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ImpRovE underSTanding of Short bOwel syndRome in Latin-amErica

NCT04976075 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-08-20

No results posted yet for this study

Summary

Background and justification: Short bowel syndrome (SBS) is a disabling and life-threatening condition that results from a partial or total bowel resection, and has become as the main cause of Type III, intestinal failure (IF). Immediately after enterectomy there is an adaptation process consisting of structural, hormonal and metabolic changes to maximize intestinal function. These changes begin within days of resection and generally continue for several months. However, recent publications have reported even longer periods of time (up to 5 years) to achieve enteral autonomy.

It is possible to enhance the natural process of intestinal adaptation through medical or surgical treatments, called intestinal rehabilitation. During the process, complications related to intestinal failure or its treatment may arise, jeopardizing the result and even compromising survival. A better understanding of the medium and long-term results of patients under medical and / or surgical treatment with SIC is needed.

Despite the improvement recently achieved in managing IF, in most countries, pts are dispersed and seen by general health-care providers, with limited SBS or IF experience, causing increasing concern regarding the competence and equity of the care accessible to suffering pts.

The results obtained with the RESTORE project in adult patients highlight the relevance of having registries to better understand the natural history of this disease in adult patients, proving that a larger number of adult pts with SBS/III-IF can be identified and cared for than the numbers considered by recognized estimations. \[Abstract sent to TTS, 2020\].

To date, there are no data for pediatric patients with iIF secondary to SIC in Latin America, so its incidence, prevalence and evolution are unknown. Recent publications from middle-income countries, exposed the current inequality regarding the different types of therapies available within a given region.

Given the high morbidity and mortality associated with ICS-FI, there is an unmet need to create an adequate study that provides the information necessary to establish local and regional parameters and recommendations on its treatment.

Conditions

  • Short Bowel Syndrome

Interventions

OTHER

no interventions

no interventions

Sponsors & Collaborators

  • Fundación de Ciencias Exactas - UNLP

    collaborator UNKNOWN

  • La Fundacion Favaloro para la Investigacion y la Docencia Medica

    lead OTHER

Principal Investigators

  • Gabriel Gondolesi, Doctor · University Hospital of the Favaloro Foundation

Eligibility

Min Age
1 Week
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976075 on ClinicalTrials.gov