Prostatic HypertrophyTHERMHOLEPNCT04761224
Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser
A study testing Fluido® Irrigation Fluid Heater System in people with Prostatic Hypertrophy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hypertrophy
- What is being tested?
- Fluido® Irrigation Fluid Heater System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient already included in a Type 1 Intervention Research Protocol (RIPH1)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the detailed description
Even moderate hypothermia (body temperature between 34-36°C) would contribute significantly to the increase in postoperative morbidity and mortality. Indeed, it would significantly increase blood loss (16%) with an increased relative risk of transfusion (22%) by altering platelet aggregation and coagulation cascade enzyme function. It would also be responsible for an increase in the risk of infection and length of hospitalization, alteration of drug metabolism (accumulation of serum curare and delayed awakening) and a decrease in postoperative tremors, which can lead to severe cardiovascular complications (myocardial infarction, heart rhythm disorder, etc.).
Due to the instillation of hypothermic solution, perioperative hypothermia is frequent in endoscopic surgery (arthroscopy, abdominal laparoscopy, endoscopic prostate resection...), in the order of 48% to 64%. Several studies have evaluated the impact of pre- and intraoperative warming procedures. Thus, intraoperative external body heating would decrease the risk of hypothermia and its complications during RTUP. Similarly, the use of heated intravenous fluids has been shown to decrease the depth of hypothermia (+0.5°C) during endoscopic surgery and RTUP.
Several authors have examined the warming of IV bags instilled during RTUP procedures, the reference endoscopic surgery for BPH management. Pit et al. have shown a significant increase in postoperative body temperature in patients who underwent RTUP with isothermal solutions compared to the group undergoing a standard procedure (- 0.74°C versus -1.71°C, p < 0.05). These results were corroborated by the study by Singh et al. but none of these studies evaluated the impact of these measures on postoperative morbidity nor showed a statistical impact on intraoperative blood loss.
Holmium Laser Enucleation of the Prostate (HoLEP) is an endoscopic surgical technique that was first described by Gilling in New Zealand in 1998, and is indicated since 2013 as an alternative to RTUP for the management of symptomatic BPH. It requires continuous intravesical instillation of saline throughout the procedure. The complication rate in the 30 days postoperatively is 19 to 25%, and this risk increases with the duration of the surgery, which in turn is directly correlated to the volume of prostate to be enucleated.
Currently, only one study has studied the consequences of hypothermia during EPL procedures: the authors have shown that external body preheating to a temperature of 41°C, in the induction room, would increase the intraoperative temperature by + 0.2°C on average, and would therefore reduce the incidence of tremors during EPL performed under spinal anesthesia. On the other hand, the investigators did not find any study on the impact of warming of solutes during HoLEP, either on the immediate postoperative incidence in the post-operative monitoring room (SSPI) or on morbidity in the post-operative period.
This study thus consists in analyzing, in a prospective manner, the effect of warming of the solutes instilled during HoLEP on the post-operative morbidity of patients. To the investigators' knowledge, this is the first study of this type in the literature.
- Conditions
- Prostatic Hypertrophy
- Being tested
- Fluido® Irrigation Fluid Heater System
- Keywords
- normothermal solution, enucleation, hypothermia
- Medical subject headings
- Prostatic Hyperplasia, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluido® Irrigation Fluid Heater SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Fluido® Irrigation Fluid Heater System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (20)
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)
Measured: Day 1
Duration of general anesthesia
Time between anesthetic induction and extubation (in min)
Measured: Day 1
Complications rate within 30 days postoperatively
Complications according to Clavien- Dindo (%)
Measured: Day 30
Rate of complications in the 30 days postoperatively according to preoperative prostate weight (< 100g, ≥ 100g but ≤ 200g, > 200g)
Complications according to Clavien- Dindo (%)
Measured: Day 30
Rate of serious complications within 30 days postoperatively
Complications Clavien-Dindo ≥ III (%)
Measured: Day 30
ECG modifications induced by hypothermia
Rate of ECG changes in post-procedural follow-up care (%)
Measured: Day 30
Serum troponin modifications induced by hypothermia
Change in serum troponin between Day 0 and Day 1 (ng/L)
Measured: Day 30
Hb loss > 2g/dL postoperatively
Measured: Day 30
Transfusion within 30 days postoperatively
Measured: Day 30
Unblocking at the patient's bedside
Measured: Day 30
Surgical resection for unblocking
Measured: Day 30
Re - admission within 30 days postoperatively for macroscopic hematuria
Measured: Day 30
Duration of bladder catheterization
Number of days of bladder catheterization
Measured: Day 1
Evaluation of the length of hospital stay
Number of days in hospital
Measured: An average of 2 days
International Prostate Symptom Score (IPSS score)
0 - 7 = mild 8 - 19 = moderate 20 - 35 = severe
Measured: 3 months
International Prostate Symptom Score (IPSS score)
0 - 7 = mild 8 - 19 = moderate 20 - 35 = severe
Measured: 12 months
Functional evaluation
Quality of Life score (QoL score)
0 = very satisfied 6 = very bored
Measured: 3 months
Functional evaluation
Quality of Life score (QoL score)
0 = very satisfied 6 = very bored
Measured: 12 months
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
Measured: 3 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constance MICHEL, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761224
- Sponsor's protocol ID
- THERMHOLEP
- Acronym
- THERMHOLEP
- Status last verified
- Jul 2023
- First submitted
- 8 Feb 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04761224
- Acronym / sponsor ID
- THERMHOLEP / THERMHOLEP
- Conditions
- Prostatic Hypertrophy
- Keywords
- normothermal solution, enucleation, hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Even moderate hypothermia (body temperature between 34-36°C) would contribute significantly to the increase in postoperative morbidity and mortality. Indeed, it would significantly increase blood loss (16%) with an increased relative risk of transfusion (22%) by altering platelet aggregation and coagulation cascade enzyme function. It would also be responsible for an increase in the risk of infection and length of hospitalization, alteration of drug metabolism (accumulation of serum curare and delayed awakening) and a decrease in postoperative tremors, which can lead to severe cardiovascular complications (myocardial infarction, heart rhythm disorder, etc.).
