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

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06256133
• Other study ID #: 2022-0019
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

• The inclusion cirteria: The participants for this study comprised patients who were enrolled in the previous trial and those who met the same recruitment criteria, except for the inclusion of the ERAS protocol.

*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

• The exclusion criteria were as follows: distant metastasis, recurred periampullary cancer, active or uncontrolled infectious disease, severe psychological or neurological disease, alcohol or drug addiction, overlapping with other clinical trials, pregnancy, uncontrolled cardiopulmonary disease, comorbidities that could affect the quality of life and nutritional status (e.g., liver cirrhosis and renal failure), a history of major abdominal surgery (e.g., gastric resection or colonic resection), the need for simultaneous adjacent organ resection (e.g., portal vein, superior mesenteric vein, transverse colon, and liver), and plan to perform minimally invasive PD.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Mortality

Intervention

Procedure:
• Enhanced Recovery After Surgery protocol
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)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ERAS protocol adherence	Adherance rate of included ERAS protocol components	Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022)
Secondary	Length of stay	the number of days from the date of surgery to the date of discharge	Postoperative, through study completion (March 2015 to February 2022)
Secondary	Morbidity rate	Postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), and postpancreatic hemorrhage (PPH), pulmonary complication, acute kidney injury	Within 3 months after surgery (March 2015 to February 2022)
Secondary	Re-operation rate	Re-operation rate	Within 30days after surgery (March 2015 to February 2022)
Secondary	Re-admission rate	Re-admission rate	Within 30days after surgery (March 2015 to February 2022)
Secondary	Inflammatory parameters	neutrophil-lymphocyte ratio (NLR) and the C-reactive protein (CRP) to albumin ratio (CAR)	On the day before surgery and postoperative day 7 ((March 2015 to February 2022)
Secondary	Weight change	comparing the largest difference between baseline body weight before surgery and weight on postoperative days 30 and 60.	Pre- and Postoperative(postoperative days 30 and 60) (March 2015 to February 2022)