An observational study in Chronic Intestinal Failure and Small Intestine Disease, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners
Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF.
Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included.
After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 19 observational studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women aged 18 and over, fulfilling the conditions of major Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 semi-structured interviews
Qualitative data analysis - Theorical saturation
Time frame: 12 months
No study locations are listed for this record.
Start is estimated for Oct 2020; primary completion for Dec 2021, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon →