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Morbid Obesity clinical trials

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NCT ID: NCT04243564 Withdrawn - Morbid Obesity Clinical Trials

Laryngeal Mask in Morbid Obesity

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients

NCT ID: NCT04207424 Withdrawn - Morbid Obesity Clinical Trials

Embolization of Arterial Gastric Supply in Obesity

Embargo
Start date: April 2021
Phase: N/A
Study type: Interventional

This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.

NCT ID: NCT04170335 Withdrawn - Breast Cancer Clinical Trials

Effects of Bariatric Surgery on Breast Density Improvement and Impact on Breast Cancer Risk in Severe Obese Patients

Start date: February 22, 2021
Phase:
Study type: Observational

Breast cancer is the most common cancer in women in the US, and obese women have a 20% to 40% increase in the risk of developing breast cancer compared with normal-weight women. Bariatric surgery is now considered the first line option for weight loss management in morbidly obese patients with failure of medical treatment. There is strong evidence that in early stages of cancer the breast undergoes inflammatory and subsequently density changes that are observable in mammography. The aforementioned alterations have been suggested to be magnified by obesity, potentially due to its pro-inflammatory state. The investigators hypothesized that rapid weight loss following bariatric surgery and henceforth the reduction of inflammatory stress in the breast tissue could potentially have a positive effect in improving breast density and consequently, reducing the risk of breast cancer. In this order of ideas, with this study, the investigators aim to evaluate how breast density is modified after bariatric surgery, and how it impacts the risk of developing breast cancer using The Breast Cancer Surveillance Consortium (BCSC) risk score and calculator in our population.

NCT ID: NCT03159130 Withdrawn - Morbid Obesity Clinical Trials

OnQ Pain Pump Effectiveness in Post Operative Pain Control in Bariatric Patients

Start date: June 2012
Phase: N/A
Study type: Observational

This study will assess the efficacy of OnQ pain catheters in pain reduction in the bariatric surgical population and seeks to identify if a quantifiable improved post-operative course occurs in patients receiving a catheter filled with local anesthetic versus that achieved by patients who receive a catheter filled with injectable saline.

NCT ID: NCT02476474 Withdrawn - Morbid Obesity Clinical Trials

GERD Following Laparoscopic Sleeve Gastrectomy

Start date: July 2023
Phase: N/A
Study type: Interventional

Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve resection in each center, this can result in difference of the remaining gastric antrum which may affect gastric emptying time after this procedure.

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: 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.