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Obesity, Morbid clinical trials

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NCT ID: NCT04364841 Completed - Obesity, Morbid Clinical Trials

Body Image and Sexuality After Bariatric Surgery

Start date: June 1, 2017
Phase:
Study type: Observational [Patient Registry]

Sexual desire may decrease among obese individuals who feel worthless and therefore there may be behaviors that avoid sexuality. Sexuality, one of the activities of daily life, is an issue that is affected by cultural norms and rules and individuals have difficulties expressing their sexual problems comfortably. In a systematic review which is about the effect of bariatric surgery on sexuality; it was emphasized that bariatric surgery, the most widely used treatment in obesity, has positive effects upon reproductive hormones and sexual functions thanks to weight loss. In light of these information above-mentioned; the study was done to examine the correlation between body perception and sexual life before and after bariatric surgery among obese individuals.

NCT ID: NCT04354532 Completed - Surgery Clinical Trials

Laparoscopic Banded Sleeve Gastrectomy

Start date: February 1, 2014
Phase:
Study type: Observational

Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The Investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.

NCT ID: NCT04333979 Completed - Obesity, Morbid Clinical Trials

The Effect of Drain Use on Patient Comfort in Laparoscopic Sleeve Gastrectomy

Start date: December 9, 2016
Phase: N/A
Study type: Interventional

Introduction Laparoscopic sleeve gastrectomy surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

NCT ID: NCT04235829 Completed - Hypertension Clinical Trials

Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes

Start date: April 1, 2012
Phase:
Study type: Observational [Patient Registry]

A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.

NCT ID: NCT04228185 Completed - Obesity, Morbid Clinical Trials

Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

Start date: January 2014
Phase: N/A
Study type: Interventional

Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term. The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term. Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years. Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.

NCT ID: NCT04197336 Completed - Obesity Clinical Trials

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

BAE2
Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Obesity is defined as a body mass index (BMI) ≥30 kg/m2 and with a subclass of obesity known as morbid or severe obesity (BMI of ≥40 kg/m2). These are major issues in medicine for both participants and medical providers with >36% of the US population affected. Obesity is one of the biggest causes of preventable chronic diseases and healthcare costs in the USA. Obese adults spend 42% more on direct healthcare costs and morbidly obese adults overall have 81% higher healthcare costs than non-obese adults. Obesity is currently treated with dietary, pharmacological, and/or surgical approaches that are often unsuccessful or are associated with additional risks. As the incidence and prevalence of obesity and obesity-related diseases are steadily increasing, there is a growing need to detect the key risk factors involved in disease development and modify standard treatment procedures and protocols. The most successful long-term strategy continues to be bariatric and metabolic surgeries, such as sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP). The NIH recommends bariatric surgery for participants with a BMI of 40 kg/m2 or greater or a BMI of 35 kg/m2 or greater and obesity related comorbidities. These surgeries enable participants to lose between 50% and 75% of excess body weight. Despite this success, participants are apprehensive and do not undergo bariatric surgery with the biggest fear being the many complications that come with the procedure. Studies have shown that 57-77% of participants are not interested in bariatric surgery although the participants qualify.(16) With the concern of complications from bariatric surgery, interest in endoscopic bariatric techniques has increased over the years. The techniques have been shown to be efficacious, reversible, relatively safe, and cost effective. Further, these techniques offer a therapeutic window for some participants who may otherwise be unable to undergo bariatric surgery. The American Society for Gastrointestinal Endoscopy have approved endoscopic procedures, such as balloon therapy, for participants with BMI in the 30-40 kg/m2 range.(17,18) However, the products used in these therapies also have several limitations primarily the inability to provide long term weight loss given the temporary nature of these balloons.(19) Common adverse events following intragastric balloon insertion include abdominal pain (33.7%), gastroesophageal reflux disease (18.3%), anorexia, and nausea (29%). Severe complications such as gastric ulcers (2%), small bowel obstruction (0.3%), perforation (0.1%), balloon migration (1.4%), and death (0.08%) are less common. Early balloon removal occurred in 9.1% of the study participants due to participant intolerance.(20) In a pilot study to assess safety and efficacy (BEAT Obesity), 20 morbidly obese participants with a BMI of ≥40 kg/m2 with no other comorbid conditions underwent bariatric embolization and were followed for 12 months. Participants were embolized with 300-500 µm Embospheres. None of the 20 participants in the BEAT Obesity trial (the largest prospective trial to date) had any major adverse events. Any gastric ulcers that occurred (40%) were asymptomatic and were completely healed by three months after the procedure.(21) There were many limitations of this study including the absence of a control cohort and non-compliance amongst study participants. A target population of participants with a BMI of 40 kg/m2 and above was too high considering the bariatric embolization procedure is comparable to endoscopic bariatric therapies rather than bariatric surgery. BEAT Obesity excluded participants with comorbidities, such as those who suffer from diabetes, who may greatly benefit from this procedure and are often the target population for endoscopic/surgical bariatric therapies. A larger bead size of 300-500 µm was specifically chosen compared to preclinical data and prior clinical reports due to concerns of gastric ischemia and ulceration. However, smaller bead size produces greater weight loss and hormonal shifts.(22) Investigators hypothesize that transvascular bariatric embolization results in safe and effective weight loss in obese participants compared to control subjects.

NCT ID: NCT04180436 Completed - Morbid Obesity Clinical Trials

Pharmacokinetics of Rivaroxaban After Bariatric Surgery

ABSORB
Start date: January 15, 2020
Phase: Phase 1
Study type: Interventional

Data on pharmacokinetics of rivaroxaban after bariatric surgery and in morbid obesity are sparse. The aim of this study is to assess the pharmacokinetic and pharmacodynamic parameters of rivaroxaban, used at a therapeutic anticoagulant dose, in patients with previous bariatric surgery, with sleeve gastrectomy or gastric bypass, and in morbid obese subjects. Four groups of 16 subjects per group are studied: Morbid obese subjects / Subjects who have undergone gastric bypass surgery / Subjects who have undergone sleeve gastrectomy surgery / Non-operated control subjects matched for age and BMI with operated subjects. All patients (obese, surgical patients, and controls) will receive rivaroxaban 20mg once daily during 8 days. Blood samples will be taken predose (Baseline) and 0.5, 1, 2, 3, 6, 9, 12 and 24h post rivaroxaban administration at day1 and day8. PK and PD parameters will be compared between groups in order to explore the impact of bariatric surgery, type of surgery and body mass index on the pharmacological profile of rivaroxaban.

NCT ID: NCT04165811 Completed - Obesity Clinical Trials

Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery

Start date: November 30, 2019
Phase: N/A
Study type: Interventional

In this study, our primary aim is; investigate the effect of aerobic dance based exercise program on lower extremity functions (walking, stair stroke climbing, etc.) in obese individuals awaiting bariatric surgery.

NCT ID: NCT04161924 Completed - Obesity, Morbid Clinical Trials

Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients

Start date: December 6, 2018
Phase:
Study type: Observational

The purpose of this research study is to learn if a new imaging processing technique called Simulated grid (SimGrid™) will help in getting better quality X-ray images in obese subjects. The GM85 digital radiography machine will be used to obtain X-ray images.

NCT ID: NCT04144361 Completed - Obesity, Morbid Clinical Trials

Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Start date: December 27, 2019
Phase: N/A
Study type: Interventional

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding