Level of Deprivation Assessment in a Population of Short-bowel Syndrome Patients With Intestinal Failure (PRECAR-SGC)

April 25, 2024 updated by: MICHOT Niasha, Central Hospital, Nancy, France

Level of Deprivation Assessment in the Population of Short-bowel Syndrome With Intestinal Failure Patients Monitored by the Nancy University Hospital, France, Between 2020 and 2023

The association between social deprivation and chronic disease is regularly examined but there are no data available on patients with intestinal failure due to short bowel syndrome (SBS-IF). First, the investigators aim to characterize this population and then to assess if insecurity is associated with some disease criteria.

Study Overview

Status

Completed

Conditions

Detailed Description

This exploratory cross-sectional study was conducted on patients affected by intestinal failure in short bowel syndrome and monitored by the certified home parenteral nutrition (HPN) center of Nancy University Hospital.

The investigators included all patients over 18 years old suffering from SBS-IF followed-up by the certified HPN center of Nancy University Hospital between March 1st, 2020, and November 30th, 2023.

The f-EDI (a European ecological index adapted to France) was determined for each participant.

The investigators set the initial date at 2020, as this corresponds to the start of the use of patient-specific formulas in the center. Exclusion criteria were: not living in France, because it's required to use French-EDI and patients under 18 years old because they are monitored by the children's hospital. Investigators also excluded patients with transitory type 1 SBS who would have a bowel length over 2 meters after re-establishment of digestive continuity.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54500
        • CHRU Nancy

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years of age suffering from Short-bowel syndrome with intestinal failure, monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital, between March 1st 2020 and November 30th 2023

Description

Inclusion Criteria:

  • Patients over 18 years of age
  • Suffering from Short-bowel syndrome with intestinal failure
  • Monitored by the Certified Home Parenteral Nutrition Center of the Nancy University Hospital
  • Between March 1st 2020 and November 30th 2023

Exclusion Criteria:

  • Patients not living in France
  • Transitory short-bowel syndrome with a predicted bowel length > 200cm after digestive continuity

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
Deprivation level
Time Frame: Throughout study completion, an average of 1 month
Determine the deprivation level of this population using the f-EDI of each participant
Throughout study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between deprivation level and disease characteristics
Time Frame: Throughout study completion, an average of 1 month
Determine the association between the deprivation level of the patients with SBS-IF determined by f-EDI and the characteristics of their disease
Throughout study completion, an average of 1 month

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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)

December 28, 2023

Primary Completion (Actual)

January 3, 2024

Study Completion (Actual)

January 3, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PI056

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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