Intestinal Barrier DysfunctionNCT06596070
Clinical Study of Intestinal Barrier Dysfunction After Gastrointestinal Surgery
An observational study of Intestinal Barrier Dysfunction, run by The Second Affiliated Hospital of Kunming Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Barrier Dysfunction
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People undergoing gastrointestinal surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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?
- Conditions
- Intestinal Barrier Dysfunction
- Being tested
- No intervention was carried out
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was carried outOther
This study is an observational study and no intervention was performed on the patients.
| Study group | Role | What they receive |
|---|---|---|
| Intestinal barrier dysfunction group | Not described Receives: Other: No intervention was carried out | |
| Non-intestinal barrier dysfunction group | Not described Receives: Other: No intervention was carried out |
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
Record the patient\'s surgical time
Measured: During surgery
Secondary outcomes (12)
nutritional status
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.
Measured: Preoperative
bowel habit
The patient was asked whether there were increased frequency of stool, changes in stool characteristics, constipation and other conditions before surgery
Measured: Preoperative
Surgical Procedures
Record whether the patient underwent laparoscopic surgery or open surgery
Measured: During surgery
hemorrhage
Record the patient\'s intraoperative bleeding volume
Measured: During surgery
Albumin
Record the patient\'s albumin levels before and 24 hours after surgery
Measured: Preoperative and postoperative 24 hours
Infection indicators
Record the values of PCT, IL-6, and CRP of patients before and 24 hours after surgery
Measured: Preoperative and postoperative 24 hours
age
Measured: Preoperative
gender
Measured: Preoperative
Body Mass Index
Measured: Preoperative
diabetes
Record whether the patient has diabetes
Measured: Preoperative
enteral nutrition
Record the start time of enteral nutrition for patients after surgery.
Measured: The average observation time is 2 weeks after surgery.
Exhaust and defecation time
Record the time of the patient\'s first exhaust and first bowel movement after surgery
Measured: The average observation time is one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Barrier DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Li, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596070
- Sponsor's protocol ID
- PJ-2024-124
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Research not yet completed
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Intestinal Barrier Dysfunction in Patients After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06596070
- Acronym / sponsor ID
- PJ-2024-124
- Conditions
- Intestinal Barrier Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intestinal barrier dysfunction group | – | Other: No intervention was carried out |
| Non-intestinal barrier dysfunction group | – | Other: No intervention was carried out |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People undergoing gastrointestinal surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was carried outThis study is an observational study and no intervention was performed on the patients. | Other | Intestinal barrier dysfunction group, Non-intestinal barrier dysfunction group |
Primary outcome
operating time
Time frame: During surgery
Record the patient\'s surgical time
12 secondary outcomes
nutritional status
Time frame: Preoperative
bowel habit
Time frame: Preoperative
Surgical Procedures
Time frame: During surgery
hemorrhage
Time frame: During surgery
Albumin
Time frame: Preoperative and postoperative 24 hours
Infection indicators
Time frame: Preoperative and postoperative 24 hours
age
Time frame: Preoperative
gender
Time frame: Preoperative
Body Mass Index
Time frame: Preoperative
diabetes
Time frame: Preoperative
enteral nutrition
Time frame: The average observation time is 2 weeks after surgery.
Exhaust and defecation time
Time frame: The average observation time is one week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided. Research not yet completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Barrier Dysfunction, run by The Second Affiliated Hospital of Kunming Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weiming Li (13114225597, liweiming49@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operating time (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.