Impact of Anesthesia-related Enhanced Recovery After Surgery Components on Mortality After Pancreaticoduodenectomy

NCT06256133 | Completed DMC

• 1 other identifier: 2022-0019
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery; Mortality

Keywords

Pancreaticoduodenectomy; Enhanced Recovery After Surgery; Mortality; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Short- and long-term mortality

  The short- (180 days) and long-term (2 years) mortality rates among the three groups

  180days and 2years (March 2015 to February 2022)

Secondary Outcomes (7)

• ERAS protocol adherence

  Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022)

• Length of stay

  Postoperative, through study completion (March 2015 to February 2022)

• Morbidity rate

  Within 3 months after surgery (March 2015 to February 2022)

• Re-operation rate

  Within 30days after surgery (March 2015 to February 2022)

• Re-admission rate

  Within 30days after surgery (March 2015 to February 2022)

Study Arms (3)

ANS-Surg-ERAS group

fully implementing ERAS pathway including anesthesiology-related components

Procedure: Enhanced Recovery After Surgery protocol

Surg-ERAS group

preoperative and postoperative ERAS protocol without anesthesiology-related components

Conventional group

non-ERAS group

Interventions

Enhanced Recovery After Surgery protocol PROCEDURE

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)

ANS-Surg-ERAS group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Department of Hepatobiliary and Pancreatic Surgery initiated the ERAS program without collaborating with the anesthesiology department. Data for 247 patients receiving conventional and Surg-ERAS were extracted from the previous trial from March 2015 to May 2017. Since then, emphasis on the multidisciplinary aspect of the ERAS program has increased, leading to the involvement of the Department of Anesthesiology. From the start of the ERAS collaboration in July 2018, clinical data, including protocol adherence and clinical outcomes, have been prospectively recorded. Subsequently, 355 patients were included and followed up for at least 2 years to assess the relationship between different ERAS bundles and mortality.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Study Officials

• Hyemee Kwon, M.D, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 13, 2024
• Study Start: March 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

KR (1)