A Non-randomised External Controlled Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Surgery
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- first flatus time
研究概览
简要总结
Surgery is one of the most frequent treatments of colorectal cancer. However, delayed restoration of intestinal motility is a common phenomenon in patients who undergo colorectal surgery, and may reduce comfort, prevent the early hospital discharge of patients and increase healthcare costs. Gum chewing is a kind of safe and easily accessible sham feeding to stimulate intestinal motility. In addition, prediction models were used to estimate the risk of delayed restoration of intestinal motility after colorectal surgery. Thus, this study is an External Controlled trial that will determine whether stratified application of gum chewing by risk prediction model will enhance restoration of intestinal motility and reduce healthcare costs in paitents undergoing open or laparoscopic colorectal surgery.
详细描述
Background:
Identifying patients at high risk of delayed restoration of intestinal motility at an early stage and adopting individualized interventions is crucial. The risk prediction model can provide a highly accurate, individualized evidence-based risk estimation by identifying risk factors and creating a risk stratification system. In addition, gum chewing is a kind of sham feeding that has been reported to stimulate intestinal motility and emerged as a popular, simple, safe, effective method for enhancing restoration intestinal motility. Thus, this study combines risk prediction model and gum chewing, aiming to use pre- and intraoperative risk factors to predict the risk of delayed restoration of intestinal motility. After creating a risk stratification system, patients with colorectal surgery will be stratified to high-risk group or low-risk group of delayed restoration of intestinal motility.
Objective:
To compare the efficacy and economics of gum chewing in patients undergoing open or laparoscopic colorectal surgery after stratification by a risk prediction model.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed colorectal cancer
- •Undergo open or laparoscopic colorectal surgery
- •Able to give informed consent
- •With normal verbal skills
排除标准
- •Preoperative lower extremity dysfunction
- •Dysphagia before surgery
- •Patients who are discharged ,transferred to another hospital or die within 72
- •hours after surgery
研究组 & 干预措施
gum chewing in high-risk group
Patients will receive enhanced recovery care and gum chewing (three times per day) on the first postoperative morning until oral dietary intake.
干预措施: gum chewing (Dietary Supplement)
Control in low-risk group
Patients only receive Enhanced recovery care, including no administration of intestinal antibiotics; normal diet until 6 hours before surgery; no nasogastric drainage; minimal perioprative intravenous fluid; patient started to ambulate and drink water on the first postoperative day
结局指标
主要结局
first flatus time
时间窗: end of surgery to first passage of flatus, up to 3 days
time to the passage of first flatus
first defecation time
时间窗: end of surgery to first passage of defecation, up to 3 days
time to the first defecation
proportion of delayed restoration of intestinal motility
时间窗: up to 3 days
The proportion of delayed restoration of intestinal motility will be caculated as the number of participants with delayed restoration of intestinal motility divided by the total number of participants enrolled in the study
length of hospital stay
时间窗: up to 30 days (till successful discharge from secondary care to home, up to 30 days)
次要结局
未报告次要终点
研究者
Hui Yang
Principal Investigator
Sichuan Cancer Hospital and Research Institute