Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-10-01
2023-12-31
Brief Summary
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Detailed Description
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Current state of knowledge:
Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Group with adjustable IGB
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
Group with nin-adjustable IGB
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
Interventions
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bariatric endoscopy, mainly intragastric baloons, plication of stomach too
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
Eligibility Criteria
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Inclusion Criteria
2. BMI \>30 Kg/m2
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment , endoscopy, radiography, as well as laboratory investigations.
4. Must be able to understand and be willing to provide written informed consent.
Exclusion Criteria
1. Achalasia and any other esophageal motility disorders
2. Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
3. Hypertension: uncontrolled hypertension during last 3 month
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GIT stenosis or obstruction
6. Pregnancy or breastfeeding
7. Impending gastric surgery 60 days post intervention;
8. Currently participating in other study
9. Celiac disease
10. History of bariatric surgery
11. Chronic or recent acute pancreatitis
12. Type 2 diabetes with insuline medication or type 1 diabetes
13. Hematologic disease or disease with impairment of hemocoagulation
14. Decompensated psychiatric disease
15. Autoimmune disease with chronic glucocorticoid or imunosupressive medications
16. Uncontroled disease of thyroid gland
17. Excesive abuse of addictive substances such alcohol or other
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Olomouc
OTHER
University Hospital Ostrava
OTHER
Palacky University
OTHER
University of Ostrava
OTHER
Responsible Party
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Principal Investigators
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Adam Vasura, MD
Role: STUDY_CHAIR
- Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
Evzen Machytka
Role: STUDY_CHAIR
Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
Locations
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Department of gastroenterology, hepatology and pancreatology
Ostrava, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Adam Vasura
Role: primary
References
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Fakhry TK, Mhaskar R, Schwitalla T, Muradova E, Gonzalvo JP, Murr MM. Bariatric surgery improves nonalcoholic fatty liver disease: a contemporary systematic review and meta-analysis. Surg Obes Relat Dis. 2019 Mar;15(3):502-511. doi: 10.1016/j.soard.2018.12.002. Epub 2018 Dec 6.
Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct;21(10):1499-507. doi: 10.1007/s11695-011-0424-z.
Leoni S, Tovoli F, Napoli L, Serio I, Ferri S, Bolondi L. Current guidelines for the management of non-alcoholic fatty liver disease: A systematic review with comparative analysis. World J Gastroenterol. 2018 Aug 14;24(30):3361-3373. doi: 10.3748/wjg.v24.i30.3361.
Other Identifiers
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08_RVO-FNOs_2020
Identifier Type: -
Identifier Source: org_study_id