Metabolic Changes After Bariatric Surgery
Ključne riječi
Sažetak
Opis
Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone metabolism. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. Because restrictive procedures such as LSG do not involve bypassing segments of small bowel where micronutrient absorption takes place, fewer metabolic disturbances are expected than with other surgical techniques.
The observed changes in bone metabolism and status in post-bariatric surgery patients potentially involve several mechanisms, including reduced absorption of essential nutrients, diminished calcium absorption leading to secondary hyperparathyroidism, poor vitamin D absorption and restricted energy delivery. In addition, body weight protects against osteoporosis via the bone-strengthening effects of long-term weight bearing. However, long-term decreases in bone mineral density in patients who have undergone successful bariatric surgery are an unexpected, negative effect of this type of therapy.
In the study, parameters of fat and bone tissue and body composition changes are assessed in groups of bariatric patients after LSG, gastric plication and intragastric balloon treatment. Other anticipated benefits of the study treatment include improving the quality of life of. lt will also lead to the introduction of new processes, materials and methods. lt is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the Faculty of Medicine, University of Ostrava.
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 quality of Life Examination 3 months postoperatively
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 6 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 12 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life
Statistical data processing for statistical evaluation descriptive statistics are 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.
Datumi
| Posljednja provjera: | 02/28/2018 |
| Prvo podneseno: | 02/23/2016 |
| Predviđena prijava predata: | 09/01/2016 |
| Prvo objavljeno: | 09/08/2016 |
| Zadnje ažuriranje poslato: | 03/21/2018 |
| Posljednje ažuriranje objavljeno: | 03/25/2018 |
| Stvarni datum početka studija: | 02/29/2012 |
| Procijenjeni datum primarnog završetka: | 09/30/2017 |
| Predviđeni datum završetka studije: | 11/30/2017 |
Stanje ili bolest
Intervencija / liječenje
Procedure: Laparoscopic sleeve gastrectomy
Procedure: Laparoscopic gastric plication
Procedure: Intragastric balloon
Device: Intragastric balloon
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Active Comparator: Laparoscopic sleeve gastrectomy Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy. | Procedure: Laparoscopic sleeve gastrectomy Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat. |
| Active Comparator: Laparoscopic gastric plication Patients undergoing bariatric surgery procedure of laparoscopic gastric plication. | Procedure: Laparoscopic gastric plication Laparoscopic gastric plication involves sewing one or more large folds in the stomach. During the laparoscopic gastric plication, the stomach volume is reduced about 70%, which makes the stomach able to hold less and helps the patient eat less. |
| Active Comparator: Intragastric balloon Patients undergoing bariatric surgery procedure with intragastric balloon implantation. | Procedure: Intragastric balloon The introduction of the balloon is non-invasive as it is inserted endoscopically (down the oesophagus). The balloon is then filled inside the stomach with a dyed physiological solution, which reduces the volume of the stomach. |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 20 Years To 20 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: - History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities) Exclusion Criteria: - Thyroid disease - Diseases of the digestive system associated with disorders of intestinal absorption - History of corticosteroid therapy in the past 12 months |
Ishod
Primarne mjere ishoda
1. Changes in serum levels of adipose tissue hormones [18 months]
2. Changes in serum levels of lipids [18 months]
3. Changes in serum levels of osteomarkers [18 months]
4. IWQOL Questionnaire evaluation [18 months]
5. SF-36 Questionnaire evaluation [18 months]
Sekundarne mjere ishoda
1. Long-term weight reduction assessment in kgs [18 months]
2. Effectiveness evaluation [18 months]
