International Intestinal Failure Registry
Brief description of study
Detailed description of study
Methods and Procedures
Patients will be enrolled prospectively once ethics committee approval has been obtained and following the signing of an informed consent (for centers needing patient / family informed consent).
For this registry purpose, the date of IF diagnosis is the day of TPN initiation and will be considered ‘study day 0’.
Based on the study definitions of IF, IF is confirmed following 60 days of PN. As a result, IF diagnosis (not ‘date of diagnosis) will be confirmed at the baseline visit at day 60.
Data will be reported at the following times:
Baseline / enrollment data form – at Day 60 after IF diagnosis and up to 60 days after this date.
Six month follow up form – at 6 months after IF diagnosis and up to 90 days after this date.
Annual follow up form – at the annual date after IF diagnosis (e.g at 12 months, 24 months and consecutive years.) and up to 90 days after this date.
Termination form – when a patient no longer wishes to or is not eligible to be a part of the registry (e.g., enteral autonomy, death, transplant, loss to follow up etc.).
Re-enrollment form – when a patient is being re-enrolled into the registry due to recurrence of IF after achieving enteral autonomy or other unique circumstances.
Referral enrollment form – when a referred patient is enrolled into the IIFR (this form replaces the baseline / enrollment data form for referred patients).Researchers will review participants' health history and record relevent health data.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Intestinal failure
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Age: 17 years or below
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Gender: All
Children <18 years of age at time of enrollment
Follow up by an intestinal rehabilitation program as defined by NASPGHAN position statement 2017 (appendix A)
Diagnosis of IF as defined by the need for PN (defined as intravenous solution containing protein, carbohydrate, electrolytes, as well as vitamins and trace elements) for ≥60 days due to a primary underlying gastrointestinal disorder (appendix A). IF etiologies can include short bowel syndrome, motility disorders and congenital diarrhea.
If the center specific ethics committee requires individual consent by patient/parents for participation in this registry, only those patients granting consent will be considered eligible.
Patients will be excluded from the study if:
Their total use of PN was <60 days
Diagnosed with an independently life limiting condition (e.g. malignancy, metabolic or mitochondrial disease)
Receiving PN for ≥60 days but do not have a primary GI disorder (e.g. patients with GVHD, or extreme premature infants on prolonged PN due to intestinal immaturity/feeding intolerance that are eventually weaned off)
Inclusion of a referred patient
A center can enroll a patient who was referred from other non-IIFR center if the patient was referred after the time window of the enrollment visit (more than 120 days after diagnosis of IF). In addition to the above-mentioned inclusion criteria a referred patient must meet the following inclusion criteria:
Date of IF diagnosis is after the date REDCap access was granted to the enrolling center (i.e., the date of the center’s first access to the IIFR)
Data required for a reliable completion of the ‘Referral enrollment form’ is available in the patient’s referral documents
A referred patient has to be TPN dependent and meets the definition of IF
Routine follow up of the referred patient will continue in the IIFR receiving center
Exclusion criteria for referred patients in addition to the above-mentioned exclusion criteria are:
Date of IF diagnosis is before the date REDCap access was granted to the enrolling center
The referred patient is seen for a ‘second opinion’ only and a routine follow up in the IIFR receiving center is not planned
The referred patient is already enrolled and followed by the IIFR*
