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Obesity, Morbid clinical trials

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NCT ID: NCT04643262 Enrolling by invitation - Morbid Obesity Clinical Trials

Sleeve Gastrectomy: Outcome, Morbidity and Mortality. A Multicentric Retrospective Trial

PSICHE
Start date: January 1, 2015
Phase:
Study type: Observational

Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is a safe and effective technique in terms of excess weight loss and it is, moreover, a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behavior, glycemic control and intestinal functions.Regarding a technical point of view, LSG might be considered a time saving procedure for the absence of intestinal anastomosis. The most frequent and sometimes dangerous complications are leaking, hemorrhage, splenic injury, stenosis and Gastro-Esophageal Reflux Disease (GERD). Despite its established efficacy and safety, dispute still exists on the optimal conduction of LSG operative technique: bougie size, distance of resection margin from the pylorus, the shape of section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing are among the most controversial issues . Thus, the primary aim of the present retrospective multicentric study is to evaluate intra and peri-operatory (< 30 days) and post-operative (> 30 days) morbidity and mortality rates of patients undergone LSG, and the correlation of the latter rates with different surgical measures. Secondary aim is to evaluate the strategy for the treatment of the complication, and if there is a correlation between morbidity/mortality and volume of the Bariatric Center

NCT ID: NCT04633941 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of Social Distancing on Bariatric Versus Non-Surgical Obese Patients During COVID-19 Pandemic

Start date: June 1, 2020
Phase:
Study type: Observational

In response to the COVID-19 pandemic, weight management programs and metabolic surgery have been deferred to contain the virus. Quarantine and social distancing negatively impact dietary, exercise and psychological health of obese individuals. The study aims to evaluate the impact of social distancing measures on post-metabolic surgery patients compare to non-surgical obese patients and discuss potential strategies for management post COVID-19.

NCT ID: NCT04633512 Enrolling by invitation - Colorectal Cancer Clinical Trials

Safety and Feasibility of ActivSightTM in Human

Start date: November 17, 2020
Phase: N/A
Study type: Interventional

ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

NCT ID: NCT04626570 Recruiting - Obesity Clinical Trials

Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity

ADALOB
Start date: January 20, 2021
Phase: N/A
Study type: Interventional

Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life. Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis. Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France. The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).

NCT ID: NCT04626232 Terminated - Morbid Obesity Clinical Trials

Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients

NSLEEVE
Start date: September 12, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique

NCT ID: NCT04619771 Recruiting - Insomnia Clinical Trials

M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

MASTER
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This study is a longitudinal clinical trial designed to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with insomnia following bariatric surgery.

NCT ID: NCT04613635 Recruiting - Morbid Obesity Clinical Trials

Stratafix vs. Vicryl OAGB / MGB Suture Study

Start date: November 6, 2020
Phase: N/A
Study type: Interventional

To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.

NCT ID: NCT04610099 Recruiting - Morbid Obesity Clinical Trials

Creating a Laparoscopic Banded Sleeve Gastrectomy

RING
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.

NCT ID: NCT04600596 Completed - Obesity, Morbid Clinical Trials

Photographic Food Recognition and Meal Size Estimation Before and After Roux-en-Y Gastric Bypass

Start date: June 1, 2019
Phase:
Study type: Observational

Direct measurements of changes in food selection in humans after RYGB have been limited by the unreliability of patients, which poses significant methodological and conceptual challenges to researchers and study design. Self-monitoring requires time and effort, and many find tracking of dietary intake tedious, which contributes to attrition. Direct measurements, however, represent an essential component in the attempt to understand how RYGB alters eating and food preferences, but laboratory settings preclude a real-life environment. The aim of this study is to investigate changes in food preferences, total energy intake of the three primary macronutrients and meal patterns between obese women (BMI ≥ 35) before and after Roux-en-Y gastric bypass and lean (BMI ≤ 25) and obese (BMI ≥ 35) controls by means of photographic food recognition with a mobile application.

NCT ID: NCT04592601 Not yet recruiting - Metabolic Syndrome Clinical Trials

The S.L.I.M.M.S. Procedure for Severe Clinical Obesity

SLIMMS
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Assessment of Gastric Bypass combined with Vertical Sleeve Gastrectomy as primary treatment for patients with severe clinical obesity. Average percentage of total weight loss and percentage excess weight loss will be computed at 6 months, one year and then annually. Comorbid conditions, quality of life measures, appetite and satiety measures and adverse events will be tracked.