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老年结肠癌择期结肠切除术患者肠道微生物群与术后胃肠功能障碍的关系:一项前瞻性观察队列研究方案。

Relation of gut microbiota and postoperative gastrointestinal dysfunction in older patients with colon cancer undergoing elective colon resection: a protocol for a prospective, observational cohort study.

机构信息

West China School of Nursing, Sichuan University/ West China Hospital, Sichuan University, Chengdu, China.

West China School of Public Health, Sichuan University, Chengdu, China.

出版信息

BMJ Open. 2022 Sep 8;12(9):e057391. doi: 10.1136/bmjopen-2021-057391.

Abstract

INTRODUCTION

Gut microbiota (GM) appears critical for gastrointestinal symptoms, but whether alterations in GM are associated with increased risk of postoperative gastrointestinal dysfunction (POGID) in older patients with colon cancer (CC) undergoing elective colon resection remains unclear.

METHODS AND ANALYSIS

This study aims to prospectively recruit 284 elderly patients with CC undergoing elective colon resection. GM of fresh faeces specimens is characterised using 16S rRNA gene sequencing. Data are collected preoperatively, daily postoperatively during the in-hospital stay, and follow-up visits are scheduled four times within 30 days after discharge. Associations with POGID will be investigated using logistic regression models to calculate ORs with 95% CIs. The models include the adjustment for age, sex, frequency of spicy diet, coffee drinking and tea drinking, tobacco and alcohol history, diabetes, obesity, gastroenteritis, preoperative gut microbial composition. Furthermore, we will use joint modelling for longitudinal data to study several outcome variables simultaneously.

ETHICS AND DISSEMINATION

This study was approved by the Institutional Review Board of West China Hospital, Sichuan University (IRB Number: 20201334). The results will be disseminated through peer-reviewed publications or conference presentations.

TRIAL REGISTRATION NUMBER

It has been registered in PROSPERO, number CRD42019145032. It has been registered in the Chinese clinical trial registry, number ChiCTR2100043646.

摘要

简介

肠道微生物群(GM)似乎对胃肠道症状至关重要,但 GM 的改变是否与接受择期结肠切除术的老年结肠癌(CC)患者术后胃肠道功能障碍(POGID)的风险增加相关,目前尚不清楚。

方法和分析

本研究旨在前瞻性招募 284 名接受择期结肠切除术的老年 CC 患者。使用 16S rRNA 基因测序对新鲜粪便标本中的 GM 进行特征分析。数据在术前、住院期间每天术后以及出院后 30 天内安排四次随访时收集。使用逻辑回归模型对 POGID 进行关联分析,计算 95%置信区间的 OR。这些模型包括年龄、性别、辛辣饮食、咖啡饮用和茶饮用频率、吸烟和饮酒史、糖尿病、肥胖、肠胃炎、术前肠道微生物组成的调整。此外,我们将使用联合建模对纵向数据进行研究,以同时研究多个结果变量。

伦理和传播

本研究已获得四川大学华西医院机构审查委员会的批准(IRB 编号:20201334)。结果将通过同行评审的出版物或会议演示进行传播。

试验注册号

它已在 PROSPERO 中注册,编号为 CRD42019145032。它已在中国临床试验注册中心注册,编号为 ChiCTR2100043646。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/859a/9462128/d1f0fcf1e290/bmjopen-2021-057391f01.jpg

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