The Cholelithiasis in Adults With Short Bowel Syndrome

April 27, 2021 updated by: Wang Xinying, Jinling Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of cholelithiasis in patients with SBS
Time Frame: 2010/1/1-2019/12/31
the incidence of symptomatic and asymptomatic cholelithiasis in a cohort of patients with SBS
2010/1/1-2019/12/31
risk factors
Time Frame: 2010/1/1-2019/12/31
the risk factors of cholelithiasis in patients with SBS
2010/1/1-2019/12/31
complications
Time Frame: 2010/1/1-2019/12/31
the clinical consequences of cholelithiasis in patients with SBS
2010/1/1-2019/12/31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2010

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (ACTUAL)

April 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201502022-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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