A Multicentric Observational Retrospective Study on Patients With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Intestinal Transplantation in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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 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))
- Length of Hospitalization Related to SBS-IF Disease(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(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(From start of the study up to end of observation period (up to 10 months))
- 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 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 Anatomy Site(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 Each Type of Intestinal Transplant Performed(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(From start of the study up to end of observation period (up to 10 months))
- Length of the Remaining Bowel(From start of the study up to end of observation period (up to 10 months))