Bariatric Surgery

Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve health outcomes for people with obesity and related medical conditions. This study aims to see if tirzepatide reduces inflammation in tissues and blood before surgery and how these changes relate to weight loss, metabolic improvements, and fewer complications after surgery. The trial is a Phase 4 interventional study comparing patients who take tirzepatide with those who do not before their planned surgery. Participants who are assigned to the tirzepatide group will self-inject 2.5 mg of tirzepatide once weekly for three months before surgery, following dose escalation instructions if needed. Both groups will receive education on dietary and lifestyle changes. During the three months before surgery, participants will visit the endocrine clinic monthly for drug prescription and side effect monitoring. The study continues through the surgery and post-surgery follow-up periods. Throughout the study, participants will keep a diary of drug use and side effects, and researchers will measure inflammatory markers such as C-reactive protein, interleukin 6, tumor necrosis factor, leptin, adiponectin, and RAAS at baseline, three months after drug use, and several times after surgery. Weight, blood pressure, blood sugar, cholesterol, and surgical complications will also be tracked up to one year after surgery. Participant involvement includes regular clinic visits, lab tests, and monitoring to assess the impact of tirzepatide on surgical outcomes and inflammation.

Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease (GERD) in patients who have undergone laparoscopic gastric sleeve (LGS) surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Researchers are evaluating the effects of intensive weight loss treatment on renal outcomes in patients with diabetic kidney disease (DKD), particularly focusing on those with rapidly progressing diabetic nephropathy. The study aims to establish a patient group receiving such treatments and to develop a prediction model for kidney health improvements following weight loss. Participants are divided into two groups: one receiving bariatric surgery, which includes laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on beta-cell function, and another group receiving non-surgical therapy comprising diet management, exercise, metformin, GLP-1 receptor agonists, and other weight loss medications. The study monitors outcomes at 1, 3, 6, and 12 months after intervention. During the study, participants will have regular assessments measuring total weight loss, kidney function markers such as serum creatinine and glomerular filtration rate, various blood glucose parameters, waist and hip circumference, urinary microalbumin, other urine tests, and medication status. These evaluations help track the impact of the treatments on kidney health and metabolic control over the course of one year.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Short Bowel Syndrome (SBS) is a rare condition where a large part of the intestine is missing or has been removed, causing difficulty in absorbing enough food, water, and nutrients. This study focuses on children and teenagers with SBS who depend on parenteral support (PS) for more than 42 days to stay healthy. Researchers aim to learn how well teduglutide works to reduce the need for PS and to assess its safety in this group. The study includes three groups of participants: those who completed a 24-week teduglutide treatment before joining the study, those who started treatment before the study but have not finished 24 weeks, and those who will begin treatment after enrolling. Data will be collected retrospectively for earlier treatments and prospectively for ongoing or future treatments, covering up to 48 weeks for new starters. No intervention is administered by the study itself as it is observational. Participants will have their medical records reviewed, and new data collected during the study period. Researchers will measure changes in weekly PS volume, growth parameters, nutrition support, and safety through lab tests, vital signs, and adverse events. The main outcome is the percentage of participants achieving at least a 20% reduction in weekly PS volume at 24 weeks. The study will continue until September 2027, with ongoing monitoring of health and treatment responses.

Researchers are conducting a survey to understand how well participants and physicians know how to use GATTEX, a treatment for Short Bowel Syndrome (SBS), and to identify potential risks. This survey is part of a safety program called the Risk Evaluation and Mitigation Strategy (REMS), required by the US FDA to ensure certain medicines with serious risks are used safely. The main goal is to assess knowledge about the necessary checkups and tests while using GATTEX and the possible risks involved. The survey is non-interventional and participants include those who have taken GATTEX within 60 days before the survey and healthcare providers in the US who have prescribed GATTEX at least once. The survey can be completed online, by telephone, or on paper, based on the participant's preference. No study medicines are provided during this research. Participants will answer questions to measure their understanding of GATTEX safety and use. Researchers will count how many provide correct answers and how well they understand the knowledge areas of the survey. This assessment occurs every two years as part of ongoing safety monitoring. The survey aims to help improve safe use of GATTEX over time.

