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

Completed

• Conditions: Short Bowel Syndrome (SBS)

• Registration Number: NCT05113082
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-09
• Study Start: 2022-05-21
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis	From start of the study up to end of observation period (up to 10 months)	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.
Elapsed Time From the Date of Intestinal Transplant Indication to the Date of Intestinal Transplant Procedure	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, 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.
Elapsed Time From the Date of SBS-IF Diagnosis to the Date of Intestinal Transplant Procedure Indication	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, 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.

Secondary Outcome Measures

Name	Time	Method
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 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.
Number of Participants With Hospitalization Related to SBS-IF Disease Since Site Admission Until Intestinal Transplantation	From start of the study up to end of observation period (up to 10 months)	Number of participants with hospitalizations per patient per year will be calculated based on the number of hospitalizations during the follow-up period.
Length of Hospitalization Related to SBS-IF Disease	From start of the study up to end of observation period (up to 10 months)	Length of hospitalization (days) related to SBS-IF disease since site admission until intestinal transplantation will be summarized using descriptive statistics.
Number of Participants Based on Reason/Indication for Hospitalization in SBS-IF Participants	From start of the study up to end of observation period (up to 10 months)	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.
Percentage of Participants With Each Disease Leading to SBS-IF	From start of the study up to end of observation period (up to 10 months)	Percentage of participants with each disease/cause leading to SBS-IF will be summarized using descriptive statistics.
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)	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.
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 reasons for Intestinal Transplant Indication will be summarized using descriptive statistics.
Number of Participants Based on Anatomy Site	From start of the study up to end of observation period (up to 10 months)	Number of participants based on anatomy site will be summarized using descriptive statistics.
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 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.
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)	Number of participants based on each type of intestinal transplant will be summarized using descriptive statistics.
Number of Participants With Surgery Performed in SBS-IF Participants	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 since site admission to intestinal transplantation will be summarized using descriptive statistics.
Length of the Remaining Bowel	From start of the study up to end of observation period (up to 10 months)	Length of the remaining bowel will be summarized using descriptive statistics.

Trial Locations

Locations (1)

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein; 🇧🇷 São Paulo, Brazil