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

NCT05983926 | Completed

• 1 other identifier: STC-20230704
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Surgical Treatment

Outcome Measures

Primary Outcomes (9)

• 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 1、6、12 and 24 months after surgery

• 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 1、6、12 and 24 months after surgery

• 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 1、6、12 and 24 months after surgery

• 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.

  The intestinal transit time of patients was detected

  Baseline and 1、6、12 and 24 months after surgery

• Changes of defecation after surgical treatment for constipation.

  The frequency of postoperative defecation, the characteristics of stool and the force of defecation were studied by asking patients to record their defecation diary.

  Baseline and 1、6、12 and 24 months after surgery

• Changes of quality of life after surgical treatment for constipation.

  Patients were evaluated using the quality of Life assessment scale.

  Baseline and 1、6、12 and 24 months after surgery

Study Arms (1)

Differences in conditions before and after surgical treatment of constipation

EXPERIMENTAL

Procedure: Subtotal colectomy was performed

Interventions

Subtotal colectomy was performed PROCEDURE

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.

Differences in conditions before and after surgical treatment of constipation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suffering from mental disorders or cognitive impairment;
• With malignant tumors; -
• With history of gastrointestinal surgery;
• Complicated with other organ dysfunction;
• With immune system diseases.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200071, China

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Le Wang, Master

  Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 9, 2023
• Study Start: January 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CN (1)