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Actively Recruiting

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had successful endoscopic removal of common bile duct stones. The study focuses on a combined outcome of death, major postoperative complications, or recurrent biliary disease within one year after randomization. The trial is designed as a randomized study involving elderly patients with specific age and health criteria. Participants are randomly assigned to either the laparoscopic cholecystectomy group or the wait-and-see group in equal numbers. The cholecystectomy procedure is performed during the same hospital stay or within two weeks after randomization. The study includes one planned interim safety analysis after 100 patients have been randomized, with the trial possibly ending early if significant differences in outcomes are detected between the two groups. During the study, researchers will monitor participants for death, major complications, or recurrent biliary events from the time of randomization up to one year. Safety and efficacy are carefully assessed to determine if the wait-and-see strategy is not worse than surgery. Participants' health status and outcomes will be tracked throughout the year following their enrollment in the trial.

Age: 75Years +All GendersPhase Not Applicable
12 locations
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Actively Recruiting

Researchers are comparing two surgical treatments, proximal row carpectomy (PRC) and four-corner fusion (FCA), for patients with a specific type of wrist osteoarthritis called SLAC/SNAC II-III. This study is a double-blinded randomized controlled trial where neither patients nor assessors know which surgery was performed until 12 months after treatment. The goal is to evaluate and compare the outcomes of these procedures in adults aged 18 to 75 who have had symptoms for more than three months. Participants are randomly assigned to receive either PRC, which involves removing the proximal carpal row bones (scaphoid, lunate, and triquetrum), or FCA, which includes excision of the scaphoid and fusion of four wrist bones using screws or a dorsal plate. The study is conducted across multiple centers and follows a strict schedule of follow-up visits to monitor progress and collect data. Before surgery, baseline information is gathered, followed by follow-up visits at 2 and 6 weeks, then 3, 6, and 12 months after the procedure. Additional follow-ups occur at 5 and 10 years to assess long-term outcomes. The main measure of success is the Patient-Rated Wrist Evaluation at 12 months. All visits include clinical assessments, and the treatment allocation is only revealed after the 12-month evaluation to maintain blinding throughout the early study period.

Age: 18Years - 75YearsAll GendersPhase Not Applicable
5 locations
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