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临床试验/NCT06256133
NCT06256133已完成不适用

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

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
355
试验地点
1
主要终点
Short- and long-term mortality

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Short- and long-term mortality

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

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

次要结局

  • Length of stay(Postoperative, through study completion (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))
  • Inflammatory parameters(On the day before surgery and postoperative day 7 ((March 2015 to February 2022))
  • Weight change(Pre- and Postoperative(postoperative days 30 and 60) (March 2015 to February 2022))
  • ERAS protocol adherence(Pre-, intraop-, postoperative (during hospitalization) (March 2015 to February 2022))
  • Morbidity rate(Within 3 months after surgery (March 2015 to February 2022))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyemee Kwon

Assistant professor

Asan Medical Center

研究点 (1)

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