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

NCT04761224 | Unknown

• 1 other identifier: THERMHOLEP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Hypertrophy

Keywords

normothermal solution; enucleation; hypothermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Evaluate the variation of body temperature intraoperatively

  Day 1

• Duration of general anesthesia

  Day 1

• Complications rate within 30 days postoperatively

  Day 30

• Rate of complications in the 30 days postoperatively according to preoperative prostate weight (< 100g, ≥ 100g but ≤ 200g, > 200g)

  Day 30

• Rate of serious complications within 30 days postoperatively

  Day 30

Study Arms (2)

control group

NO INTERVENTION

heated blanket + unheated NaCL instillation (operating room ambient temperature: around 17°C).

Heated group

EXPERIMENTAL

heating blanket + instillation of NaCl at 38-39°C by Fluido® Irrigation fluid heating system

Device: Fluido® Irrigation Fluid Heater System

Interventions

Fluido® Irrigation Fluid Heater System DEVICE

Patients in the "Heated" group will benefit from intraoperative warming by means of NaCl bags instilled using the Fluido® Irrigation warming cassette and with the use of specific instillation tubing (SEBAC laboratory, Set URO Fluido® Irrigation): this device allows continuous and precise heating of the solution with an instillation temperature of 38-39°C.

Heated group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient already included in a Type 1 Intervention Research Protocol (RIPH1)
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Hypothermia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Constance MICHEL, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The surgeon cannot be blind to the treatment group. On the other hand, the treatment group will be masked for all the participants (doctors and nurses) in charge of collecting the judgement criteria.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

FR (1)