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CompletedNCT06391762PRECAR-SGCUpdated Apr 30, 2024

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

An observational study in Short Bowel Syndrome, Intestinal Failure and Deprivation, Psychosocial, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
92
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Short Bowel Syndrome
  • Intestinal Failure
  • Deprivation, Psychosocial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
92 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Deprivation level

    Determine the deprivation level of this population using the f-EDI of each participant

    Time frame: Throughout study completion, an average of 1 month

Secondary outcomes

  1. Association between deprivation level and disease characteristics

    Determine the association between the deprivation level of the patients with SBS-IF determined by f-EDI and the characteristics of their disease

    Time frame: Throughout study completion, an average of 1 month

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Study locations

1 site
  • CHRU Nancy
    Vandœuvre-lès-Nancy, Lorraine 54500, France
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References and documents

Publications

  • Tudrej BV, Martinière A, Etonno R, et al. Scores de précarité en pratique clinique. Médecine. 2019;15(3):117-125
  • Merville O, Launay L, Dejardin O, Rollet Q, Bryere J, Guillaume E, Launoy G. Can an Ecological Index of Deprivation Be Used at the Country Level? The Case of the French Version of the European Deprivation Index (F-EDI). Int J Environ Res Public Health. 2022 Feb 17;19(4):2311. doi: 10.3390/ijerph19042311. PubMed 35206501 ↗
  • Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Muhlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN practical guideline: Home parenteral nutrition. Clin Nutr. 2023 Mar;42(3):411-430. doi: 10.1016/j.clnu.2022.12.003. Epub 2023 Jan 9. PubMed 36796121 ↗
  • Pironi L. Definitions of intestinal failure and the short bowel syndrome. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):173-85. doi: 10.1016/j.bpg.2016.02.011. Epub 2016 Feb 18. PubMed 27086884 ↗
  • Pironi L, Steiger E, Joly F, Jeppesen PB, Wanten G, Sasdelli AS, Chambrier C, Aimasso U, Mundi MS, Szczepanek K, Jukes A, Theilla M, Kunecki M, Daniels J, Serlie M, Poullenot F, Cooper SC, Rasmussen HH, Compher C, Seguy D, Crivelli A, Santarpia L, Guglielmi FW, Kozjek NR, Schneider SM, Ellegard L, Thibault R, Matras P, Matysiak K, Van Gossum A, Forbes A, Wyer N, Taus M, Virgili NM, O'Callaghan M, Chapman B, Osland E, Cuerda C, Udvarhelyi G, Jones L, Won Lee AD, Masconale L, Orlandoni P, Spaggiari C, Diez MB, Doitchinova-Simeonova M, Serralde-Zuniga AE, Olveira G, Krznaric Z, Czako L, Kekstas G, Sanz-Paris A, Jauregui MEP, Murillo AZ, Schafer E, Arends J, Suarez-Llanos JP, Youssef NN, Brillanti G, Nardi E, Lal S; Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN; European Society for Clinical Nutrition and Metabolism. Characteristics of adult patients with chronic intestinal failure due to short bowel syndrome: An international multicenter survey. Clin Nutr ESPEN. 2021 Oct;45:433-441. doi: 10.1016/j.clnesp.2021.07.004. Epub 2021 Jul 28. PubMed 34620351 ↗
  • Calvar E, Launay L, Boyer A, Launoy G, Lobbedez T, Chatelet V. Effects of Social Deprivation on the Proportion of Preemptive Kidney Transplantation: A Mediation Analysis. Transplant Direct. 2021 Sep 7;7(10):e750. doi: 10.1097/TXD.0000000000001203. eCollection 2021 Oct. PubMed 36567853 ↗
  • Winkler MF, Smith CE. Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):32S-37S. doi: 10.1177/0148607113517717. Epub 2014 Jan 13. PubMed 24418898 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT06391762
Lead sponsor
Central Hospital, Nancy, France
Responsible party
MICHOT Niasha (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Apr 30, 2024
Start date
Dec 28, 2023
Primary completion
Jan 3, 2024
Completion
Jan 3, 2024
Last update
Apr 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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