Impact of Anesthesia-related Enhanced Recovery After Surgery Components on Mortality After Pancreaticoduodenectomy
- Conditions
- MortalityEnhanced Recovery After Surgery
- Interventions
- Procedure: Enhanced Recovery After Surgery protocol
- Registration Number
- NCT06256133
- Lead Sponsor
- Asan Medical Center
- 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 (e.g., preoperative carbohydrate loading) or the highly demanding nature of the procedures, which require significant human resources, specialized equipment, and time (e.g., 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ANS-Surg-ERAS group Enhanced Recovery After Surgery protocol fully implementing ERAS pathway including anesthesiology-related components
- Primary Outcome Measures
Name Time Method Short- and long-term mortality 180days and 2years (March 2015 to February 2022) The short- (180 days) and long-term (2 years) mortality rates among the three groups
- Secondary Outcome Measures
Name Time Method Length of stay Postoperative, through study completion (March 2015 to February 2022) the number of days from the date of surgery to the date of discharge
Re-operation rate Within 30days after surgery (March 2015 to February 2022) Re-operation rate
Inflammatory parameters On the day before surgery and postoperative day 7 ((March 2015 to February 2022) neutrophil-lymphocyte ratio (NLR) and the C-reactive protein (CRP) to albumin ratio (CAR)
Weight change Pre- and Postoperative(postoperative days 30 and 60) (March 2015 to February 2022) comparing the largest difference between baseline body weight before surgery and weight on postoperative days 30 and 60.
Re-admission rate Within 30days after surgery (March 2015 to February 2022) Re-admission rate
ERAS protocol adherence Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022) Adherance rate of included ERAS protocol components
Morbidity rate Within 3 months after surgery (March 2015 to February 2022) Postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), and postpancreatic hemorrhage (PPH), pulmonary complication, acute kidney injury
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of