Clinical Research Directory

Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization

The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.

Improvement in Glycemic Response After Bariatric Surgery

decipher the role of microbiota in glycemic response change after bariatric surgery

Low-Flow Anesthesia and Perioperative Atelectasis in Laparoscopic Bariatric Surgery

The goal of this clinical trial is to learn whether low-flow anesthesia reduces perioperative atelectasis compared to normal-flow anesthesia in adults undergoing laparoscopic bariatric surgery. The main questions it aims to answer are: Does low-flow anesthesia result in a smaller increase in lung ultrasound score from baseline to postoperative hour 1? Does low-flow anesthesia result in better preservation of pulmonary function at postoperative hour 48? Researchers will compare low-flow anesthesia (fresh gas flow 0.5 L/min) to normal-flow anesthesia (fresh gas flow 2 L/min) to see if low-flow anesthesia reduces the extent of perioperative atelectasis as measured by lung ultrasound. Participants will: Be randomly assigned to receive either low-flow or normal-flow inhalational anesthesia with sevoflurane during surgery Undergo lung ultrasound assessments before surgery and at postoperative hours 1 and 24 Undergo spirometric testing one day before surgery and at postoperative hour 48

Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients

Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery

Transition to Ambulatory Bariatric Surgery (TABS) Trial

This study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. Patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. The study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.

The OAT Trail: The Obesity Anti-Coagulation Thromboprophylaxis Trial.

Blood clots in the legs or lungs (called venous thromboembolism or VTE) are one of the most serious complications after weight loss surgery. Most blood clots occur after patients go home from hospital, within the first 30 days after surgery. To prevent blood clots, all patients having weight loss surgery receive a daily blood-thinning injection for 21 days after their operation. Two blood-thinning injections are currently used at St Vincent's University Hospital for this purpose: enoxaparin (Clexane®) and tinzaparin (Innohep®). Both belong to a group of medicines called low molecular weight heparins (LMWHs). Patients with obesity process these medicines differently to the general population, and previous studies from our hospital have shown that fewer than 53% of patients achieve adequate blood-thinning levels with either injection when measured by a blood test called an anti-Xa level. Patients will be randomly assigned (like a coin toss) to receive either tinzaparin or enoxaparin for 21 days after their surgery. Both injections are already in routine use at this hospital. A single extra blood sample will be taken on the second day after surgery to measure the anti-Xa level, which tells us whether the injection is providing adequate protection against blood clots. This blood sample will be taken at the same time as routine post-operative blood tests so that no additional blood draws are required. The study will also look at rates of blood clots and bleeding events within 30 days of surgery, and will ask patients to complete a short questionnaire at their six-week follow-up appointment about their experience with the injection.

2024 Tirzepatide-Bariatric Surgery

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.

Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery

This is prospective, randomized study. The purpose of this study is to evaluate whether the addition of Suzetrigine to well established multimodal pain regimen for participants undergoing bariatric patients undergoing weight-loss surgery and cardiac patients undergoing sternotomy will reduce post-operative opioid consumption and pain scores.

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression

The aim of this study is to observe the antidepressant effect of low-dose esketamine in obese patients with preoperative depression and seeking bariatric surgery. We speculate that intraoperative infusion and the addition of a small dose of esketamine to the postoperative analgesic pump can help reduce the proportion of patients with depression after surgery, and may further improve postoperative recovery, reduce the use of postoperative opioids, shorten postoperative hospital stay, and improve postoperative quality of life of patients.

Periodontal Microbiota of Patients Candidates for Bariatric Surgery With Body Mass Index Greater Than 30

The goal of this observational study is to compare the microbiological composition of the periodontal plaque of obese people undergoing bariatric surgery according to their Body Mass Index. The main question it aims to answer is: Does obese patients have different microbiote according to their obesity? Obesity being classified in two groups : * group "obesity" for a BMI between 30 and 35 * versus "morbid obesity" group with a BMIabove 35. Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will answer questions about their quality of life, hygiene habits, and saliva and periodontal samples will be taken.

Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.

Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery

This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine, and control (placebo). Primary outcomes include total morphine consumption intra- and post-operatively. Secondary outcomes include postoperative pain scores, total analgesic consumption, time to first analgesic request, hemodynamic parameters, and patient satisfaction. This study seeks to explore safer, more effective pain management strategies to minimize opioid use in bariatric surgery patients.

Impact of a Pro-diversity Gut Microbiota Diet After a Bariatric Surgery on Gut Microbiota, Eating Behaviour and Sensory Function

Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery. The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery. The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand the mechanisms that may explain variations in response to bariatric surgery. The BariaGut Taste study is a prospective, randomized, controlled trial with two parallel groups, involving non-diabetic patients aged 25 to 65 y undergoing either sleeve gastrectomy or Roux-en-Y gastric bypass. The trial will be conducted at the digestive surgery department of Edouard Herriot Hospital, the endocrinology-diabetes-nutrition department of Lyon Sud Hospital Center, and the Human Nutrition Research Center Rhône-Alpes. 60 participants are expected to be recruited, with 30 in each arm. Participants will be enrolled before surgery during a routine care visit with the surgeon. They will then undergo a metabolic assessment visit conducted exclusively for research purposes. This visit will allow to collect baseline data on primary outcomes via blood, expired air, and stool samples, anthropometric measurements, indirect calorimetry, a battery of questionnaires (TFEQ-21, DEBQ, PHQ-9, SF36, GSES, PANAS, ESUL, BES, DERS, GAD-7, IPAQ, BAQ, GSRS, sensory alterations, Bristol and Likert scales, and FNS), computerized food preference tests (LFPQ), and a standardized, video-recorded ad libitum buffet. Participants will be followed up at 3, 6, and 12 months after surgery through visits combining clinical care and research assessments. The dietary interventions specific to each group will be provided since the 3-month visit. The assessments conducted before surgery will be repeated at 6 and 12 months, also integrating clinical care objectives. Additional blood, stool, and adipose tissue samples collected during surgery will be stored to create a biobank.

Indocyanine Green Fluorescence Angiography (ICG-FA) in Revisional Bariatric Surgery

This study will compare different doses of a green fluorescent product that is administered during weight loss surgery in order to observe where blood vessels are located. There is uncertainty around the optimal dose of this product for patients with obesity, so this study will aim to study if the dose in the minimal range recommended by international guidelines is sufficient for most patients or if higher doses are needed with increasing body mass index.

Digital Follow-Up and Nursing Education in Bariatric Surgery Patients

This randomized controlled experimental study aims to evaluate the effect of a PHP-MySQL database-based digital follow-up system combined with structured nursing education on quality of life, body mass index (BMI), and exercise habits in patients undergoing bariatric surgery. Although bariatric surgery is an effective treatment for morbid obesity, long-term success depends largely on adherence to lifestyle modifications, including regular physical activity and sustained behavioral change. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive structured nursing education along with an 8-week digitally monitored exercise program starting at postoperative month four. The control group will receive standard postoperative care. Outcomes will be assessed using the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II), BMI measurements, and the International Physical Activity Questionnaire (IPAQ). The study aims to provide evidence for integrating digital health technologies and structured nursing interventions into postoperative bariatric care.

Flow-Controlled Versus Volume-Controlled Ventilation in Bariatric Surgery

This prospective trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on intraoperative airway pressures and oxygenation in bariatric surgery under general anesthesia. Obesity is associated with altered respiratory mechanics, reduced functional residual capacity, and increased airway pressures, making the selection of an optimal ventilation strategy particularly important in this patient population. Adult patients aged 18-65 years with a body mass index ≥30 kg/m² and American Society of Anesthesiologists (ASA) physical status II-III will be allocated to receive either FCV or VCV as part of routine intraoperative mechanical ventilation. Ventilatory parameters, including peak and plateau airway pressures, pulmonary compliance, will be recorded at predefined intraoperative time points. The primary endpoint of the study is the PaO₂ value measured at the 20th minute under an FiO₂ of 0.8-1.0. By providing comparative data on respiratory mechanics and oxygenation, this study aims to contribute to the identification of lung-protective ventilation strategies and to optimize intraoperative ventilatory management in bariatric surgery.

