Clinical Study of Intestinal Barrier Dysfunction After Gastrointestinal Surgery

September 12, 2024 updated by: Weiming Li, The Second Affiliated Hospital of Kunming Medical University

Clinical Study of Intestinal Barrier Dysfunction in Patients After Gastrointestinal Surgery

The goal of this observational study is to explore the clinical influences associated with the development of intestinal barrier dysfunction in patients undergoing gastrointestinal surgery. The main question it aims to answer is:What clinical factors increase the probability of developing intestinal barrier dysfunction in patients after gastrointestinal surgery?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People undergoing gastrointestinal surgery

Description

Inclusion Criteria:

  • men or women aged 18-80 years
  • expected feasible abdominal surgical treatment (partial gastrectomy, colorectal resection)
  • no preoperative intestinal barrier dysfunction
  • patients voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

  • Patients or their families refused to participate in this study
  • chronic inflammatory diseases (e.g. inflammatory bowel disease, chronic hepatitis, chronic pancreatitis, chronic peptic ulcer, etc.)
  • history of antibiotic administration in the last 2 weeks
  • severe cognitive impairment and other inability to cooperate preoperative neoadjuvant radiotherapy
  • combined with severe hepatic, renal, and cardiac insufficiency patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intestinal barrier dysfunction group
Other: No intervention was carried out
This study is an observational study and no intervention was performed on the patients.
Non-intestinal barrier dysfunction group
Other: No intervention was carried out
This study is an observational study and no intervention was performed on the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operating time
Time Frame: During surgery
Record the patient's surgical time
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutritional status
Time Frame: Preoperative
Patients were assessed for risk of malnutrition by the Nutritional Risk Screening Scale (NRS-2002). A score of ≥3 indicated that the patient was at risk of malnutrition.
Preoperative
bowel habit
Time Frame: Preoperative
The patient was asked whether there were increased frequency of stool, changes in stool characteristics, constipation and other conditions before surgery
Preoperative
Surgical Procedures
Time Frame: During surgery
Record whether the patient underwent laparoscopic surgery or open surgery
During surgery
hemorrhage
Time Frame: During surgery
Record the patient's intraoperative bleeding volume
During surgery
Albumin
Time Frame: Preoperative and postoperative 24 hours
Record the patient's albumin levels before and 24 hours after surgery
Preoperative and postoperative 24 hours
Infection indicators
Time Frame: Preoperative and postoperative 24 hours
Record the values of PCT, IL-6, and CRP of patients before and 24 hours after surgery
Preoperative and postoperative 24 hours
age
Time Frame: Preoperative
Preoperative
gender
Time Frame: Preoperative
Preoperative
Body Mass Index
Time Frame: Preoperative
Preoperative
diabetes
Time Frame: Preoperative
Record whether the patient has diabetes
Preoperative
enteral nutrition
Time Frame: The average observation time is 2 weeks after surgery.
Record the start time of enteral nutrition for patients after surgery.
The average observation time is 2 weeks after surgery.
Exhaust and defecation time
Time Frame: The average observation time is one week after surgery
Record the time of the patient's first exhaust and first bowel movement after surgery
The average observation time is one week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Kunming Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

September 7, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PJ-2024-124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Research not yet completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intestinal Barrier Dysfunction

Clinical Trials on No intervention was carried out

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe