Clinical trial NCT05113082: Retrospective Study on Participants With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Transplantation in Brazil
Official title: A Multicentric Observational Retrospective Study on Patients With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Intestinal Transplantation in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome (SBS)
Keywords: Chronic Intestinal Failure
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with SBS-IF that underwent intestinal transplantation in Brazil.

Brief summary: The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil.

This study is about collecting data available in the participant's medical record and will also describe the demographic and clinical characteristics of these participants. No medication will be provided to participants in this study.

Clinical data will be collected from a period up to 10 years before the day of the intestinal transplantation. No clinic visits will be required as part of participation in this study.


Eligibility criteria: Inclusion Criteria

* Participants with a diagnosis of SBS-IF, who underwent intestinal transplantation between April 2011 to April 2021.
* Participants who have signed the informed consent form (or his/her legal representative). For deceased participants or those with lost to follow-up, an informed consent form (ICF) waiver is acceptable.

Primary outcomes:
measure: Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Elapsed Time From the Date of SBS-IF Diagnosis to the Date of Intestinal Transplant Procedure Indication
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Elapsed Time From the Date of Intestinal Transplant Indication to the Date of Intestinal Transplant Procedure
timeFrame: From start of the study up to end of observation period (up to 10 months)
Secondary outcomes:
measure: Volume of Parenteral Nutrition and Fluid (Intravenous [IV]) Support From Site Admission Until Intestinal Transplantation During Intestinal Transplantation
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants With Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants Based on Type of Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants Based on Reasons for Intestinal Transplant Indication
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants Based on Each Type of Intestinal Transplant Performed
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants With Hospitalization Related to SBS-IF Disease Since Site Admission Until Intestinal Transplantation
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Length of Hospitalization Related to SBS-IF Disease
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants With Surgery Performed in SBS-IF Participants
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants Based on Reason/Indication for Hospitalization in SBS-IF Participants
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Percentage of Participants With Each Disease Leading to SBS-IF
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Number of Participants Based on Anatomy Site
timeFrame: From start of the study up to end of observation period (up to 10 months)
measure: Length of the Remaining Bowel
timeFrame: From start of the study up to end of observation period (up to 10 months)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: