癌症患者行胃肠手术后围手术期营养补充优化的生活质量：一项随机、安慰剂对照的可行性临床试验。

Quality of life following perioperative optimization with nutritional supplements in patients undergoing gastrointestinal surgery for cancer: A randomized, placebo-controlled feasibility clinical trial.

机构信息

Department of Surgery, McMaster University, Hamilton, Ontario, Canada.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

出版信息

J Surg Oncol. 2024 Jun;129(7):1289-1294. doi: 10.1002/jso.27624. Epub 2024 Mar 20.

DOI:10.1002/jso.27624

PMID:38504604

Abstract

BACKGROUND

Up to two thirds of patients presenting for abdominal cancer surgery are malnourished pre-operatively. Perioperative nutritional supplementation has been proposed to improve surgical outcomes, though its effect on quality of life (QoL) is not yet understood.

METHODS

A randomized controlled feasibility trial for perioperative nutrition among patients undergoing major abdominal cancer surgery was conducted. Participants in the intervention group received supplements for 30 days before surgery. Participants completed two QoL questionnaires (EORTC-QLQ-C-30 and FACT-G) at baseline, then 4 and 12 weeks postoperatively. Participants were compared between and within groups at baseline, Weeks 4, and 12 using t tests. Minimal clinically important differences (MCIDs) were considered as a 10-point worsening from baseline.

RESULTS

Sixty-six participants were available for analysis in this study, including 33 in the intervention and 30 in the control arms. Baseline demographics were balanced between groups except for different rates of pancreas cancer (36% intervention vs. 9% control) and colorectal cancer (19% intervention vs. 34% control). At baseline, participants in the intervention group had lower overall QoL (59% vs. 77%, p = 0.01), role functioning (72% vs 88%, p = 0.045), and cognitive functioning (79% vs 90%, p = 0.047). Following surgery, role and physical functioning worsened in the control group, without significant differences between groups. Role functioning was persistently worsened at 12 weeks in the control group. The rates of MCIDs were similar between both intervention and control groups.

DISCUSSION

Perioperative nutrition was associated with preservation of QoL in the postoperative period following major abdominal cancer surgery compared to placebo.

SUMMARY

Among patients undergoing surgery for cancer, the majority present at high risk for malnutrition. In this placebo-controlled randomized trial among patients undergoing major abdominal surgery for cancer, preoperative nutrition supplementation was associated with the preservation of QoL in the postoperative period.

摘要

背景

多达三分之二的腹部癌症手术患者术前存在营养不良。围手术期营养补充被提议用于改善手术结果，但它对生活质量（QoL）的影响尚不清楚。

方法

对接受大型腹部癌症手术的患者进行了围手术期营养的随机对照可行性试验。干预组的参与者在术前 30 天内接受补充剂。参与者在基线时完成了两个 QoL 问卷（EORTC-QLQ-C-30 和 FACT-G），然后在术后 4 周和 12 周时完成。使用 t 检验在基线、第 4 周和第 12 周时比较组间和组内差异。最小临床重要差异（MCID）被认为是与基线相比恶化 10 分。

结果

本研究共纳入 66 名患者，其中干预组 33 例，对照组 30 例。除胰腺癌（36%干预组 vs. 9%对照组）和结直肠癌（19%干预组 vs. 34%对照组）的发生率不同外，两组基线人口统计学特征平衡。在基线时，干预组患者的总体 QoL（59% vs. 77%，p=0.01）、角色功能（72% vs. 88%，p=0.045）和认知功能（79% vs. 90%，p=0.047）较低。手术后，对照组患者的角色和身体功能恶化，两组间无显著差异。对照组患者的角色功能在 12 周时仍持续恶化。两组的 MCID 发生率相似。