Clinical trials

This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become "frail." This means they lose strength and are at a higher risk for health problems. The main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology. The results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use. In short, this work aims to help patients reach the day of their surgery in the best possible condition.

Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials. The objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG. This is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.

Introduction. Chronic kidney disease (CKD) affects 10%-15% of the global population and is projected to become the fifth leading cause of years of life lost by 2040. Despite the benefits of kidney transplantation (KT), access remains inequitable. In Spain, which leads the world in KT rates per million population, disparities may persist due to structural, territorial, and professional barriers. This study aims to explore the mechanisms underlying treatment deprivation and inequity in KT access using a mixed-methods approach. Methods and analysis. A transformative mixed-methods design will be implemented in four phases: (1) systematic reviews on instruments assessing treatment deprivation and inequalities in CKD and KT; (2) a multicenter quantitative study and qualitative interviews with professionals and patients; (3) a pre-experimental evaluation of a training program on KT; and (4) triangulation and translation of findings to inform national policy. The protocol adheres to GRAMMS and PRISMA guidelines. Ethics and dissemination. Approved by the Hospital del Mar Research Institute Ethics Committee (ID: XX), the study complies with EU data protection laws. Informed consent will be obtained. Findings will be disseminated via peer-reviewed publications, conferences, social media, and patient forums to support equity-focused strategies in KT.

Radiofrequency devices have been increasingly employed in liver surgery in order to achieve proper hemostasis and this use has become more evident with the implementation of minimal invasive surgery. Due to its well-known efficacy for tumor ablation (i.e. hepatocarcinoma) it use has been extended in some cases to ablate the liver surface after resection in questionable resection. Till date, despite the majority of surgeons apply an additional coagulation in doubtful margins, there is not an evidence that this maneuver really decreases the local recurrence or increases the overall survival. On the contrary, some studies have suggested that non-anatomical resections in order to spare liver parenchyma could lead to major zones of liver ischemia in the remnant liver and thus favoring recurrence. However, major liver ischemia (defined as grade 2 o more) is unlikely to be provoked by 1 cm-depth additional coagulation of the margin. The investigators previously published in a retrospective study the concept of additional margin coagulation within liver resections and narrow margins and demonstrated that the study group had significantly less local recurrence compared to the controls. Therefore, in the present study the aim is to continue this evaluation through a multicenter randomized clinical trial.

Pancreatic surgery, specifically pancreatoduodenectomy (PD), is a complex procedure often required for patients with pancreatic or other periampullary cancers. In recent years, minimally invasive techniques have become more popular, especially robotic-assisted surgery. However, there are limited studies comparing robotic surgery to traditional open surgery. This is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess complications within 90 days after surgery. This study is important because it will provide evidence on which approach is safer and more effective for patients. The study follows a \*\*prospective, randomized, and multicenter design\*\*, meaning patients are assigned to either robotic or open surgery randomly, and multiple hospitals are involved. The study will include all eligible patients undergoing planned PD surgery, either by robotic or open technique. To be included in the study, patients must meet these conditions: * Be \*\*18 years or older\*\*. * Require \*\*planned PD surgery\*\*. * Sign an \*\*informed consent form\*\*. Who Cannot Participate? Patients will \*\*not\*\* be included if they: * \*\*Refuse the procedure\*\*. * Have \*\*uncertainty about vascular involvement\*\*. * Have a severe health condition classified as \*\*ASA IV\*\* (high-risk for surgery). The main outcome measured will be the \*\*Comprehensive Complication Index (CCI), a standardized way to assess post-surgical complications. Additional factors being studied include: * \*\*Clinical outcomes\*\* during and after surgery. * \*\*Quality of life\*\* assessments. * \*\*Surgical costs\*\*. * \*\*Hospital stay duration\*\*. * \*\*Need to switch from robotic to open surgery\*\*. * \*\*Need for additional surgery (reoperations)\*\*. * \*\*Hospital readmissions\*\*. Where Is the Study Being Conducted? The study is being conducted in \*\*ten major hospitals across Spain\*\*: 1. Hospital del Mar, Barcelona 2. Hospital Balmis, Alicante 3. Hospital Vall d'Hebron, Barcelona 4. Arnau de Vilanova, Lleida 5. Joan XXIII, Tarragona 6. Hospital Sant Pau, Barcelona 7. Germans Trias i Pujol, Barcelona 8. Hospital Clínic, Barcelona 9. HM Sanchinarro, Madrid 10. Hospital Rio Hortega, Valladolid How Long Will the Study Last? The study will take \*\*two years\*\* to complete, and patients will be followed for \*\*three years\*\* after surgery to track long-term outcomes. Why Is This Study Important for Patients? For patients undergoing PD, this study will provide essential information about the risks and benefits of robotic versus open surgery. The findings will help doctors determine the best surgical approach, leading to improved safety, faster recovery, and better long-term health outcomes. If you are a patient facing this type of surgery, participating in this study could contribute to valuable medical knowledge while ensuring that you receive a carefully monitored treatment plan.

A "textbook outcome" patient is defined as one whose surgical course is uneventful, with no complications, readmissions, or mortality. There is a lack of published research regarding textbook outcomes with an acute appendicitis that are treated with an appendectomy.

TROMS (trainee reported outcome assessment): assessment of surgical training of residents in general surgery

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.