Asan Medical Center
Seoul, 05505, South Korea
NCT Number: NCT06256133
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.
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Notify Me20 year and older
All sexes
Observational
Seoul, 05505, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
*the previous trial: Hwang DW, Kim HJ, Lee JH, Song KB, Kim MH, Lee SK, Choi KT, Jun IG, Bang JY, Kim SC: Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial. Journal of Hepato-Biliary-Pancreatic Sciences 2019; 26:360-9
Preoperative oral carbohydrate loading, Ultrasound-assisted thoracic epidural catheter placement, Intraoperative individualized goal-directed fluid therapy, Active warming techniques, The inspired fractional concentration of oxygen was maintained, Multimodal postoperative nausea and vomiting (PONV) prevention strategies, Anesthesia was maintained using a target-controlled infusion (TCI) of propofol and remifentanil, Scheduled administration of an intravenous (IV) or oral nonsteroidal anti-inflammatory drug (NSAID) (50 mg of dexketoprofen)
Time frame: 180days and 2years (March 2015 to February 2022)
The short- (180 days) and long-term (2 years) mortality rates among the three groups
Time frame: Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022)
Adherance rate of included ERAS protocol components
Time frame: Postoperative, through study completion (March 2015 to February 2022)
the number of days from the date of surgery to the date of discharge
Time frame: 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
Time frame: Within 30days after surgery (March 2015 to February 2022)
Re-operation rate
Time frame: Within 30days after surgery (March 2015 to February 2022)
Re-admission rate
Time frame: 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)
Time frame: 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.
Asan Medical Center
Other
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