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
- Conditions
- Surgical TreatmentConstipation
- Interventions
- Procedure: Subtotal colectomy was performed
- Registration Number
- NCT05983926
- Lead Sponsor
- Shanghai 10th People's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- Suffering from mental disorders or cognitive impairment;
- With malignant tumors; -
- With history of gastrointestinal surgery;
- Complicated with other organ dysfunction;
- With immune system diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Differences in conditions before and after surgical treatment of constipation Subtotal colectomy was performed -
- Primary Outcome Measures
Name Time Method The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST). 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). 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. Baseline and 1、6、12 and 24 months after surgery The changes of fecal microbiota were detected by 16SDNA sequencing. Baseline and 1、6、12 and 24 months after surgery Quantitative changes in immune cells were determined by flow cytometry of blood samples. Baseline and 1、6、12 and 24 months after surgery Changes of intestinal motility after surgical treatment for constipation. 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. 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) 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. Baseline and 1、6、12 and 24 months after surgery Patients were evaluated using the quality of Life assessment scale.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China