6 Clinical Trials for Various Conditions
We are performing this research to study if routine flushing is necessary to prevent obstructions of a nephrostomy tube. This study will evaluate patients that have nephrostomy tube or will have nephrostomy tubes placed as part of their standard clinical care. If you agree to participate in this stuy, you will undergo randomized assignment to either continue to routinely flush your nephrostomy tube with normal saline or not to routinely flush your nephrostomy tube with normal saline. You will be in the study for approximately 3 months if you decide to stay for the whole study.
The purpose of this study is to compare relevant clinical outcomes in patients requiring percutaneous nephrostomy for urolithiasis treatment between those who undergo an antegrade approach versus a retrograde approach and to determine which clinical characteristics predict success of lithotomy with anterograde or retrograde percutaneous nephrostomy approaches.
The investigators are trying to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compare to obtaining renal access at the time of surgery.
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.
Analgesics and sedatives administered to control distress from minimally invasive surgical procedures have limited effectiveness and serious side effects. Unabated distress not only interferes with smooth progression of the ongoing procedure, but can elicit adverse responses when patients need additional intervention. The long-term objective of this research is to provide a safe and practical behavioral method for reducing cognitive and physiologic distress associated with invasive procedures. Currently, this method should benefit at least 8 million patients annually in the US. Extrapolating the risk of intravenous conscious sedation to the number of invasive procedures performed annually, we predict that 47,000 patients will suffer serious cardiorespiratory complications and 2,600 will die. These numbers do not include effects of the psychological damage inflicted by poorly managed procedure-related stress on patients' subsequent health behavior. This application sets out to pursue three aims: 1) Prospectively determine the impact of self-hypnotic relaxation on cognitive and physiologic distress during tumor embolizations; 2) Prospectively determine the impact of self-hypnotic relaxation on distress in the postoperative period; 3) Determine the impact of intraprocedural self-hypnotic relaxation on distress during subsequent tumor embolization. We hypothesize that: 1) Self-hypnotic relaxation decreases cognitive and physiologic distress during tumor embolizations. 2) Self-hypnotic relaxation decreases cognitive and physiologic distress after tumor embolization when post-embolization ischemia is expected to induce painful stimuli and systemic distress. 3) The beneficial effect of self-hypnotic coping skills acquired during an invasive procedure carries over to the next invasive procedure. Upon completion, the efficacy and durability of procedural administration of nonpharmacologic analgesia will be known by a rigorous and practical assessment. The relative performance of self-hypnotic relaxation will be quantified compared to standard care and empathic controls in a well-characterized population of patients within the controlled and monitored environment of a busy interventional radiology practice. Results from this competing renewal will provide the next level of data needed for future study design to determine broad clinical utility in a multicenter randomized controlled trial.
This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).