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Completed

NCT Number: NCT05113082

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

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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Key information

Conditions

Short Bowel Syndrome (SBS) Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, SP 05652-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Elapsed Time From the Date of Underlying Condition Diagnosis to the Date of SBS-IF Diagnosis

    Time frame: 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.

  2. Elapsed Time From the Date of SBS-IF Diagnosis to the Date of Intestinal Transplant Procedure Indication

    Time frame: 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.

  3. Elapsed Time From the Date of Intestinal Transplant Indication to the Date of Intestinal Transplant Procedure

    Time frame: 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.

Secondary outcomes

  1. Volume of Parenteral Nutrition and Fluid (Intravenous [IV]) Support From Site Admission Until Intestinal Transplantation During Intestinal Transplantation

    Time frame: 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.

  2. Number of Participants With Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation

    Time frame: 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.

  3. Number of Participants Based on Type of Parenteral Nutrition and Fluid (IV) Support From Site Admission Until Intestinal Transplantation

    Time frame: 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.

  4. Number of Participants Based on Reasons for Intestinal Transplant Indication

    Time frame: 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.

  5. Number of Participants Based on Each Type of Intestinal Transplant Performed

    Time frame: 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.

  6. Number of Participants With Hospitalization Related to SBS-IF Disease Since Site Admission Until Intestinal Transplantation

    Time frame: 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.

  7. Length of Hospitalization Related to SBS-IF Disease

    Time frame: 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.

  8. Number of Participants With Surgery Performed in SBS-IF Participants

    Time frame: 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.

  9. Number of Participants Based on Reason/Indication for Hospitalization in SBS-IF Participants

    Time frame: 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.

  10. Percentage of Participants With Each Disease Leading to SBS-IF

    Time frame: 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.

  11. Number of Participants Based on Anatomy Site

    Time frame: 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.

  12. Length of the Remaining Bowel

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2021
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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