Obesity affects 3% to 4% of adolescents and can lead to heart-related deaths in adulthood. Bariatric surgery is known as a leading treatment for weight loss and preventing obesity-related health problems in adults, but its use and safety in teenagers are still being defined. Since 2008, some university hospitals in France have been performing bariatric surgery on adolescents, leading to health authority recommendations in 2016. Continued monitoring is important as these surgical techniques become more common among young patients. This observational study focuses on laparoscopic adjustable gastric banding as a weight-loss surgery option for adolescents aged 14 to 20. The Angers University Hospital, a leader in adolescent bariatric surgery, is updating data on how well this surgery works for weight loss and related health conditions. The study also tracks medical, psychological, and surgical complications over time. Participants will be followed for at least two years after surgery with assessments of weight changes, insulin resistance, blood fat levels, liver health, and obesity-related conditions. The study also evaluates mental health, quality of life, cosmetic satisfaction one year after surgery, and surgical complications. These comprehensive evaluations aim to improve the management of adolescent obesity through surgery and monitor long-term outcomes.

Researchers are studying how the body processes alcohol and how alcohol affects mood and blood sugar in men and women who have undergone sleeve gastrectomy, a type of weight-loss surgery. The study aims to find out if there are differences between men and women in how alcohol is handled after this surgery, and how drinking alcohol on an empty stomach versus after a meal affects blood sugar control. The study compares participants who had sleeve gastrectomy 1 to 5 years ago with people of similar age, body composition, and drinking habits who did not have surgery. Participants will undergo two types of alcohol tests: one where alcohol is given orally at a dose based on fat-free mass, either after fasting overnight or after a standard meal, and another where alcohol is administered intravenously using a controlled infusion to maintain a set blood alcohol concentration. These tests allow researchers to measure alcohol absorption, subjective effects, and blood sugar responses in different conditions. During the study, participants will have blood alcohol levels, subjective alcohol effects, and blood glucose measured from before alcohol intake up to 180 minutes afterward. Gut hormones and other peptides will also be monitored. Researchers will compare responses between men and women and between those who had surgery and those who did not. The study will last until August 2028, and participation involves scheduled visits for testing under fasting and fed states.

Researchers are studying the outcomes of bariatric surgery, focusing on patients with morbid obesity who have undergone procedures like Roux en Y gastric bypass. This study compares the quality of life and postoperative course of patients treated for internal hernia with those who had an uncomplicated recovery after surgery. Data were collected prospectively starting in 1996 at the University Hospital of Strasbourg, France, with patient information anonymized for research purposes. The study includes various bariatric procedures such as laparoscopic Roux en Y gastric bypass, sleeve gastrectomy, gastric banding, and intragastric balloon placement. Each procedure is described in detail, including surgical techniques and device use. Patients were evaluated preoperatively by a multidisciplinary team, and follow-up data on weight loss, nutritional status, and complications were collected over many years. Participants undergo regular assessments including nutritional counseling, psychological evaluation, imaging, blood tests, and quality of life questionnaires. The study tracks outcomes like excess weight loss, body mass index, vitamin levels, glucose metabolism, lipid profile, and postoperative morbidity at intervals up to 30 years. Quality of life is measured using specific questionnaires, and data on abdominal pain and weight loss are collected by phone. This long-term monitoring helps understand the impact of internal hernia on patient recovery and well-being after bariatric surgery.

Researchers are exploring the connection between mental health disorders and obesity, focusing on adults with overweight or obesity who often have psychiatric conditions like mood disorders, anxiety, attention deficit disorder, and binge eating disorder. This observational study aims to develop better screening tools for these mental health issues and understand their impact on obesity treatment and management. The study also seeks to identify underlying biological and psychological factors linked to this combination of conditions. Participants in this study will undergo assessments using several questionnaires to evaluate symptoms related to binge eating, anxiety, depression, attention deficit, food addiction, and impulsive behavior. The study collects data from medical records including sociodemographic, anthropometric, and biological information to support research on the links between mental health and obesity. Authorization will be sought from participants to access their medical records for comprehensive data collection. During the study, participants will provide information through various mental health and sociodemographic questionnaires at baseline. Researchers will analyze the prevalence of psychiatric disorders in this population and assess how these conditions affect obesity management. The study is observational, with no investigational treatments administered. Participants' data will contribute to developing personalized resources to support mental health and obesity care. The study is expected to continue until November 2072, with ongoing data collection and analysis.