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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05983926
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
41.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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
  • Procedure: Subtotal colectomy was performed
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2020
Actual Primary Completion Date :
Mar 31, 2023
Actual Study Completion Date :
Jun 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) [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). [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). [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. [Baseline and 6 months after surgery]

  5. The changes of fecal microbiota were detected by 16SDNA sequencing. [Baseline and 6 months after surgery]

  6. Quantitative changes in immune cells were determined by flow cytometry of blood samples. [Baseline and 6 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huanlong Qin, Clinical Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT05983926
Other Study ID Numbers:
  • STC-20230704
First Posted:
Aug 9, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
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

Study Results

No Results Posted as of Aug 14, 2023