Aspiration Therapy for Obese Adolescents

Obesity, Morbid Clinical Trial

Official title: Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents

Status Completed

Clinical Trial Summary

Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age.

The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.

Clinical Trial Description

The aim of the project is the testing and research of the impact on metabolism using the approved bariatric method AspireAssist, which is currently used in the adult population. The method has been approved by FDA since 2016. The method involves the introduction of percutaneous endoscopic gastrostomy (PEG) that allows the aspiration of a portion of the food and the control of the size and volume of the food received, even in the unmanaged size and volume of food intake.

Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava a.s. In addition to a pediatric and internal examination, a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis, and will further assess the degree of patient support and co-operation. Selected participants in the study or their family members will receive informed consent. A study participant is considered to be a participant in the study after consent to his / her inclusion in the study after the informed consent has been signed. The AspireAssist aspiration device is the definitive participation in the study.

Two parts will be monitored within the project. (1) Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion, especially in surgical methods. (2) The second objective is to monitor the saccharide and lipid metabolism, GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied.

The patients enrolled in the study are followed for the period of twelve months.

Timetable of the study procedures and controls:

Preoperative examination:

• Demographic data on age, sex, weight, height, smoking

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life Examination 3 months postoperatively

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life Examination 6 months after surgery

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life Examination 12 months after surgery

• Assessment of body composition and sampling of blood

• Questionnaires for the quality of Life

Statistical data processing for statistical evaluation descriptive statistics is used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection. ;

Related Conditions & MeSH terms

• Obesity, Morbid

• NCT number: NCT03598920
• Study type: Observational
• Source: University Hospital Ostrava
• Status: Completed
• Start date: August 1, 2018
• Completion date: December 31, 2021