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NCT Number: NCT06596070

Clinical Study of Intestinal Barrier Dysfunction 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?

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Key information

Conditions

Intestinal Barrier Dysfunction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention was carried out

Other

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

Primary outcomes

  1. operating time

    Time frame: During surgery

    Record the patient's surgical time

Secondary outcomes

  1. 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.

  2. 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

  3. Surgical Procedures

    Time frame: During surgery

    Record whether the patient underwent laparoscopic surgery or open surgery

  4. hemorrhage

    Time frame: During surgery

    Record the patient's intraoperative bleeding volume

  5. Albumin

    Time frame: Preoperative and postoperative 24 hours

    Record the patient's albumin levels before and 24 hours after surgery

  6. 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

  7. age

    Time frame: Preoperative

  8. gender

    Time frame: Preoperative

  9. Body Mass Index

    Time frame: Preoperative

  10. diabetes

    Time frame: Preoperative

    Record whether the patient has diabetes

  11. enteral nutrition

    Time frame: The average observation time is 2 weeks after surgery.

    Record the start time of enteral nutrition for patients after surgery.

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

weiming Li

CONTACT

[email protected]

13114225597

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

Clinical Study of Intestinal Barrier Dysfunction in Patients After Gastrointestinal Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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