin dosages based on diet and other factors. Methodology: The study will take place at the Hospital Universitario Virgen del Rocío in Seville, Spain. Participants will be selected based on eligibility criteria, including being over 18, having diabetes under basal-bolus treatment, and being able to use a mobile phone. Exclusion criteria include cognitive impairment and severe illnesses. The intervention includes a structured education program led by nurses using mobile apps, with 3 group sessions and one individual session at 6 months. The primary outcome is glycemic control, and secondary outcomes include self-efficacy and knowledge levels. The study requires 52 participants, with data collected by nurse educators and analyzed using SPSS. Ethics approval and informed consent will be obtained. The authors declare no conflicts of interest.