Multicenter Prospective Observational and Epidemiological Registry for Patients With Intestinal Failure Due to Short Bowel Syndrome, in Latin America
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Describe the long term outcome of Type III-IF patients with short bowel syndrome in Latinoamérica.
研究概览
简要总结
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.
详细描述
RESTORE amedment 1project, obtained the study number DDI (1384) 1317 from the Institutional Research and Ethics committee after its approving the choices of participating centers by RESTORE's Scientific Steering Committee. For participation, those centers needed a full-time or part-time surgeon-though not necessarily offing rehabilitation surgery or transplantation or accessing enterohormone (EH) therapies-a therapist with nutritional experience, a dietitian, and specialized pharmaceutical resources. Participating teams, however, did not necessarily have to offer rehabilitation surgery or transplantation capabilities or have access to EH therapies to be elected for participation.
RESTORE's aim was assessing the long-term outcomes of SBS pts with IF, under the current standard of care in order to plumb IF's natural history, the indications for currently available therapies, and their means of modifying each course.
Study Designed: the first prospective, observational, epidemiological, multicenter study in Argentina of adult pts with SBS-caused type-III IF in Lat-America.
In adults, the inclusion of additional centers in Argentina, Mexico, Colombia, Peru, Uruguay and Chile will be required. In pediatric patients, it is proposed to add patients and centers in Argentina and, if necessary, in other Latin American countries (Mexico, Colombia, Peru, Chile and Uruguay).
Number of patients and centers:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Week 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, diagnosed with Type III intestinal failure (FI) due to SIC
- •Signature of informed consent and assent as appropriate
- •8 or more consecutive weeks of PN need
排除标准
- •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
结局指标
主要结局
Describe the long term outcome of Type III-IF patients with short bowel syndrome in Latinoamérica.
时间窗: April 2023
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).
次要结局
- 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)
- Time to obtain therapy access(April 2023)
- Assess the quality of life(April 2023)
- Describe the surgical procedures, used, timing, outcomes and complications(April 2023)
研究者
Prof. Dr. Gabriel E. Gondolesi
Doctor
La Fundacion Favaloro para la Investigacion y la Docencia Medica