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Obesity, Morbid clinical trials

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NCT ID: NCT05064722 Active, not recruiting - Obesity, Morbid Clinical Trials

Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve

Start date: November 8, 2021
Phase: N/A
Study type: Interventional

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a dual-path duodenal-ileal (D-I) diversion either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SNAP-S/SNAP-PS procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

NCT ID: NCT05049824 Active, not recruiting - Obesity, Morbid Clinical Trials

Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy

SNAP-PS
Start date: October 26, 2021
Phase: N/A
Study type: Interventional

Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.

NCT ID: NCT04844320 Active, not recruiting - Back Pain Clinical Trials

THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS

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

Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress. The aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.

NCT ID: NCT04834635 Active, not recruiting - Obesity, Morbid Clinical Trials

The FundoRingOAGB Versus Non-wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass

FundoRingMGB
Start date: March 29, 2021
Phase: N/A
Study type: Interventional

Currently, one anastomosis gastric bypass (OAGB) or mini-gastric bypass (MGB) is a common bariatric procedure for treating obesity. Weight gain after surgery is a big problem in bariatric practice. Therefore, adjustable bands and rings are used, for example, "FobiRing". But foreign material can cause complications - the erosion of the stomach wall. For this reason, surgeons avoid the use of various mechanical devices on living tissues. The greatest criticism is of the OAGB for the likelihood of biliary reflux. In case of reflux of bile into the esophagus after surgery, as a rule, a second operation is required with conversion OAGB to the Roux-en-Y method. In addition, along with obesity, gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often in bariatric practice, hiatus cruroraphy is performed, and less often fundoplication using the fundus of the excluded part of the stomach. We hypothesize that total fundoplication can not only treat GERD but also significant prevent the return of weight like after a banded gastric bypass and prevent postoperative bile reflux in the esophagus. The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms. Methods: Adult participants (n=1000) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group).

NCT ID: NCT04768127 Active, not recruiting - Obesity, Morbid Clinical Trials

Adipositas Care & Health Therapy

ACHT
Start date: May 15, 2020
Phase: N/A
Study type: Interventional

ACHT - Adipositas Care and Health Therapy - is a structured, digitally-supported, cross-sectoral and close to home program developed for the postoperative care of patients following obesity surgery. The aim is to ensure the long-term success of therapy following bariatric surgery. ACHT was selected by the Federal Joint Commission for support under the Innovation Fund. The project started in July 2019 and will end in December 2022.

NCT ID: NCT04653103 Active, not recruiting - Obesity Clinical Trials

NASH in Subjects With Different Classes of Obesity

CONNECT
Start date: November 20, 2020
Phase:
Study type: Observational

It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.

NCT ID: NCT04583683 Active, not recruiting - Obesity Clinical Trials

Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities

ARGOS
Start date: September 30, 2020
Phase: N/A
Study type: Interventional

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

NCT ID: NCT04576975 Active, not recruiting - Surgery Clinical Trials

Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

Start date: April 20, 2021
Phase: Phase 3
Study type: Interventional

The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. Dexmedetomidine is selective α2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .

NCT ID: NCT04471077 Active, not recruiting - Obesity, Morbid Clinical Trials

Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Start date: December 1, 2018
Phase:
Study type: Observational

Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We compared samples from patients achieving favorable outcomes in terms of weight-loss with patients, who did not respond optimally to the bariatric operation. Materials and methods Design This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2⁠. Analysis and endpoints Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients ing Group 1 and Group 2. Secondary endpoint was to compare the results of microbiota analysis between LSG and LRYGB.

NCT ID: NCT04469712 Active, not recruiting - Metabolic Syndrome Clinical Trials

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.