NCT06596070

Brief 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. The main question it aims to answer is:What clinical factors increase the probability of developing intestinal barrier dysfunction in patients after gastrointestinal surgery?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 7, 2024

Last Update Submit

September 12, 2024

Conditions

Intestinal Barrier Dysfunction

Outcome Measures

Primary Outcomes (1)

  • operating time

    Record the patient\'s surgical time

    During surgery

Secondary Outcomes (12)

  • nutritional status

    Preoperative

  • bowel habit

    Preoperative

  • Surgical Procedures

    During surgery

  • hemorrhage

    During surgery

  • Albumin

    Preoperative and postoperative 24 hours

  • +7 more secondary outcomes

Study Arms (2)

Intestinal barrier dysfunction group

Other: No intervention was carried out

Non-intestinal barrier dysfunction group

Other: No intervention was carried out

Interventions

No intervention was carried outOTHER

This study is an observational study and no intervention was performed on the patients.

Intestinal barrier dysfunction groupNon-intestinal barrier dysfunction group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People undergoing gastrointestinal surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

weiming Li

CONTACT

13114225597liweiming49@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 7, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

January 1, 2025

Study Completion

April 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09