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 and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

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 evaluating the safety, tolerability, and effectiveness of apraglutide compared with a placebo in adults with short bowel syndrome associated with intestinal failure SBS-IF. This Phase 3, double-blind, randomized, placebo-controlled study aims to include about 124 adult participants who rely on parenteral support PS at least three days per week. Participants are stratified by anatomy and baseline PS volume to ensure balanced study groups. Participants will be randomly assigned to receive either weekly subcutaneous injections of apraglutide or placebo for 24 weeks. The study consists of four periods Screening including optimization and stabilization, Treatment, Safety Follow-up after the last dose, and an Anti-Drug Antibody Follow-up period. Those completing treatment may join a long-term extension study with apraglutide or complete a safety follow-up visit before entering the antibody monitoring phase. During the study, participants will have their weekly parenteral support volume measured to assess changes. Additional assessments include reductions in PS days per week, achievement of enteral autonomy, and patient-reported global impression of change. Safety will be monitored through adverse event tracking and laboratory tests. Participants are expected to adhere to fluid intake monitoring and may undergo colonoscopy or imaging to remove any polyps. The entire participation timeline extends beyond treatment to ensure thorough safety and immune response evaluation.

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 participants 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.