Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256133
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2024-01-14
Brief Title:
Impact of Anesthesia-related Enhanced Recovery After Surgery Components on Mortality After Pancreaticoduodenectomy
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Impact of Anesthesia-related Enhanced Recovery After Surgery Components on Mortality After Pancreaticoduodenectomy
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
Pancreaticoduodenectomy PD one of the most complex and invasive abdominal surgeries is associated with long length of stay LOS and high morbidity and mortality rates Enhanced Recovery After Surgery ERAS is gaining popularity because it reduces surgical stress and promotes physiological stability through standardized perioperative care thereby improving the recovery process and outcomes after surgery
ERAS is a comprehensive approach to perioperative care that involves the collaboration of multiple departments Within the ERAS program components primarily implemented by the anesthesiology department include preoperative carbohydrate loading maintenance of near-zero fluid balance and multimodal analgesic management such as midthoracic epidural block However they may be underutilized for several reasons such as deviation from conventional methods eg preoperative carbohydrate loading or the highly demanding nature of the procedures which require significant human resources specialized equipment and time eg thoracic epidural or transverse abdominis block
Several randomized trials involving patients undergoing PD have reported that the implementation of ERAS has provided high-level evidence on a safer and quicker recovery with decreased morbidity rates and shorter LOS than traditional care Furthermore a recent study on colorectal surgery reported that the ERAS program may improve not only short-term but also long-term oncological outcomes However there is a paucity of research investigating the effects of ERAS on mortality after PD Furthermore the impact of anesthesiology-related components within the ERAS pathway has not been extensively studied
A previously published randomized controlled trial from our institution showed that the outcomes after applying pre- and postoperative ERAS protocols without anesthesiology-related components Surg-ERAS were comparable to those of the conventional protocol This study aimed to compare the short- and long-term mortality rates among patients undergoing PD by examining the same cohort from a previous study including the conventional Non-ERAS and Surg-ERAS groups in addition to anesthesia fully implementing ERAS programs ANS-Surg-ERAS group Moreover LOS inflammation parameters such as neutrophil to lymphocyte ratio NLR and C-reactive protein to albumin ratio CAR morbidity rate reoperation rate and readmission rate were compared among the three groups
ERAS is a comprehensive approach to perioperative care that involves the collaboration of multiple departments Within the ERAS program components primarily implemented by the anesthesiology department include preoperative carbohydrate loading maintenance of near-zero fluid balance and multimodal analgesic management such as midthoracic epidural block However they may be underutilized for several reasons such as deviation from conventional methods eg preoperative carbohydrate loading or the highly demanding nature of the procedures which require significant human resources specialized equipment and time eg thoracic epidural or transverse abdominis block
Several randomized trials involving patients undergoing PD have reported that the implementation of ERAS has provided high-level evidence on a safer and quicker recovery with decreased morbidity rates and shorter LOS than traditional care Furthermore a recent study on colorectal surgery reported that the ERAS program may improve not only short-term but also long-term oncological outcomes However there is a paucity of research investigating the effects of ERAS on mortality after PD Furthermore the impact of anesthesiology-related components within the ERAS pathway has not been extensively studied
A previously published randomized controlled trial from our institution showed that the outcomes after applying pre- and postoperative ERAS protocols without anesthesiology-related components Surg-ERAS were comparable to those of the conventional protocol This study aimed to compare the short- and long-term mortality rates among patients undergoing PD by examining the same cohort from a previous study including the conventional Non-ERAS and Surg-ERAS groups in addition to anesthesia fully implementing ERAS programs ANS-Surg-ERAS group Moreover LOS inflammation parameters such as neutrophil to lymphocyte ratio NLR and C-reactive protein to albumin ratio CAR morbidity rate reoperation rate and readmission rate were compared among the three groups
Detailed Description:
None
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