Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761224
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-01
First Post:
2021-02-08
Brief Title:
Impact of Intraoperative Instillation of Normothermal Saline on the Prevention of Intraoperative Hypothermia and Perioperative Morbidity of Prostatic Enucleation With Holmium Laser
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THERMHOLEP
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 17C the temperature of the instilled solution is therefore much lower than the average body temperature of the patient 37C 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 36C is 535 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 patients body mass the volume of fluids instilled and the type and duration of the operation
In spite of the usual procedures of warming by heating blanket the prevalence of hypothermia defined as a body temperature 36C is 535 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 patients body mass the volume of fluids instilled and the type and duration of the operation
Detailed Description:
Even moderate hypothermia body temperature between 34-36C 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 05C 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 - 074C versus -171C p 005 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 41C in the induction room would increase the intraoperative temperature by 02C 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
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 05C 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 - 074C versus -171C p 005 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 41C in the induction room would increase the intraoperative temperature by 02C 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None