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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
operating time
Time Frame: During surgery
Record the patient's surgical time
During surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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