T-RexNon-interventional, Multicenter Retrospective Study of the Effectiveness and Safety of Teduglutide (Revestive®) in Short Bowel Syndrome Adult Patients in Spain (T-Rex Study)
Data Collection
Collected from past medical records and data - RetrospectiveDigestive System Diseases+5
+ Gastrointestinal Diseases
+ Intestinal Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 26, 2022
Actual date on which the first participant was enrolled.The main aims of the study are to assess the safety profile of teduglutide (Revestive®) as well as how many people with Short Bowl Syndrome experience a reduction of parenteral support when treated with teduglutide (Revestive®). This study is about collecting existing data only; participants will not receive teduglutide (Revestive®) as part of this study. No new information will be collected during this study. Only data already available in the hospital records will be reviewed and collected for this study. Participants do not need to visit their doctor in addition to their normal visits.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.65 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Participants \>= 18 years of age diagnosed with intestinal failure due to SBS as a result of intestinal resection. * SBS-IF participants treated with teduglutide according to Summary of Product Characteristics (SmPC). * Patients who receive or have received teduglutide for at least six months at the date of inclusion (from treatment initiation to inclusion date, date of discontinuation, death for any cause or loss of follow-up). * When required by the ethics committee of the center: participants who have signed the informed consent form (ICF) to participate in the study. Exclusion Criteria: \- Participants who do not meet the inclusion criteria.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, SpainOpen Hospital Universitari de Bellvitge in Google Maps