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Obesity, Morbid clinical trials

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NCT ID: NCT01759667 Completed - Obesity Clinical Trials

DIT After RYGB - A Prospective Study

DIT RYGB
Start date: August 2012
Phase: N/A
Study type: Interventional

Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese patients. This loss is a result of several factors that go beyond the simple anatomical abnormality of the gastrointestinal tract and may be the product of post-op energy expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are important components of energy expenditure and possible changes in them can perform an important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients, which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The objective of this study is to perform a prospective analysis of these same variables (RQ and DIT), evaluating them in the same patients, when pre and postoperatively.

NCT ID: NCT01759550 Terminated - Morbid Obesity Clinical Trials

Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip

Start date: September 2011
Phase:
Study type: Observational

The study is primarily to evaluate the safety and efficacy of the LigaSure Advance™ Pistol Grip and LigaSure™ Blunt Tip using the Force Triad™ Energy Platform during Roux-en-Y and gastric reduction procedures (sleeve gastrectomy or placation), respectively. Also, Economic value of using LigaSure in gastric surgeries will be appraised. In this prospective case series, 60 patients previously scheduled to undergo a Roux-en-Y or gastric reduction procedure (sleeve gastrectomy or placation) will have hemostasis controlled with LigaSure Advance ™ Pistol Grip or LigaSure™ Blunt Tip, respectively. All subjects undergoing Roux-en-Y or gastric reduction procedures (sleeve gastrectomy or placation) procedure at Durham Regional Hospital will be recruited. Data Analysis will be performed using the data collected in the software program titled MetaBar at Duke University Medical Center. Categorical variables will be summarized as proportions for each category; continuous measures will be summarized by mean and standard deviation or median and range as appropriated for the data distribution. Procedure-related risks are those typically associated with gastric procedures and general anesthesia including intra-operative bleeding, infection, and injury to surrounding organs and structures. Device related risks include those normally associated with the use of electrosurgery including intra-operative bleeding, unintended tissue burns, electrical shock, and electrical stimulation of muscles and nerves.

NCT ID: NCT01754194 Completed - Morbid Obesity Clinical Trials

Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery

OPTIMIZE
Start date: April 2012
Phase: N/A
Study type: Observational

Study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

NCT ID: NCT01748682 Completed - Morbid Obesity Clinical Trials

Very Low Calorie Liquid Diet for Pre op Patients

Start date: January 2011
Phase: N/A
Study type: Interventional

Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the reduction of comorbidities associated with surgical act, such as decreased visceral fat, liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to be employed in this period need to be defined more clearly. As there is no description of comparative studies on diet of normal consistency, using solids and liquids, there are doubts as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack of robust evidence has made nutrition professionals adopt different procedures. There is still a belief that these patients are unable to lose weight in the preoperative period, the ongoing history of previous attempts without success.

NCT ID: NCT01748513 Completed - Clinical trials for Anomaly; Venous Return

Volume-challenge in Morbid Obesity

Start date: March 2011
Phase: N/A
Study type: Observational

Preoperative venous return stability and euvolemia is essential in management of morbidly obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on preoperative management, are rare and not in consensus.The aim of this study was to evaluate preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on hemodynamics, stroke volume and level of venous return to the heart.

NCT ID: NCT01724983 Active, not recruiting - Morbid Obesity Clinical Trials

Ketamine in Bariatric Surgery

Start date: June 2012
Phase: Phase 3
Study type: Interventional

Ketamine may improve recovery from bariatric surgery.

NCT ID: NCT01724970 Recruiting - Morbid Obesity Clinical Trials

Laryngeal Masks for Bariatric Surgery

Start date: July 2012
Phase: Phase 3
Study type: Interventional

Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

NCT ID: NCT01707771 Completed - Morbid Obesity Clinical Trials

Bariatric Surgery and HDL-cholesterol

Start date: September 2008
Phase: N/A
Study type: Interventional

Objective: to assess the effect of gastric bypass on HDL-cholesterol concentration and its Apolipoprotein A4 content at 1 year following bariatric surgery in comparison with a hypocaloric diet. Secondary aim was to measure total cholesterol and triglycerides levels as well as insulin sensitivity after interventions. Summary Background Data: Very few prospective uncontrolled studies have investigated the effects of Roux-en-Y gastric bypass (RYGB) on cardiovascular risk factors. No controlled studies had as primary goal the changes in HDL-cholesterol after gastric bypass. Methods: Forty subjects with a BMI>40 or ≥35 kg/m2 in the presence of diabetes were enrolled. Twenty of them were operated of RYGB while 20 received lifestyle modification suggestions and medical therapy for obesity complications (diabetes, hypertension and hyperlipidemia).

NCT ID: NCT01703546 Completed - Morbid Obesity Clinical Trials

Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

Start date: November 2011
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

NCT ID: NCT01700738 Not yet recruiting - Obesity Clinical Trials

Evaluation of the Effects of Laying Early a Gastric Band on the Prevention of Morbid Obesity Randomized Checked Against Standard Management of Obesity in This Population.

CHADO
Start date: November 2012
Phase: Phase 4
Study type: Interventional

MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity. SECONDARY OBJECTIVES - Compare the effects of the placement of a gastric band with "conventional" treatment of obesity on quality of life, body composition and parameters of the metabolic syndrome. - Identify predictors of "good answer to the ring" to determine the best future indications. - Study of the gastric tolerance. INCLUSION CRITERIA 1. Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg 2. Obesity "common" non-syndromic. 3. Medical decision of surgical placement of laparoscopic gastric banding. 4. Adolescent and family who understand and accept the need for medical and surgical follow long term. 5. Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up. 6. Obtention of oral and written consent of the adolescent and the parents. 7. Parents and adolescents affiliated with the social security system. NONINCLUSION CRITERIA 1. Intellectual Deficit. 2. psychiatrics contraindication of surgical placement of laparoscopic gastric banding. 3. Obesity with severe binge eating. 4. Pregnancy or wishes of pregnancy in the following year. 5. Non accession adolescent and / or family in the process of medical care before inclusion. 6. Predictable post surgical monitoring difficulties. 7. Suspicion of physical abuse, verbal or negligence / deficiency in care of the family. 8. Participation in a clinical study evaluating a treatment during the 2 years of the study. EXCLUSION CRITERIA 1. Anesthetic contre indication for placement of a gastric laparoscopic. 2. IMC> 50 kg/m2 the day of inclusion. STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient and his family. Patients will then be enrolled and randomized. Patients in group A (surgery group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in group B start conventional monitoring dietary medical and physical. For both groups follow-up visits will occur every 3 months for 2 years.