Level of Deprivation Assessment in a Population of Short-bowel Syndrome Patients With Intestinal Failure

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.

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Key information

Conditions

Short Bowel Syndrome Deprivation, Psychosocial Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Failure Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: PRECAR-SGC

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Apr 30, 2024
Registry last updated: Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed