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Obesity, Morbid clinical trials

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NCT ID: NCT06133413 Not yet recruiting - Surgery Clinical Trials

Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations

COMPA
Start date: May 2024
Phase: N/A
Study type: Interventional

In this research, we hypothesize that post-operative monitoring implemented with a connected scale after the 1st year (weight nadir period) post obesity surgery (i.e. sleeve and RYGB) would reduce the percentage of patients with excessive weight regain (>10% regain of lost weight) by improving the quality of follow-up and long-term results. To do this, we are carrying out a comparative study on 182 patients, controlled, randomized per patient, ratio 1/1, open, in two parallel arms. Patients will be followed for 12 months and divided into one of the following two groups: - Control group: Standard follow-up - Interventional group: Standard follow-up + weekly weighing with the "Body Comp Pro" connected scale During their follow-up period, patients in the intervention group will have to weigh themselves at least once a week using the "Body Comp Pro" connected scale. The information will be transmitted to the investigation team via a secure platform available 24 hours a day. Alerts will be generated from a weight regain > 5% of the baseline weight, allowing early management of weight regain.

NCT ID: NCT06119516 Not yet recruiting - Obesity, Morbid Clinical Trials

Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.

TGV-MOA
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). The intervention consists of personalized measurements and calculations of the different pressures inside the thorax. The main question to answer is: • Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings than suggested by a strategy largely used in ARDS patients in France? A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired. Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefit of this personalized approach.

NCT ID: NCT06021873 Not yet recruiting - Obesity, Morbid Clinical Trials

Evaluation of the Non-inferiority of the Robotic Approach Over the Laparoscopic Approach in Patients Who Are Candidates for Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S)

LvRSADIS
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Treating patients with super-obesity has always been challenging for bariatric surgeons due to the higher risk of postoperative complications and the limited success of commonly used bariatric procedures (restrictive and hypo-absorptive). In this context, these patients are often considered for more complex procedures, such as hypo-absorptive interventions. Over the past 15 years, a new hypo-absorptive procedure called single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has been introduced and recognized as a bariatric procedure by leading national and international scientific societies. It has shown promising short- and medium-term results regarding weight loss and metabolic improvements. The SADI-S procedure is a technically complex multi-quadrant surgery. This study aims to evaluate the equivalence in terms of morbidity between laparoscopic and robotic approaches for patients undergoing this procedure.

NCT ID: NCT05974995 Not yet recruiting - Endometrial Cancer Clinical Trials

Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer

RObese
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI >= 30) patients with endometrial carcinoma.

NCT ID: NCT05958615 Not yet recruiting - Obesity, Morbid Clinical Trials

Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners

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

The goal of this waitlist-control design, pilot randomized controlled trial is to test feasibility, acceptability, and preliminary efficacy of a remotely-delivered dyadic positive psychology intervention for patients 2 years after bariatric surgery and their romantic partners (called ReConnect). The main question it aims to answer is whether the intervention results in improvements in depressive symptoms for patients and partners. The additional questions it aims to answer are whether the intervention results in improvements in resilience, relationship satisfaction, eating and physical activity behaviors, and weight maintenance for those in the intervention versus waitlist control condition. Participant couples randomly assigned to the intervention condition will engage in ReConnect for 8 weekly modules and associated positive psychology activities, some individually and some as a couple. Participant couples randomly assigned to the waitlist control condition will wait for 8 weeks to begin the 8 week intervention. All participants will fill out assessment measures at baseline, 8 weeks, and 16 weeks.

NCT ID: NCT05948852 Not yet recruiting - Obesity, Morbid Clinical Trials

Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)

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

This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.

NCT ID: NCT05938335 Not yet recruiting - Obesity, Child Clinical Trials

Sequencing of 14 Genes From Leptin Melanocortin Pathway in Severe Obesity in Childhood.

OBEGEN
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

About 380 million children and adolescents suffer from overweight and obesity at the global level. Obesity results from the interplay between biological (sex, age, fetal programming, gut microbiota, epigenetics, and genetics) and environmental factors (e.g., unhealthy diet, physical inactivity, stress). Mutations in genes from leptin melanocortin pathway are involved in "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. Exact frequencies of mutation in these genes are not precisely evaluated in french children with severe obesity. Moreover new treatment, such seltmelanotide are avalaible in case of certain mutation, leading to a significative weight loss in treated patients.

NCT ID: NCT05927519 Not yet recruiting - Obesity, Morbid Clinical Trials

Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study

Start date: December 5, 2023
Phase: N/A
Study type: Interventional

Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, perioperative hemodynamic variables, and postoperative complications will also be recorded.

NCT ID: NCT05713071 Not yet recruiting - Obesity Clinical Trials

Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity

BEAM
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin). This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.

NCT ID: NCT05697744 Not yet recruiting - Obesity, Morbid Clinical Trials

Evaluation of Vidiac Scores of Obese and Morbid Obese Patients Intubated by Videolaryngoscopy

Start date: February 2023
Phase:
Study type: Observational [Patient Registry]

The aim of the study was to observe the vidiac score values of only patients with obesity as a risk factor for difficult intubation. Secondly, it was aimed to evaluate the number of intubation attempts and intubation time, vidiac scores between obese and morbid obese patients and to reveal the differences, if any.