Retrospective Study on Participants With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Transplantation in Brazil

NCT05113082 | Completed

• 1 other identifier: TAK-633-4007
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome (SBS)

Keywords

Chronic Intestinal Failure

Outcome Measures

Primary Outcomes (3)

• Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis

  Elapsed time from the date of underlying condition diagnosis to the date of SBS-IF diagnosis, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.

  From start of the study up to end of observation period (up to 10 months)

• Elapsed Time From the Date of SBS-IF Diagnosis to the Date of Intestinal Transplant Procedure Indication

  Elapsed time from the date of SBS-IF diagnosis to the date of intestinal transplant procedure indication, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.

  From start of the study up to end of observation period (up to 10 months)

• Elapsed Time From the Date of Intestinal Transplant Indication to the Date of Intestinal Transplant Procedure

  Elapsed time from the date of intestinal transplant indication to the date of intestinal transplant procedure, according to the information described in the medical records will be presented using a Kaplan-Meier curve. Elapsed time is defined as the amount of time that passes from the beginning of an event to its end.

  From start of the study up to end of observation period (up to 10 months)

Secondary Outcomes (12)

• Volume of Parenteral Nutrition and Fluid (Intravenous [IV]) Support From Site Admission Until Intestinal Transplantation During Intestinal Transplantation

  From start of the study up to end of observation period (up to 10 months)

• Number of Participants With Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation

  From start of the study up to end of observation period (up to 10 months)

• Number of Participants Based on Type of Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation

  From start of the study up to end of observation period (up to 10 months)

• Number of Participants Based on Reasons for Intestinal Transplant Indication

  From start of the study up to end of observation period (up to 10 months)

• Number of Participants Based on Each Type of Intestinal Transplant Performed

  From start of the study up to end of observation period (up to 10 months)

Study Arms (1)

Participants with SBS-IF

Participants with SBS-IF who as part of standard or routine clinical practice, that underwent intestinal transplantation over the last 10 years (both dead and alive at the time of study enrollment) will be observed in this retrospective observational study for 10 months.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with SBS-IF that underwent intestinal transplantation in Brazil.

You may qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, SP 05652-900, Brazil

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 9, 2021
• Study Start: May 21, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

BR (1)