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

Study Overview
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Brief Summary
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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.

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

Conditions
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Short Bowel Syndrome (SBS)

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with SBS-IF<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Intestinal Failure