5 Clinical Trials for Various Conditions
The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.
The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time. Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time
Hysteroscopic surgery is widely used for the treatment of gynecological diseases, such as septum, synechiae, polyp and intrauterine fibroids. The complication rate is estimated as 0.22% and includes uterine perforation, massive bleeding, and fluid overload. Operative hysteroscopy intravascular absorption (OHIA) syndrome refers to fluid overload complications from operative hysteroscopies and is considered a major complication. Report describing the clinical association between irrigation fluid temperature to intravasation rate itself or the risk of fluid overload are limited mainly to theoretical models. Due to the aforementioned, we aim to evaluated the role of temperature on absorption of the irrigation solution in hysteroscopic surgery.
Safety during operative hysteroscopy requires a fluid management system to assist in gauging patient fluid absorption of media used for visualizing the uterine cavity. Serious patient complications, including hyponatremia (low serum sodium), heart failure, and pulmonary and cerebral edema, can result from over absorption of this distending medium. Failure of surgical drapes to collect unabsorbed fluid causes inaccurate determination of the hysteroscopic fluid deficit (HD) thus preventing proper risk evaluation for patient fluid overload, could prompt premature procedure terminatio, and result in hazards for the OR team. Specific Aims: 1. To perform a comparative trial of the "Total Capture" hysteroscopy drape (TCD) versus the standard drape during patient surgeries to document improved, real-time determination of patient fluid absorption. Pilot testing of a prototype design of the "Total Capture drape" versus the conventional hysteroscopy drape indicated remarkable improvement in fluid capture and accurate fluid deficit determination in a plastic pelvic model experiment. 2. To evaluate the clinical usefulness of the TCD compared to the Standard drape for hysteroscopy with the standardized metrics of: 1) the Technology Acceptance Model, and 2) The System Usability Scale. These metrics will allow us to quantitate clinical usefulness and usability of both the operating surgeons and operating room staff. The investigators hypothesize the "Total Capture" Drape design provides an accurate recorded hysteroscopic fluid deficit in real-time so that patient safety and surgical parameters are optimized. The simple design of the TCD would add a very significant improvement for patient safety and care with minimal cost for the estimated 200,000 hysteroscopies performed per year in the U.S.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.