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Survival and PN Dependence in SBS Patients

Sponsor
The First Affiliated Hospital of University of Science and Technology of China (Other)
Overall Status
Completed
CT.gov ID
NCT06102668
Collaborator
Jinling Hospital, China (Other)
173
Enrollment
84
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    173 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Long-term Survival and Parenteral Nutrition Dependence in Adult Patients With Non-malignant Short Bowel Syndrome
    Actual Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2019
    Actual Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Survival [2012/1/1-2019/1/1]

      Survival rate in patients with SBS

    2. Parenteral nutrition dependence [2012/1/1-2019/1/1]

      Parenteral nutrition dependence in patients with SBS

    Secondary Outcome Measures

    1. Risk factors [2012/1/1-2019/1/1]

      Risk factors of mortality and parenteral dependence in patients with SBS

    2. Cause of death [2012/1/1-2019/1/1]

      Cause of death in patients with SBS at the end of follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients diagnosed with SBS.
    Exclusion Criteria:
    • age <18 years; patients with active malignant tumors.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital of University of Science and Technology of China
    • Jinling Hospital, China

    Investigators

    • Principal Investigator: JIANFENG GONG, M.D., Jinling Hospital, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital of University of Science and Technology of China
    ClinicalTrials.gov Identifier:
    NCT06102668
    Other Study ID Numbers:
    • FirstAHUSTChina
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Short Bowel Syndrome
    Syndrome

    Study Results

    No Results Posted as of Oct 26, 2023