To Explore the Efficacy and Safety of Surgical Treatment for Constipation, as Well as the Changes of Postoperative Intestinal Motility, Flora, Nutritional Status and Other Indicators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST).
研究概览
简要总结
Chronic constipation is a heterogeneous disease with multiple symptoms, and its incidence is on the rise in many countries. It has become a common disease affecting the quality of life. When these patients fail to respond to standardized and systematic non-surgical treatment, and the relevant examination suggests that there are surgical indications, surgical treatment should be considered. TThe objective of this study was to explore the efficacy and safety of surgical treatment for constipation, as well as the changes in postoperative nutrition, intestinal motility, intestinal flora and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease duration more than 6 years;
- •Wexner constipation score >15;
- •No response to medical treatment, biofeedback and fecal microbiota transplantation;
- •according to the surgical indications;
- •All patients were informed of this study and signed the informed consent.
排除标准
- •Suffering from mental disorders or cognitive impairment;
- •With malignant tumors; -
- •With history of gastrointestinal surgery;
- •Complicated with other organ dysfunction;
- •With immune system diseases.
结局指标
主要结局
The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST).
时间窗: Baseline and 1、6、12 and 24 months after surgery
The full name of MUST is Malnutrition Universal Screening Tool, score 0: low risk; Score 1: moderate risk; A score of 2 or higher is considered high risk.
The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment （MNA).
时间窗: Baseline and 1、6、12 and 24 months after surgery
Mini Nutritional Assessment (MNA) is defined as "good nutritional status" when MNA≥24. 17≤MNA \< 24, nutritional risk; MNA \< 17 indicated malnutrition.
The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.
时间窗: Baseline and 1、6、12 and 24 months after surgery
The changes of fecal microbiota were detected by 16SDNA sequencing.
时间窗: Baseline and 1、6、12 and 24 months after surgery
Quantitative changes in immune cells were determined by flow cytometry of blood samples.
时间窗: Baseline and 1、6、12 and 24 months after surgery
Changes of intestinal motility after surgical treatment for constipation.
时间窗: Baseline and 1、6、12 and 24 months after surgery
The intestinal transit time of patients was detected
Changes of defecation after surgical treatment for constipation.
时间窗: Baseline and 1、6、12 and 24 months after surgery
The frequency of postoperative defecation, the characteristics of stool and the force of defecation were studied by asking patients to record their defecation diary.
The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002)
时间窗: Baseline and 1、6、12 and 24 months after surgery
The full length of NRS2002 is called Nutritional Risk Screening2022. The minimum score is 0 and the maximum score is 3, with higher scores indicating higher nutritional risk.
Changes of quality of life after surgical treatment for constipation.
时间窗: Baseline and 1、6、12 and 24 months after surgery
Patients were evaluated using the quality of Life assessment scale.
次要结局
未报告次要终点
研究者
Huanlong Qin
Clinical Professor
Shanghai 10th People's Hospital