Disordered Eating and Recurrent Weight Gain After MBS

Obesity represents an increasingly serious public health problem worldwide. According to the World Health Organization, one in eight individuals globally is affected by obesity. Bariatric surgery (BS) is recognized as the most effective treatment for severe obesity and has been shown to significantly improve obesity-related comorbidities. However, despite initially successful surgical outcomes, a substantial proportion of patients experience insufficient weight loss (IWL) or weight regain (WR) after surgery. Previous studies have identified multiple factors associated with post-bariatric IWL and WR, including older age, low socioeconomic status, higher baseline body mass index (particularly preoperative BMI \>50 kg/m²), type of surgical procedure, hormonal mechanisms, poor adherence to postoperative dietary recommendations, maladaptive eating behaviors, insufficient physical activity, and the presence of psychiatric comorbidities. Among these, behavioral factors appear to play a particularly critical role. Irregular eating patterns such as loss of control eating, maladaptive behaviors such as grazing, non-adherence to dietary guidelines, and a return to preoperative eating habits are frequently associated with weight regain. Additionally, physiological mechanisms, including increased appetite, food cravings, and altered hormonal regulation of energy intake, may further contribute to this process. Grazing behavior-defined as repetitive consumption of small amounts of food accompanied by a sense of loss of control-has been consistently associated with poorer weight outcomes after bariatric surgery. A large meta-analysis reported grazing prevalence rates between 16.6% and 46.6%, with weight regain observed in nearly half of post-bariatric patients. Moreover, lack of structured nutritional follow-up has been shown to significantly increase the risk of weight regain. Neurobehavioral changes also occur after surgery: while appetite and responsiveness to palatable foods typically decrease during the first postoperative year, these effects often diminish over time, with hunger, cravings, and portion sizes gradually increasing in some individuals. Long-term weight regain has been closely linked to disordered eating behaviors, including emotional eating, binge eating, compulsive eating, food addiction, and loss of control eating. Recent studies have demonstrated significant associations between weight regain and binge eating disorder, eating disinhibition, and impulsivity. Qualitative research further highlights that many patients struggle to manage emotional eating and require ongoing psychological and dietary support following surgery. Despite growing evidence emphasizing the behavioral and psychological components of post-bariatric outcomes, comprehensive studies that simultaneously evaluate nutritional status, eating disorders, and emotional factors in individuals experiencing IWL or WR remain limited. Therefore, the present study aims to assess nutritional status, eating disorder symptoms, and emotional factors in individuals who experience insufficient weight loss or weight regain after bariatric surgery. By integrating anthropometric, nutritional, behavioral, and emotional assessments within the same sample, this study seeks to provide a multidimensional perspective and contribute to the development of more effective multidisciplinary follow-up and psychodietetic interventions.

Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

Obesity is a health condition caused by excessive accumulation of body fat. This condition is linked to the development of chronic diseases and also places increased stress on the respiratory system, leading to respiratory disorders, exacerbation of preexisting respiratory conditions, and a decline in physical capacity and exercise tolerance. Respiratory muscle training has been shown to have beneficial effects on respiratory function in these patients, although the effects this strategy has on other metabolic and physiological aspects related to exercise and obesity that are affected remain unclear.

Scalp Hair Metabolomics in Severe Obesity

The purpose of this research study is to investigate how body weight and weight-loss surgery affect the natural chemicals found in scalp hair over time. We will also find out how common and severe hair thinning/hair loss and muscle loss are in the first 6 months after bariatric surgery.

BAR-TAX - Tranexamic Acid in Bariatric Surgery.

