ImpRovE underSTanding of Short bOwel syndRome in Latin-amErica

NCT04976075 | Unknown DMC

• 1 other identifier: DDI 1384 1317 CBE 666-17
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Describe the long term outcome of Type III-IF patients with short bowel syndrome in Latinoamérica.

  The number of patients with short bowel syndrome/year, the number of patients able to recover intestinal sufficiency under the current available therapy that includes a) PN, b) medical and / or surgical rehabilitation, under the routine clinical practice in Latin American countries, will be reported. Long term survival (in months), freedom from Home Parenteral Nutrition survival in months, as measure for PN independence or recovery of intestinal insufficiency will be measured. The existence on post-surgical complications will be reported by using the Dindo-Clavien classification score (from 0 to 5).

  April 2023

Secondary Outcomes (7)

• Describe the demographic characteristics and distribution of the disease

  April 2023

• Describe the nutritional progress

  April 2023

• Record the use of Enterohormones

  April 2023

• Describe the use, management of HPN, and its related complications

  April 2023

• Describe the surgical procedures, used, timing, outcomes and complications

  April 2023

Study Arms (2)

Adults

Patients of 18 or more years old

Other: no interventions

Pediatrics

Patients less than 18 years old

Other: no interventions

Interventions

no interventions OTHER

no interventions

Adults; Pediatrics

Eligibility Criteria

• Age: 1 Week - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the SIC prevalence calculations, we aim to include 150 patients. The inclusion of patients will be done at the national level, considering as reference centers those hospitals that have Nutritional Support and Intestinal Rehabilitation Units, both public and private. Researchers may consecutively include all patients who give their consent and meet the selection criteria.

You may qualify if:

• Patients of both sexes, diagnosed with Type III intestinal failure (FI) due to SIC
• Signature of informed consent and assent as appropriate
• or more consecutive weeks of PN need

You may not qualify if:

• Less than 8 weeks of need for PN after diagnosis of SIC / FI
• Refusal to provide informed consent and assent as appropriate
• FI type I and II, and type III without SIC

Sponsors & Collaborators

• La Fundacion Favaloro para la Investigacion y la Docencia Medica: lead
• Fundación de Ciencias Exactas - UNLP: collaborator

Study Sites (1)

University Hospital of the Favaloro Foundation

Buenos Aires, C1093AAS, Argentina

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriel Gondolesi, Doctor

  University Hospital of the Favaloro Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: July 26, 2021
• Study Start: June 1, 2017
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)