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

Short Bowel Syndrome (SBS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113082
• Other study ID #: TAK-633-4007
• Status: Completed
• Start date: May 21, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: November 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Short Bowel Syndrome (SBS)
• Syndrome

Locations

Country	Name	City	State
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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