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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

This research evaluates two types of minimally invasive hysterectomy surgeries for women with large benign uteri, which are uteri weighing more than 280 grams. Hysterectomy is a common gynecological surgery performed via laparotomy, laparoscopy, or the vaginal route. The study aims to compare the new vaginal natural orifice transluminal endoscopic system vNOTES approach with the standard laparoscopic hysterectomy, focusing on safety and complications for large uteri, as current data on optimal approaches are limited and inconsistent. The study compares two surgical methods laparoscopic hysterectomy, performed in a standardized way with or without robotic assistance, and vNOTES hysterectomy, which uses a vaginal approach with an endoscopic system. The vNOTES method offers the advantage of combining vaginal and endoscopic surgery, potentially reducing pain, complications, and hospital stay without scarring. Each participant will undergo one of these procedures according to random assignment. Participants will be women over 18 years old with large benign uteri who agree to participate. Researchers will monitor patients for complications from surgery through six weeks post-operation, as well as any need to switch to another surgical method during the procedure. The study includes preoperative consultations and follow-up visits to assess safety and recovery. Participation is expected to last from surgery through at least six weeks of post-surgical monitoring.

Age: 18Years +FEMALEPhase Not Applicable
6 locations
E

Actively Recruiting

Crohns disease CD is a chronic inflammatory bowel disease that can severely impact patients quality of life by causing intestinal damage such as stenosis and fistulas, often leading to surgery. The goal of treatment has evolved from just clinical remission to achieving both clinical remission and healing of the intestinal lining, which reduces disease progression risks. The CALM strategy uses close monitoring of symptoms and biological markers like fecal calprotectin to guide treatment intensification and improve healing outcomes. Researchers are investigating whether adding MRI-based assessment of transmural healing to this approach can further reduce disease progression in patients receiving biotherapy. This randomized, open-label study compares two treatment strategies for adults with active Crohns disease starting biotherapy. One group follows the CALM strategy with regular clinical and biological monitoring, while the other group adds scheduled MRI evaluations to assess transmural healing. MRIs are performed at baseline, weeks 24, 52, 76, and 152 in the MRI group, with treatment intensification based on residual activity seen on imaging. Both groups receive biotherapy guided by French consensus guidelines, and patients are followed for approximately three years. Participants will be regularly monitored through clinical evaluations, fecal calprotectin tests, and MRIs as scheduled. They will keep a symptom diary recording abdominal pain and stool frequency monthly. Researchers will measure the proportion of time spent in clinical remission without corticosteroids between weeks 24 and 76 as the primary outcome. Safety and other secondary outcomes will be assessed centrally. The study will analyze data on an intention-to-treat basis and includes ongoing follow-up over nearly three years.

Age: 18Years +All GendersPhase Not Applicable
17 locations