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NCT04867538 Clinical Trial

The Cholelithiasis in Adults With Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

Official title:
Prevalence, Risk Factors, and Complications of Cholelithiasis in Adults With Short Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04867538
Other study ID # 201502022-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2020

Study information
Verified date April 2021
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

However, only limited data are available regarding cholelithiasis in patients with SBS. The prevalence of cholelithiasis in patients with SBS has been reported only in two studies. Furthermore, few studies have focused on identifying the risk factors for cholelithiasis in patients with SBS. Considering the marked improvements in medical care and nutrition support during the last 2 decades, the current incidence and risk factors for cholelithiasis in patients with SBS are unknown. The aim of the current study was to provide comprehensive, longitudinal, and long-term data on the incidence of symptomatic and asymptomatic cholelithiasis in a cohort of patients with SBS, in order to identify the prevalence, risk factors, and clinical consequences of cholelithiasis in patients with SBS to aid in the development of protective interventions.

Recruitment information / eligibility
Status Completed
Enrollment 345
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All eligible adults diagnosed with SBS Exclusion Criteria: age <18 years; history of cholelithiasis before SBS diagnosis; cholecystectomy; biliary tract obstruction or no abdominal imaging (CT, MRI, or ultrasound) after SBS diagnosis.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
No intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jinling Hospital, China

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary risk factors the risk factors of cholelithiasis in patients with SBS 2010/1/1-2019/12/31
Primary complications the clinical consequences of cholelithiasis in patients with SBS 2010/1/1-2019/12/31
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