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

• ClinicalTrials.gov Identifier: NCT05983926
• Recruitment Status: Completed
• First Posted: August 9, 2023
• Last Update Posted: August 14, 2023
• Sponsor: Shanghai 10th People's Hospital
• Information provided by (Responsible Party): Huanlong Qin, Shanghai 10th People's Hospital

Study Description

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. 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.

Condition or disease	Intervention/treatment	Phase
Constipation; Surgical Treatment	Procedure: Subtotal colectomy was performed	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: March 31, 2023
• Actual Study Completion Date: June 30, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: Differences in conditions before and after surgical treatment of constipation

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.

Outcome Measures

Primary Outcome Measures :

1. The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002) [ Time Frame: Baseline and 6 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.
2. The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST). [ Time Frame: Baseline and 6 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.
3. The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment （MNA). [ Time Frame: Baseline and 6 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.
4. The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces. [ Time Frame: Baseline and 6 months after surgery ]
5. The changes of fecal microbiota were detected by 16SDNA sequencing. [ Time Frame: Baseline and 6 months after surgery ]
6. Quantitative changes in immune cells were determined by flow cytometry of blood samples. [ Time Frame: Baseline and 6 months after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Shanghai

Shanghai Tenth People's Hospital

Shanghai, Shanghai, China, 200071

Sponsors and Collaborators

Shanghai 10th People's Hospital

Investigators

• Principal Investigator: Le Wang, Master; Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

More Information

• Responsible Party: Huanlong Qin, Clinical Professor, Shanghai 10th People's Hospital
• ClinicalTrials.gov Identifier: NCT05983926
• Other Study ID Numbers: STC-20230704
• First Posted: August 9, 2023
• Last Update Posted: August 14, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive