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Obesity, Morbid clinical trials

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NCT ID: NCT02167477 Withdrawn - Clinical trials for BARIATRIC SURGERY CANDIDATE

Comparison of Indirect and Direct Laryngoscopy in Obese Patients

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

An anaesthetist inserts a "laryngoscope" into the mouth to see the voice-box (larynx) for "tracheal intubation", when a tube is advanced into the windpipe (trachea) to protect the airway and administer anaesthetic gases. This study aims to compare traditional (direct view) Macintosh (MAC) laryngoscopy with Storz C-MAC videolaryngoscopes in subjects presenting for obesity reduction surgery using a novel "photographic overlay technique" to analyse the basis for any differences.

NCT ID: NCT02078934 Withdrawn - Weight Loss Clinical Trials

Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair

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

Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost 400,000 ventral hernia repairs annually in the United States. There is an even higher incidence of incisional hernia recurrence after prior repair if the patient is obese. Each subsequent hernia repair leads to increased morbidity and durability. It is not infrequent that many surgeons will advise overweight or obese patients to lose substantial weight prior to complex incisional hernia repair. However, it is quite difficult for any individual to lose more than 8 pounds a month in a safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet and exercise alone. Many patients with incisional hernia are physically debilitated that they cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction. - Novel minimally invasive endoscopic technique may help obese patients with an incisional hernia lose weight in a safe and rapid fashion. Early case reports and small case series on gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight loss. Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11 The intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are: - Feasibility of endoscopic gastric sleeve plication - Define the technical aspects of endoscopic suturing for sleeve plication - Provide long-term follow-up for both weight loss and resolution of their co-morbidities - Time from the endoscopic procedure to their incisional hernia repair - Photographic evidence of the stomach after endoscopic plication during the incisional hernia repair There are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14 The implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.

NCT ID: NCT01929850 Withdrawn - Morbid Obesity Clinical Trials

Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs. Weight Watchers Alone in Underserved Minority Women

Start date: n/a
Phase: Phase 4
Study type: Interventional

Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines as greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. Chronic underemployment, poor housing, child abuse, limited education, stress and anxiety are all associated with maternal morbid obesity. These latter conditions leave many patients in a state of economic, social and emotional poverty with need for life-long welfare support. For patients with true morbid obesity a standard surgical procedure is currently the procedure of choice especially among patients who fail standard medical intervention. The major procedures performed for morbid obesity include the Roux-en-Y gastric bypass, sleeve gastrectomy and laparoscopic band procedure. The sleeve gastrectomy is purely a restrictive procedure without malabsorptive components which involves one single staple line and can be performed laparoscopically in less than one hour. While these surgical procedures are recognized as "standard" procedures for patient who have failed medical treatment and are "covered" by most health plans, access to these procedures is limited for the medically underserved, rural, poor or underrepresented minorities since national, state and municipal health plans either provide minimal coverage or no coverage at all for surgery for morbid obesity. Reimbursement to providers offering these procedures is minimal and thus access to bariatric surgery is unlikely within a timely fashion.

NCT ID: NCT01686919 Withdrawn - Obesity, Morbid Clinical Trials

Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

Start date: December 2012
Phase: N/A
Study type: Interventional

Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and complications who opt for "gastric bypass" surgery, go through a standard program including a thorough clinical examination and information on the operation, followed by a learning and coping program that consists of standard dietary advise for weight loss and includes weekly visits during 8 weeks. This research project concerns a subgroup in the patient population described above: morbidly obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is known that milk may cause stomach complaints and may make it more difficult to loose weight.

NCT ID: NCT01063959 Withdrawn - Morbid Obesity Clinical Trials

Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. This is a retrospective chart review of intervention charts.

NCT ID: NCT01057784 Withdrawn - Morbid Obesity Clinical Trials

Bariatric Surgery Outcomes

Start date: March 2010
Phase: N/A
Study type: Observational

The UCLA Metabolic and Bariatric Surgery Program (adult program) and the UCLA Fit for Healthy Weight Program (adolescent program) are committed to the care of morbidly obese patients. This study is observational. The investigators plan to evaluate bariatric surgery outcomes using the BAROS National Database and also to evaluate quality of life pre- and post bariatric surgery. In addition, the investigators plan to enroll a subgroup of 10 reproductive-age women to evaluate: 1) pregnancy and offspring health, 2) long-term nutrition, 3) biomarkers/epigenome, and 4) body-composition/bone-density.

NCT ID: NCT01041534 Withdrawn - Morbid Obesity Clinical Trials

Adjustable Gastric Band Survey Study

AGB
Start date: July 2009
Phase:
Study type: Observational

Our aim is to complete a survey study of patients who have undergone Adjustable Gastric Band (AGB) surgery at the University of Washington Medical Center (UWMC) and expanded to other bariatric surgical sites outside the University of Washington (UW), which will obtain a HIPAA waiver and a letter of cooperation) between April 1, 2007 and July 1, 2008. (Please note the University of Washington team will not have access to the site's list of patients, only access to coded returned surveys sent back from patients). Patients will be identified by obtaining operative case lists from the Department of Surgery Quality Improvement Team who maintain monthly records of bariatric procedures performed. We will obtain patient contact information (address) and patients will be contacted by mail with the request that they complete both the Adjustable Gastric Band (AGB) Health Survey and a standard Quality of Life survey (EQ5D). The mailing will include an Information Statement, the AGB Survey, the EQ5D, and a stamped return envelope. As an incentive, a $2 bill will be sent along with the first mailing to cover the costs of completing and returning the surveys. Patients who do not return survey within 30 days will be mailed a second survey. Patients who do not return the second survey within 30 days will be mailed a third survey. Patients who do not return the third survey will not be re-contacted.

NCT ID: NCT00558532 Withdrawn - Clinical trials for Cardiovascular Disease

Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

Start date: October 2007
Phase: N/A
Study type: Observational

The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future studies.

NCT ID: NCT00534339 Withdrawn - Morbid Obesity Clinical Trials

EasyBand GOAL Trial

Start date: December 2010
Phase: N/A
Study type: Interventional

Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.

NCT ID: NCT00361985 Withdrawn - Morbid Obesity Clinical Trials

Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric bypass surgery for morbid obesity.