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Prostatic Hypertrophy clinical trials

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NCT ID: NCT04761224 Active, not recruiting - Clinical trials for Prostatic Hypertrophy

Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser

THERMHOLEP
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

For the treatment of benign prostatic hyperplasia (BPH), 2 types of endoscopic surgery are currently performed: transurethral prostate resection (TPR), the reference surgery, and laser prostatic enucleation (LPE). These procedures can be performed under general anesthesia, or local anesthesia, such as spinal anesthesia. The EPL or RTUP procedure requires the instillation of continuous intra-vesical fluids throughout the procedure. These 3L bags are often kept at the ambient temperature of the operating room (around 17°C): the temperature of the instilled solution is therefore much lower than the average body temperature of the patient (37°C). Thus, and by heat exchange, it often results in per and postoperative hypothermia, which is all the more frequent and profound the longer the duration of the operation. In spite of the usual procedures of warming by heating blanket, the prevalence of hypothermia, defined as a body temperature < 36°C, is 53.5% during surgical procedures. This hypothermia is all the more frequent and profound the older the patient is and the longer the duration of anesthesia. Several studies have shown that hypothermia is particularly frequent during abdomino-pelvic surgery, notably due to pathophysiological phenomena induced by anesthetic procedures. Indeed, general anesthesia, or major locoregional anesthesia, disrupts the thermoregulation center upon anesthetic induction, with alteration of peripheral vasoconstriction and tremor capacity, leading to a rapid redistribution of body heat from the center to the periphery. Through exchanges with the environment, this results in a rapid linear decrease in central body temperature that exceeds the metabolic energy produced. However, anesthetic procedures are not the only cause of hypothermic intraoperative phenomena. It has been shown that the decrease in body temperature associated with most genitourinary endoscopic procedures is multifactorial, taking into account the patient's body mass, the volume of fluids instilled, and the type and duration of the operation.