To Explore the Changes of Nutritional Status, Immune Function, Intestinal Motility and Intestinal Flora in Patients With Constipation Before and After Surgical Treatment

Constipation Clinical Trial

Official title:

The Intestinal Motility, Nutritional Status, Immune Function and Intestinal Environment of Patients Were Evaluated by Measuring BMI, Biochemical Tests and Nutritional Risk Related Questionnaires

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983926
• Other study ID #: STC-20230704
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The cure rate of surgical treatment can reach 95%. The purpose of this study was to evaluate the intestinal motility, nutritional status, immune function and intestinal environment of patients by measuring BMI, biochemical tests and nutritional risk related questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Suffering from mental disorders or cognitive impairment;

• With malignant tumors; -

• With history of gastrointestinal surgery;

• Complicated with other organ dysfunction;

• With immune system diseases.

Related Conditions & MeSH terms

• Constipation
• Surgical Treatment

Intervention

Procedure:
• Subtotal colectomy was performed
Colonic subtotal resection, also known as subtotal colectomy, is a surgical procedure used to treat colonic diseases such asconstipation, colon cancer, ulcerative colitis, and others. The purpose of this surgery is to remove a portion of the colon in the patient's body. Unlike a total colectomy, which involves removing the entire colon, a subtotal colectomy only removes a portion of the colon. The procedure typically involves removing the diseased part of the colon and reconnecting the remaining colon. This allows for the preservation of some normal colonic function, enabling the patient to have regular bowel movements.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022(NRS2002)	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.	Baseline and 6 months after surgery
Primary	The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool (MUST).	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.	Baseline and 6 months after surgery
Primary	The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment (MNA).	Mini Nutritional Assessment (MNA) is defined as "good nutritional status" when MNA=24. 17=MNA < 24, nutritional risk; MNA < 17 indicated malnutrition.	Baseline and 6 months after surgery
Primary	The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.		Baseline and 6 months after surgery
Primary	The changes of fecal microbiota were detected by 16SDNA sequencing.		Baseline and 6 months after surgery
Primary	Quantitative changes in immune cells were determined by flow cytometry of blood samples.		Baseline and 6 months after surgery