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Bariatric Surgery Candidate clinical trials

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NCT ID: NCT04400136 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

PPI Therapy Impact on GERD After Sleeve Gastrectomy

Start date: July 1, 2020
Phase: Early Phase 1
Study type: Interventional

The trial would to try to establish: - The best post-operative PPI prescription protocol after Sleeve Gastrectomy - The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett) - The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ

NCT ID: NCT04343040 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients

PERISURG-CGM
Start date: September 2022
Phase: N/A
Study type: Interventional

The recent use of a pre-operative carbohydrate loading compared to fasting has been shown to improve the early recovery after surgical procedures by reducing the profound stress response following surgery and allowing a better postoperative blood glucose regulation by lowering insulin resistance. The responsible mechanisms of T2D remission after bariatric surgery are not completely understood and guidelines for the early management of T2D and GI following bariatric surgery are lacking, resulting in highly variable postoperative glucose control. No other study has yet investigated the effect of preoperative carbohydrate loading on glucose control the first days after the bariatric surgery in patients who have poor glycemic control

NCT ID: NCT04174495 Not yet recruiting - Obesity Clinical Trials

Bone Fragility Evaluation in Obese Patients

Start date: February 2020
Phase:
Study type: Observational

This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight loss after surgery and SBAC-L1), to improve the bone screening.

NCT ID: NCT04127370 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease

NCT ID: NCT04046367 Not yet recruiting - Obesity Clinical Trials

Prehabilitation in Bariatric Surgery

Start date: August 22, 2019
Phase: N/A
Study type: Interventional

Obesity is a major public health problem in our region and constitutes a priority of the Canary Islands Health Plan. Bariatric surgery is the most effective intervention in the treatment of obesity and its complications. However, people with obesity have high surgical risk and long-term outcomes are related to pre-surgical weight loss. In patients currently on the bariatric surgery waiting list, a randomized controlled trial will be performed in which two group interventions will be compared. One of the interventions (standard), will consist of educational modules in food and exercise, combined with cognitive-behavioral therapy. In the other, a specific training (prehabilitation) will be added to encourage physical activity and the conditioning of inspiratory muscles. The pre-surgical weight loss (principal outcome) will be compared between groups, as well as the evolution of the complications of obesity, the functional status of the patients, their physical activity, quality of life, immediate complications of surgery and days of admission.

NCT ID: NCT04035512 Not yet recruiting - Clinical trials for Bariatric Surgery Candidate

The Expressive Writing in Bariatric Surgery

EWinBSP
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed. The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.

NCT ID: NCT03864861 Not yet recruiting - Clinical trials for Postoperative Complications

Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

POWER3
Start date: October 22, 2019
Phase:
Study type: Observational

Methods National audit of a 90-day prospective observational cohort in which pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%) Research Places Spanish Hospitals where this surgical intervention is carried out. Objectives To determine the incidence of postoperative complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the hospital stay and postoperative complications including 30-day mortality. Sample size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a number of patients with complications of 11%, the sample size calculation yields 460 patients, although the final sample size it may be smaller depending on the proportion of complications detected. Inclusion criteria Patients older than 18 years who are going to be electively operated on for bariatric surgery regardless of their adherence to an ERAS intensified recovery program and the compliance level of the protocol (from 0-100%) Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.

NCT ID: NCT03301545 Not yet recruiting - Obesity Clinical Trials

The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly co-occur and are associated with significant morbidity, mortality, and health care expenditures. The Indigenous (First Nations, Metis and Inuit) population bears a disproportionate burden of T2DM in Canada. The prevalence of obesity among Indigenous individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In 2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as Indigenous. At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric surgery is an effective treatment modality for the improvement and resolution of T2DM in patients who are obese. We aim to compare the effectiveness of bariatric surgery with conventional medical treatment in treating metabolic diseases in Indigenous people; the findings of which will assist in future treatment and program planning. Our objective is to determine whether Manitoba's urban Indigenous population will achieve better diabetic control and improved rates of remission of T2DM with bariatric surgery compared to best diabetic medical care.

NCT ID: NCT03211455 Not yet recruiting - Morbid Obesity Clinical Trials

Intravenous Lidocaine in Bariatric Surgery.

XYLOBAR
Start date: August 1, 2017
Phase: Phase 3
Study type: Interventional

Although peroperative intravenous lidocaine has been shown to be useful in early recovery after colorectal surgery, its beneficial effect on the specific population of obese patients scheduled for bariatric surgery remained unknown. Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery