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

Short Bowel Syndrome Clinical Trial

— PRECAR-SGC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06391762
• Other study ID #: 2023PI056
• Status: Completed
• Start date: December 28, 2023
• Est. completion date: January 3, 2024

Study information

• Verified date: April 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Failure
• Short Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tudrej BV, Martinière A, Etonno R, et al. Scores de précarité en pratique clinique. Médecine. 2019;15(3):117-125

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deprivation level	Determine the deprivation level of this population using the f-EDI of each participant	Throughout study completion, an average of 1 month
Secondary	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	Throughout study completion, an average of 1 month