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

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Surgical Treatment
• Intervention / Treatment: Procedure: Subtotal colectomy was performed

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: STC-20230704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No