Narberth

Researchers are investigating the changes in the peritoneal membrane of children and adults undergoing peritoneal dialysis PD, focusing on early tissue and vascular changes that occur during treatment. The study aims to understand how the membrane transforms over time, leading to complications such as fibrosis, blood vessel changes, and loss of membrane function, which can cause PD to fail. This international, prospective study includes children with kidney failure and those receiving PD, as well as healthy individuals undergoing abdominal surgery for comparison. The study involves collecting peritoneal membrane biopsies during clinically required surgeries, such as catheter insertion, hernia repair, catheter exchange, and kidney transplantation. Biopsies and tissue samples are analyzed using detailed histomorphometry and protein expression to relate structural changes to PD treatment types, duration, and functional outcomes. Blood samples are taken during routine clinical care to study inflammation and cardiovascular markers. The study also includes patients after kidney transplantation to evaluate the membranes response post-PD. Participants will undergo surgery for clinical reasons where tissue samples are collected without significantly increasing surgical time or risk. Researchers will measure vessel changes in the peritoneal membrane and correlate findings with PD treatment time and other health factors. The study tracks these changes over several years, with the main outcome being the degree of blood vessel disease in the membrane after two years of PD treatment. Overall, the study may provide insights to optimize PD treatment based on individual membrane characteristics.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.