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

A Multicentric Observational Retrospective Study on Patients With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Intestinal Transplantation in Brazil

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.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome (SBS)

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, SP 05652-900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of Parenteral Nutrition and Fluid (Intravenous [IV]) Support From Site Admission Until Intestinal Transplantation During Intestinal Transplantation	Volume (milliliter/day [mL/day]) of parenteral nutrition and fluid (IV) support from site admission until intestinal transplantation will be summarized using descriptive statistics. Parenteral nutrition is the feeding of nutritional products to a person intravenously, by passing the usual process of eating and digestion.	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	Number of participants with parenteral nutrition and fluid (IV) support from site admission until intestinal transplantation will be summarized using descriptive statistics. Number of participants with parenteral nutrition and fluid support is calculated by day/week. Parenteral nutrition is the feeding of nutritional products to a person intravenously, by passing the usual process of eating and digestion.	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	Number of Participants based on type (ready to use or individualized) of parenteral nutrition and fluid (IV) support from site admission until intestinal transplantation will be summarized using descriptive statistics. Parenteral nutrition is the feeding of nutritional products to a person intravenously, bypassing the usual process of eating and digestion.	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	Number of Participants based on reasons for Intestinal Transplant Indication will be summarized using descriptive statistics.	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	Number of participants based on each type of intestinal transplant will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)
Number of Participants With Hospitalization Related to SBS-IF Disease Since Site Admission Until Intestinal Transplantation	Number of participants with hospitalizations per patient per year will be calculated based on the number of hospitalizations during the follow-up period.	From start of the study up to end of observation period (up to 10 months)
Length of Hospitalization Related to SBS-IF Disease	Length of hospitalization (days) related to SBS-IF disease since site admission until intestinal transplantation will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)
Number of Participants With Surgery Performed in SBS-IF Participants	Number of participants with surgery performed in SBS-IF participants since site admission to intestinal transplantation will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Reason/Indication for Hospitalization in SBS-IF Participants	Number of participants based on reason/indication for hospitalization by SBS-IF participants since site admission to intestinal transplantation will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)
Percentage of Participants With Each Disease Leading to SBS-IF	Percentage of participants with each disease/cause leading to SBS-IF will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)
Number of Participants Based on Anatomy Site	Number of participants based on anatomy site will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)
Length of the Remaining Bowel	Length of the remaining bowel will be summarized using descriptive statistics.	From start of the study up to end of observation period (up to 10 months)

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2022
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Intestinal Failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: TAK-633-4007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No