Clinical trial NCT06391762: Level of Deprivation Assessment in a Population of Short-bowel Syndrome Patients With Intestinal Failure
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Intestinal Failure
Deprivation, Psychosocial
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Deprivation level
timeFrame: Throughout study completion, an average of 1 month
Secondary outcomes:
measure: Association between deprivation level and disease characteristics
timeFrame: Throughout study completion, an average of 1 month
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
state: Lorraine
Study officials:
References:
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