Prostatic Hypertrophy Clinical Trial
— THERMHOLEPOfficial title:
Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser: a Prospective Randomized Controlled Study
Verified date | July 2023 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | September 30, 2024 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male patient whose age is = 18 years old - Patient eligible for holmium laser prostate enucleation - Patient affiliated to a social security system - Francophone patient - Patient who has given free, informed and written consent Exclusion Criteria: - Patient already included in a Type 1 Intervention Research Protocol (RIPH1) - Patient under guardianship or curatorship - Patient deprived of liberty - Patient under legal protection |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint-Joseph | Paris |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effectiveness of warming patients by intravesical instillation of warmed intravesical fluid using the Fluido® Irrigation device, by assessing the rate of hypothermic patients on arrival in post-procedural follow-up care. | Rate of hypothermic patients (< 36°C) on arrival in post-procedural follow-up care. | Day 1 | |
Secondary | Evaluate the variation of body temperature intraoperatively | Temperature difference between entry into the operating room and arrival in post-operative follow-up care (in °C) | Day 1 | |
Secondary | Duration of general anesthesia | Time between anesthetic induction and extubation (in min) | Day 1 | |
Secondary | Complications rate within 30 days postoperatively | Complications according to Clavien- Dindo (%) | Day 30 | |
Secondary | Rate of complications in the 30 days postoperatively according to preoperative prostate weight (< 100g, = 100g but = 200g, > 200g) | Complications according to Clavien- Dindo (%) | Day 30 | |
Secondary | Rate of serious complications within 30 days postoperatively | Complications Clavien-Dindo = III (%) | Day 30 | |
Secondary | ECG modifications induced by hypothermia | Rate of ECG changes in post-procedural follow-up care (%) | Day 30 | |
Secondary | Serum troponin modifications induced by hypothermia | Change in serum troponin between Day 0 and Day 1 (ng/L) | Day 30 | |
Secondary | Hb loss > 2g/dL postoperatively | Day 30 | ||
Secondary | Transfusion within 30 days postoperatively | Day 30 | ||
Secondary | Unblocking at the patient's bedside | Day 30 | ||
Secondary | Surgical resection for unblocking | Day 30 | ||
Secondary | Re - admission within 30 days postoperatively for macroscopic hematuria | Day 30 | ||
Secondary | Duration of bladder catheterization | Number of days of bladder catheterization | Day 1 | |
Secondary | Evaluation of the length of hospital stay | Number of days in hospital | An average of 2 days | |
Secondary | International Prostate Symptom Score (IPSS score) | 0 - 7 = mild 8 - 19 = moderate 20 - 35 = severe | 3 months | |
Secondary | International Prostate Symptom Score (IPSS score) | 0 - 7 = mild 8 - 19 = moderate 20 - 35 = severe | 12 months | |
Secondary | Functional evaluation | Quality of Life score (QoL score)
0 = very satisfied 6 = very bored |
3 months | |
Secondary | Functional evaluation | Quality of Life score (QoL score)
0 = very satisfied 6 = very bored |
12 months | |
Secondary | 5-item version of the International Index of Erectile Function ( IIEF-5) | 1 - 4 = Not interpretable 5 - 10 = Severe erectile dysfunction 11 - 15 = Moderate erectile dysfunction 16 - 20 = Mild erectile dysfunction 21 - 25 = Normal erectile function | 3 months | |
Secondary | 5-item version of the International Index of Erectile Function ( IIEF-5) | 1 - 4 = Not interpretable 5 - 10 = Severe erectile dysfunction 11 - 15 = Moderate erectile dysfunction 16 - 20 = Mild erectile dysfunction 21 - 25 = Normal erectile function | 12 months |
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