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Found 2 Actively Recruiting clinical trials
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 common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.
Actively Recruiting
Researchers are comparing two surgical treatments for wrist osteoarthritis called proximal row carpectomy PRC and four-corner fusion FCA in patients with SLAC or SNAC type II-III osteoarthritis. This double-blinded randomized controlled study aims to evaluate which procedure leads to better wrist function and patient outcomes. Patients with confirmed wrist osteoarthritis will be randomly assigned to one of these two treatments and neither the patients nor assessors will know the treatment allocation until 12 months after surgery. Participants will undergo either PRC, which involves removing the proximal carpal row including the scaphoid, lunate, and triquetrum bones, or FCA, which includes scaphoid excision and fusion of the four remaining wrist bones using screws or plates. The study includes baseline assessments before surgery and follow-up visits at 2 and 6 weeks, then at 3, 6, 12 months, and long-term follow-ups at 5 and 10 years post-intervention. The treatment assignment will be revealed after the 12-month visit. Throughout the study, participants will be evaluated on wrist function using the Patient-Rated Wrist Evaluation at 12 months, along with other measures such as pain levels, grip strength, wrist range of motion, complications, quality of life, and cost-effectiveness. Follow-up visits include clinical assessments and questionnaires to monitor progress and safety. The total participation duration can extend up to 10 years with regular check-ins to assess long-term outcomes.