4 Clinical Trials for Various Conditions
The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate surgery). This medication has been shown to decrease blood loss during this type of surgery, but the implications for bleeding following surgery are unclear. Any impact on postoperative bleeding will be assessed over the first 7 days following surgery leading up to the first scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of their bleeding. The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each day after surgery. The secondary outcomes include the the frequency with which the otolaryngology resident service is requested to evaluate patients in the recovery unit for postoperative bleeding concerns and the frequency of interventions such as application of hemostatic materials, packing, cautery, and/or return to the operating room.
Obstructive sleep apnea occurs in 2-4% of middle age adults and results in significant morbidity and mortality. The first line therapy is provision of continuous positive airway pressure (CPAP) via a nasal mask chronically. Nasal resistance related to nasal turbinate enlargement may compromise CPAP treatment. This randomized double-blind sham-placebo-controlled trial tests the hypothesis that nasal turbinate reduction improves the nasal passage, CPAP use, and sleep apnea quality of life in newly diagnosed sleep apnea patients who are recommended CPAP therapy.
Turbinates are large structures in the nasal airway that help the nose to clean and humidify the air we breathe. Inferior turbinates can swell up and block the breathing passage, making it hard to breath. To address this, turbinate size must be reduced. This study looks at two common procedures for turbinate reduction: 1. Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior (lower) turbinate that releases thermal energy, which significantly reduces its size. This can be done under local anesthesia at the doctor's office. 2. Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a piece off the turbinate, which also reduces its size. While both procedures improve nasal obstruction, no study has directly compared which is more effective. Eighty patients being treated for septal deformity and turbinate hypertrophy will be randomly chosen for either PRIT or RFA treatment. They will fill out a simple, five question survey that measures how they view their nasal blockage 4 times in one year. We believe that since PRIT permanently removes a part of the turbinate, PRIT patients will report more improvement than RFA patients one year later. We believe that complications (measured by the doctor) will be the same for both treatments.
The primary goal of this post-marketing surveillance study is to assess whether surgical turbinate reduction performed using a Coblation® device is associated with reduced nasal obstruction symptoms.