Due to the instillation of hypothermic solution, perioperative hypothermia is frequent in endoscopic surgery (arthroscopy, abdominal laparoscopy, endoscopic prostate resection...), in the order of 48% to 64%. Several studies have evaluated the impact of pre- and intraoperative warming procedures. Thus, intraoperative external body heating would decrease the risk of hypothermia and its complications during RTUP. Similarly, the use of heated intravenous fluids has been shown to decrease the depth of hypothermia (+0.5°C) during endoscopic surgery and RTUP.
Several authors have examined the warming of IV bags instilled during RTUP procedures, the reference endoscopic surgery for BPH management. Pit et al. have shown a significant increase in postoperative body temperature in patients who underwent RTUP with isothermal solutions compared to the group undergoing a standard procedure (- 0.74°C versus -1.71°C, p < 0.05). These results were corroborated by the study by Singh et al. but none of these studies evaluated the impact of these measures on postoperative morbidity nor showed a statistical impact on intraoperative blood loss.
Holmium Laser Enucleation of the Prostate (HoLEP) is an endoscopic surgical technique that was first described by Gilling in New Zealand in 1998, and is indicated since 2013 as an alternative to RTUP for the management of symptomatic BPH. It requires continuous intravesical instillation of saline throughout the procedure. The complication rate in the 30 days postoperatively is 19 to 25%, and this risk increases with the duration of the surgery, which in turn is directly correlated to the volume of prostate to be enucleated.
Currently, only one study has studied the consequences of hypothermia during EPL procedures: the authors have shown that external body preheating to a temperature of 41°C, in the induction room, would increase the intraoperative temperature by + 0.2°C on average, and would therefore reduce the incidence of tremors during EPL performed under spinal anesthesia. On the other hand, the investigators did not find any study on the impact of warming of solutes during HoLEP, either on the immediate postoperative incidence in the post-operative monitoring room (SSPI) or on morbidity in the post-operative period.
This study thus consists in analyzing, in a prospective manner, the effect of warming of the solutes instilled during HoLEP on the post-operative morbidity of patients. To the investigators' knowledge, this is the first study of this type in the literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –heated blanket + unheated NaCL instillation (operating room ambient temperature: around 17°C). |
| Heated group | Experimental | Device: Fluido® Irrigation Fluid Heater Systemheating blanket + instillation of NaCl at 38-39°C by Fluido® Irrigation fluid heating system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patient already included in a Type 1 Intervention Research Protocol (RIPH1)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluido® Irrigation Fluid Heater SystemPatients 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. | Device | Heated group |
Primary outcome
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.
Time frame: Day 1
Rate of hypothermic patients (< 36°C) on arrival in post-procedural follow-up care.
20 secondary outcomes
Evaluate the variation of body temperature intraoperatively
Time frame: Day 1
Duration of general anesthesia
Time frame: Day 1
Complications rate within 30 days postoperatively
Time frame: Day 30
Rate of complications in the 30 days postoperatively according to preoperative prostate weight (< 100g, ≥ 100g but ≤ 200g, > 200g)
Time frame: Day 30
Rate of serious complications within 30 days postoperatively
Time frame: Day 30
ECG modifications induced by hypothermia
Time frame: Day 30
Serum troponin modifications induced by hypothermia
Time frame: Day 30
Hb loss > 2g/dL postoperatively
Time frame: Day 30
Transfusion within 30 days postoperatively
Time frame: Day 30
Unblocking at the patient's bedside
Time frame: Day 30
Surgical resection for unblocking
Time frame: Day 30
Re - admission within 30 days postoperatively for macroscopic hematuria
Time frame: Day 30
Duration of bladder catheterization
Time frame: Day 1
Evaluation of the length of hospital stay
Time frame: An average of 2 days
International Prostate Symptom Score (IPSS score)
Time frame: 3 months
International Prostate Symptom Score (IPSS score)
Time frame: 12 months
Functional evaluation
Time frame: 3 months
Functional evaluation
Time frame: 12 months
5-item version of the International Index of Erectile Function ( IIEF-5)
Time frame: 3 months
5-item version of the International Index of Erectile Function ( IIEF-5)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance MICHEL, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluido® Irrigation Fluid Heater System in people with Prostatic Hypertrophy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.