Back to results

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

Primary Purpose

Constipation, Surgical Treatment

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Subtotal colectomy was performed

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Differences in conditions before and after surgical treatment of constipation

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.

The changes of fecal microbiota were detected by 16SDNA sequencing.

Quantitative changes in immune cells were determined by flow cytometry of blood samples.

Secondary Outcome Measures

Full Information

NCT ID

NCT05983926

First Posted

July 3, 2023

Last Updated

August 8, 2023

Sponsor

Shanghai 10th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05983926

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation, Surgical Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Differences in conditions before and after surgical treatment of constipation

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Subtotal colectomy was performed

Intervention Description

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.

Primary Outcome Measure Information:

Title

The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002)

Description

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.

Time Frame