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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
| 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. |
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Inclusion Criteria
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Participants with SBS-IF that underwent intestinal transplantation in Brazil.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | SP 05652-900 | Brazil |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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.
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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) |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |