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Bariatric Surgery clinical trials

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NCT ID: NCT02648191 Terminated - Obesity Clinical Trials

Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery

OBESITE
Start date: March 2, 2016
Phase: N/A
Study type: Interventional

Faced with the current obesity epidemic, new avenues of research into effective weight loss must be developed. Among the possible actions on obesity, vagus nerve stimulation has been shown in several studies to be effective in treating epilepsy or depression, at the same time inducing weight loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss in experimental animal studies. Vagus nerve stimulation has never been attempted in obese patients awaiting bariatric surgery.

NCT ID: NCT02579798 Completed - Bariatric Surgery Clinical Trials

Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?

Start date: July 2013
Phase: N/A
Study type: Interventional

General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used. The functional residual capacity (FRC) of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis. Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important. There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined. The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery. The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient (arterial and end tidal gradient) between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy). The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.

NCT ID: NCT02577744 Recruiting - Obesity Clinical Trials

Acute Effect of EPAP and Noninvasive Ventilation on Pulmonary Function and Lung Regional Ventilation on Bariatric Surgery

Start date: October 2015
Phase: N/A
Study type: Interventional

Obesity is a non-communicable chronic disease of multifactorial, involving biological, historical, ecological, economic, social, cultural and political. Currently, bariatric surgery is considered an effective method of refractory obesity treatment, and only severe obesity effective treatment that leads to reduced long-term weight. It is well documented in the literature regarding the association of abdominal surgery and the incidence of respiratory complications and its main characteristics are: atelectasis, pneumonia, respiratory dysfunction and pleural effusion. All these respiratory complications can be minimized or avoided with the use of a respiratory therapy care protocol, since the pulmonary atelectasis is considered the main cause of complications. An arsenal of resources to physical therapy lung expansion, among these, the application of positive pressure through a valve EPAP (Expiratory positive airway Pressure) and the use of noninvasive ventilation, and aims to prevent and / or improve the complications resulting from postoperative. The electrical impedance tomography (EIT) is an alternate to allow assessment of the respiratory system, without suffering the same interference conditions of patients, such as pain and bed rest. TIE consists of a method that measures passively regional lung ventilation. The aim of this study is to compare the effects of the application of EPAP and NIV on pulmonary ventilation we post bariatric surgery. This is a randomized controlled trial where patients will be divided into two groups: EPAP and NIV and assessed by spirometry, manometer and TIE. The techniques will be applied in the 1st and 2nd postoperative day where they will be evaluated before, during and after the application of the techniques.

NCT ID: NCT02552433 Enrolling by invitation - Bariatric Surgery Clinical Trials

Complications in Body Contouring Surgery

CONTOUR
Start date: September 2015
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to describe the wound related complication rate in post-bariatric body contouring surgery patients who are treated according to the new Dutch guideline and to asses the factors associated with a higher complication rate.

NCT ID: NCT02525016 Completed - Obesity Clinical Trials

Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

SPIRAL
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery. Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use. Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe. Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient. Investigators get approbation of local ethic committee for this work.

NCT ID: NCT02440087 Completed - Obesity Clinical Trials

Evaluation of the Dietary Supplement Refill Bypass to Reduce Nutritional Deficiencies of Patients Who Underwent Bariatric Surgery

Refill
Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

This is a cohort, observational, prospective, multicenter, longitudinal study. 100 patients will be followed postoperatively for a period of 12 months. Intermediate statistical analyzes will be performed at 1 month, 3 months, 6 months and 9 months. This observational study is non-interventional, it does not change the usual care of patients who underwent a bariatric surgery. Data collection will be carried out during routine visits planned in the post-operation usual follow-up. The blood tests are part of the patient's usual care for his bariatric surgery. Surgeons will include patients for whom they have freely decided to use the dietary supplement Refill under the care of the treatment of obesity. The motivation of the patient and his commitment to the project is evaluated by the surgeon. The main objective is to evaluate the efficacy of the dietary supplement Refill. The primary endpoint is the reduction of iron deficiency.

NCT ID: NCT02431195 Completed - Obesity Clinical Trials

Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members

SOCIOB
Start date: March 2015
Phase:
Study type: Observational

The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.

NCT ID: NCT02406885 Completed - Obesity Clinical Trials

Apixaban Pharmacokinetics in Bariatric Patients (APB)

APB
Start date: July 19, 2017
Phase: Phase 4
Study type: Interventional

The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE) prophylaxis and treatment) in the obese adult population to determine if bariatric surgery influences apixaban exposure. More interesting would be to see how the dose may need to change pre- vs. post-bariatric surgery (this will be important for physicians as more and more patients undergo this procedure worldwide and many may require anticoagulation in their future healthcare). Physicians and surgeons are very interested in oral anticoagulants for this special patient population. To date, there is no approved dosing for the obese patient (especially when considering surgical intervention such as bariatric surgery). Primary outcome variable. To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or Roux-en-Y gastric bypass patients). Secondary outcome variables. 1. To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric surgical patients who have undergone RYGB vs. VSG. 2. To determine how the pharmacokinetics of the drug may differ when there is significant post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months following surgery versus those patients who have suboptimal weight loss following bariatric surgery (< 40% of estimated excess body weight).

NCT ID: NCT02381262 Completed - Obesity Clinical Trials

Fitbit / Healthy Weight Management Study

Start date: October 2015
Phase: N/A
Study type: Interventional

Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve gastrectomy surgery, the investigators would like to determine if the Fitbit is associated with health outcomes in this population. Primary Outcome • Percentage of excess weight loss - Does the use of a Fitbit positively affect the percentage of excess body weight loss in vertical sleeve gastrectomy patients? Secondary Outcomes - Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive lifestyle and exercise pattern changes in post-operative VSG patients? - Resolution of comorbidity - Does the use of a Fitbit positively affect patient health via reduction of co-morbid conditions associated with morbid obesity following VSG surgery?

NCT ID: NCT02380950 Completed - Bariatric Surgery Clinical Trials

Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass

Start date: June 2013
Phase: N/A
Study type: Interventional

Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol effects after gastric bypass we suggest that also general cognitive function is stronger impaired. Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8 normal weight subjects) in the study. Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".