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Obesity, Morbid clinical trials

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NCT ID: NCT01040533 Completed - Clinical trials for Protein Malnutrition

Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass

JIB-to-RYGB
Start date: December 2008
Phase: N/A
Study type: Observational

This study objectives are the following. - To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB). - To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss. - To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.

NCT ID: NCT01040507 Completed - Clinical trials for Clinically Severe Obesity

Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

>10yrsRYGB
Start date: June 2009
Phase: N/A
Study type: Observational

The main aim of this study is to analyze and report the very long-term outcomes after primary laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.

NCT ID: NCT01040481 Completed - Clinical trials for Clinically Severe Obesity

Adding Malabsorption for Failed Gastric Bypass

Start date: August 2009
Phase: N/A
Study type: Observational

The main aim of this study is to analyze and report the preliminary and intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL; 2) Trend in Comorbidity status; and 3) Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized, non-validated subjective satisfaction questionnaire and the validated, disease-specific, Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity & Mortality including nutritional status and metabolic complications. Consequently, secondary objectives of this study are 1) to assess failure rate defined as percentage of excess weight loss < 50% , lowest BMI >35 for morbidly obese (MO) or >40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessing preliminary and intermediate results after the surgery under analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters. This research is in line with the most current provocative new ideas and recent high impact publications. To the best of our knowledge, this is the very first outcome study of revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass. Previously, several studies have addressed conversion to malabsorptive gastric bypass after a failed primary proximal gastric bypass but none has addressed the failed distal gastric bypass nor the adequate balance between increasing restriction and malabsorption for decreasing the risk of protein-calorie malnutrition.

NCT ID: NCT01040377 Completed - Clinical trials for Inadequate Initial Weight Loss

Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

IIWL
Start date: October 2009
Phase: N/A
Study type: Observational

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.

NCT ID: NCT01039077 Completed - Morbid Obesity Clinical Trials

Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Start date: December 2009
Phase: N/A
Study type: Interventional

Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.

NCT ID: NCT01026181 Completed - Morbid Obesity Clinical Trials

Gastric Procedures for Obesity

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

This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.

NCT ID: NCT01025076 Completed - Morbid Obesity Clinical Trials

Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma

Start date: February 2009
Phase: Phase 2
Study type: Interventional

Executive Summary Aims and Hypotheses of the Study: The aim of the study will be to evaluate the safety, effectiveness and early outcome of the StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric patients. The study will test a hypothesis that the StomaphyX procedure will be effective in promoting the loss of regained weight, reducing the risk for comorbidities and improving patients' quality of life. Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20 Inclusion Criteria: 18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss. Exclusion Criteria: Esophageal stricture, or any anatomic conditions that preclude passage of transoral endoluminal instruments, has another causal factor for weight regain other than stoma or pouch dilatation, portal hypertension, coagulation disorders or chronic use of anticoagulants, any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk to the patient. Intervention Treatment: Creation of multiple full-thickness plications within the gastric pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA) Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL, uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay

NCT ID: NCT01007955 Completed - Insulin Resistance Clinical Trials

Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery

Start date: November 2006
Phase: N/A
Study type: Observational

The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease. Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.

NCT ID: NCT01002729 Completed - Morbid Obesity Clinical Trials

Oseltamivir Pharmacokinetics in Morbid Obesity

OPTIMO
Start date: November 2009
Phase: N/A
Study type: Interventional

This trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given to people who have influenza, and currently is also being used to fight the new H1N1 influenza. Some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. No studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half of the people will be of normal body weight and the others will be of a much higher than normal body weight. Using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.

NCT ID: NCT00999661 Completed - Morbid Obesity Clinical Trials

A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C

Start date: November 2009
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.