Perioperative bleeding is a relevant complication in bariatric surgery and may lead to hemoglobin decrease, blood transfusions, reinterventions, prolonged hospital stay, and increased healthcare costs. Tranexamic acid (TXA), an antifibrinolytic agent, has demonstrated efficacy in reducing surgical bleeding in several surgical specialties, with a favorable safety profile when appropriately used. However, evidence in bariatric surgery remains limited, particularly considering the intrinsically increased thromboembolic risk of obese patients. The BAR-TAX study is a prospective, single-center study conducted in a high-volume bariatric surgery center, aiming to evaluate the efficacy and safety of perioperative TXA administration compared with standard care without TXA. The primary objective is to assess whether TXA reduces the incidence of clinically significant bleeding within 48-72 hours after bariatric surgery. Secondary objectives include evaluation of hemoglobin drop, transfusion rates, need for hemostatic procedures or reoperation, thromboembolic events, postoperative complications, length of hospital stay, readmissions, and TXA-related adverse events.

Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

The purpose of the study is to determine how blood sugar levels in individuals with and without hypoglycemia after bariatric surgery respond to different doses of glucagon, a hormone that is usually present in your body that regulates blood sugar levels. In this study, there will be 4 visits to the clinical research center. In the first visit, medical history and physical exam will be performed, and blood samples will be taken to assess overall health. During visit 2, a continuous glucose monitor will be placed under the skin. (This may be combined with visit 1, depending on the schedule of visits.) In visit 3, we will test the effect of a total of 4 different doses of glucagon, in increasing doses. In visit 4, we will test the effect of a total of 3 doses of glucagon, in decreasing doses. For both visit 3 and 4, we will infuse labeled stable glucose to allow us to measure how much glucose the body is making, and will measure levels of hormones which regulate glucose, such as insulin and glucagon.

One-Year Outcomes After Conversion Bariatric Surgery

Obesity is a growing global public health problem, and bariatric surgery is currently the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. However, a subset of patients experience inadequate weight loss or weight regain following primary bariatric surgery, which may lead to the recurrence of metabolic complications and reduced quality of life. In such cases, conversion bariatric surgery, defined as the surgical conversion from one bariatric procedure to another, is considered an important therapeutic option. Despite the increasing number of conversion procedures, comprehensive longitudinal data evaluating anthropometric, biochemical, and nutritional outcomes after conversion bariatric surgery remain limited. This study aims to prospectively evaluate individuals undergoing conversion bariatric surgery due to weight regain following primary bariatric surgery. Anthropometric measurements, biochemical parameters, and nutritional status will be assessed preoperatively and at 1 year after surgery. By evaluating weight loss outcomes together with metabolic and nutritional changes, this study seeks to provide clinically relevant evidence to guide postoperative follow-up strategies, optimize nutritional management, and support multidisciplinary care in patients undergoing conversion bariatric surgery.

Effect of Intraoperative Salbutamol Administration on Mechanical Power and Respiratory Mechanics in Obese Patients Undergoing Laparoscopic Bariatric Surgery

The primary objective of this study is to evaluate the effect of intraoperative salbutamol administration on mechanical power in obese patients undergoing laparoscopic bariatric surgery under general anesthesia. Mechanical power will be measured at predefined intraoperative time points (T0, T1, and T2), and changes over time will be compared to determine the impact of salbutamol on the overall energy delivered to the respiratory system during mechanical ventilation. Secondary objectives include the assessment of intraoperative respiratory mechanics, including peak airway pressure (Ppeak), plateau pressure (Pplat), driving pressure (Pdrive), airway resistance (Raw), and lung compliance, as well as gas exchange parameters (SpO₂, EtCO₂) and hemodynamic variables (mean arterial pressure). Postoperative pulmonary outcomes will be evaluated using the Melbourne Group Scale (MGS), with a score greater than 4 indicating the presence of postoperative pulmonary complications. The study aims to investigate whether improvement in intraoperative mechanical power and respiratory mechanics is associated with a reduction in postoperative pulmonary complications in this high-risk population.

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy

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