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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT06061406 Active, not recruiting - Obesity Clinical Trials

BE Smart - Bariatric Patient - Empowerment in the Preparation and Follow-up of Bariatric Surgery Using the Smartvisit App (BESmart)

BESmart
Start date: May 2, 2021
Phase: N/A
Study type: Interventional

Obesity affects an increasing proportion of the population and is associated with numerous comorbidities that cause increased morbidity and mortality. The most effective therapy for morbid obesity is metabolic bariatric surgery. Surgical numbers are increasing worldwide. Before surgery, patients must try to reduce weight conservatively in a multimodal therapy concept. In addition, numerous protocols must be collected and appointments must be organized. Postoperatively, patients are expected to receive lifelong follow-up care, which increasingly overwhelms bariatric centers. People with overweight and obesity ° I are often left largely alone with the treatment of their disease. There is a considerable gap in care here. For the care of patients with obesity and empowerment in dealing with their disease, the smart visit app from the company aycan, which is adapted to obesity patients, is to be investigated. This is designed as a pilot project with the primary endpoint of usage and satisfaction (after 3 months, key secondary endpoint after 12 months). A total of 100 patients from 3 groups (postoperative, preoperative, permanent conservative with only overweight/obesity °I) will use the app for 1 year for this purpose.

NCT ID: NCT05992662 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Minfulness-Based Training Program in Bariatric Surgery Patients

Start date: August 2, 2022
Phase: N/A
Study type: Interventional

Bariatric surgery maintains its place in the literature as the most effective treatment method for obesity. In order for the surgery to be effective, it is important for individuals to adapt to the surgical process. This process has become more manageable with lifestyle changes and health education. Mindfulness practices are (useful forms of intervention) for practicing and restructuring the brain for healthier eating habits. The results of mindfulness studies show that mindful eating practices can be effective in the prevention and treatment of obesity. Studies on mindfulness in obesity are increasing rapidly in the literature; however, few studies have tested this approach in bariatric surgery patients. This research was planned in an action research design to examine the effect of mindfulness-based education program on individuals' mindful eating in bariatric surgery patients. As an action in the research, an mindfullness-based training program will be developed for the bariatric patient group. Then, in the preoperative period, a four-week, weekly session of mindfulness-based exercise and eating training will be given to the action group as an intervention. Mindful Eating Questionnaire will be applied to all participants (action and control group) before the training, and data will be collected from the action group with the vignette technique. A short cut story will be prepared, and the participants will be asked to complete the short story in written form. At the end of the training sessions, a focus group discussion will be held with the participants. An in-depth interview will be conducted with each participant in line with the semi-structured interview form in the third and sixth months after the surgery. The Mindful Eating Questionnaire will be readministered to both the action group and the control group. During and after the training, participants will be asked to write down any changes they notice in their diaries. In the research, quantitative data will be evaluated with descriptive statistical tests, and qualitative data will be evaluated with content analysis, descriptive and thematic analysis. As a result of the research, it is aimed to improve the mindful eating of the participants. It is anticipated that the research will increase the mindfulness level of the participants in their lives and contribute to future research.

NCT ID: NCT05843812 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Magnesium Sulfate in Bariatric Surgery

MgSObs
Start date: April 21, 2023
Phase:
Study type: Observational

Weight loss surgery, also known as bariatric surgery, has been around since the 1950s and since its inception has been shown to successfully achieve significant and sustainable weight loss in a large number of patients who undergo this intervention, as well , if a beneficial impact is observed in the management of metabolic disorders, such as type 2 diabetes mellitus and hyperlipidemia. After bariatric surgery, patients are at risk of narcotic-related side effects.(2) Because of this, pain management strategies must be implemented to reduce the consumption of narcotic medications. Some studies have reported that a multimodal analgesic regimen can reduce the consumption of postoperative narcotics, as well as the therapy requirements to control postoperative nausea and vomiting. It has also been reported that excess body mass is associated with changes in mineral levels in the body, particularly hypomagnesemia , a condition that is also common in hospitalized patients (Hansen & Bruserud 2018), and has a high incidence in the perioperative environment. Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure. It is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, which is why it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue injury. In addition, other relevant clinical effects of MgSO4 have been reported in anesthesiology, such as its effect as a CNS depressant, modulation of the hemodynamic response, reduction of the intraoperative requirements of anesthetics, analgesics, and muscle relaxants. As well as the potentiation of the effect of non-depolarizing muscle relaxants. The role of magnesium in the body and its pharmacological properties continue to be studied and knowledge of its pharmacological, clinical and physiological characteristics has become essential for the anesthesiologist. There are no previous studies that allow establishing an optimal therapeutic scheme considering all the perioperative clinical effects of MgSO4 and that evaluate the role of genetic variability in pain perception and response to treatment in bariatric surgery.

NCT ID: NCT05798702 Active, not recruiting - Weight Loss Clinical Trials

Fibrosis Reduction in Non Alcoholic Steatohepatitis

FRIN
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Background: Non-Alcoholic Steatohepatitis (NASH) represents one of the stages of Non-Alcoholic Fatty Liver Disease (NAFLD) with a very high risk to evolve in cirrhosis and hepato-carcinoma. Currently, the only diagnostic method is a liver biopsy that remains the gold standard for characterizing liver histologic alterations and fibrosis stages. There is no specific treatment for NASH, in fact no drugs are currently licensed specifically for treating this disease. Aim: Our aim is to conduct a non-inferiority, randomized-controlled trial (RCT) comparing Roux-en-Y Gastric bypass (RYGB) with an intensive lifestyle modification plan (Very low-calorie diet, VLCD) for the reduction of advanced stages of fibrosis in subjects with obesity and NASH after 25% weight loss.

NCT ID: NCT05428059 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Obesity, which is the second leading cause of preventable death in the world, affects all the systems in the body and affects many physiological problems, as well as the mental state, body image and quality of life of the individual. For this reason, obese individuals try various treatment methods in order to get rid of obesity, and in cases where these methods fail, they often prefer bariatric surgery. It is very important that patients who will undergo bariatric surgery can adapt to the anatomical changes in their body and shape their lifestyle accordingly. Otherwise, it is inevitable for patients to face various complications after surgery. After bariatric surgery, a structured training program in the preoperative period is of great importance in order for the patient to adapt to the changes in his body, to prevent the development of possible complications, to be affected by the negativities that may occur due to the current change, and to prepare for the new lifestyle. In this context, the main subject of this research is to enable individuals to gain healthy lifestyle behaviors by providing mobile-based training and consultancy services that enable them to easily access the right information at the desired time and place.

NCT ID: NCT04851470 Active, not recruiting - Obesity Clinical Trials

Periodontal Assessment of a Bariatric Care Population

Bariatric
Start date: January 31, 2014
Phase:
Study type: Observational

Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients. Our secondary objectives are to: Investigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients. Investigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population. Investigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.

NCT ID: NCT04847037 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Place of Connected Tools in Bariatric Patients Follow-up.

Start date: March 5, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS).

NCT ID: NCT04583683 Active, not recruiting - Obesity Clinical Trials

Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities

ARGOS
Start date: September 30, 2020
Phase: N/A
Study type: Interventional

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

NCT ID: NCT04506190 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Prospective Robotic-assisted Revisional Bariatric Study

Start date: November 1, 2020
Phase:
Study type: Observational

Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.

NCT ID: NCT04469712 Active, not recruiting - Metabolic Syndrome Clinical Trials

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.