NCT04867538

Brief Summary

Short-term studies have shown that patients with short bowel syndrome (SBS) often develop cholestasis or cholelithiasis. In this retrospective cohort study, we aimed to define the incidence, risk factors, and clinical consequences of cholelithiasis in adults with SBS over an extended time period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

10 years

First QC Date

April 27, 2021

Last Update Submit

April 27, 2021

Conditions

Short Bowel Syndrome

Keywords

Short bowel syndromeCholelithiasisPrevalenceRisk factors

Outcome Measures

Primary Outcomes (3)

  • the incidence of cholelithiasis in patients with SBS

    the incidence of symptomatic and asymptomatic cholelithiasis in a cohort of patients with SBS

    2010/1/1-2019/12/31

  • risk factors

    the risk factors of cholelithiasis in patients with SBS

    2010/1/1-2019/12/31

  • complications

    the clinical consequences of cholelithiasis in patients with SBS

    2010/1/1-2019/12/31

Interventions

no interventionOTHER

No intervention

Eligibility Criteria

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

SBS was defined as intestinal malabsorption disorder caused by extensive bowel resection with a remnant small intestine length of \<200cm

You may qualify if:

  • All eligible adults diagnosed with SBS

You may not qualify if:

  • age \<18 years; history of cholelithiasis before SBS diagnosis; cholecystectomy; biliary tract obstruction or no abdominal imaging (CT, MRI, or ultrasound) after SBS diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gao X, Zhang L, Wang S, Xiao Y, Song D, Zhou D, Wang X. Prevalence, Risk Factors, and Complications of Cholelithiasis in Adults With Short Bowel Syndrome: A Longitudinal Cohort Study. Front Nutr. 2021 Nov 29;8:762240. doi: 10.3389/fnut.2021.762240. eCollection 2021.

    PMID: 34912839DERIVED

MeSH Terms

Conditions

Short Bowel SyndromeCholelithiasis

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBiliary Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share