Bariatric Surgery

Explore bariatric surgery research studies. Discover clinical trials for weight management. All studies meet HIPAA and IRB compliance requirements.

Search Bar & Filters

Found 202 Actively Recruiting clinical trials

T

RECRUITING

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.

18+ yearsAll GendersPHASE4
1 location
S

RECRUITING

Healthy Volunteer

Roux-en-y gastric bypass is performed with the patient in the French position by a bariatric surgeon with 8 years of experience. A single port was placed in the umbilicus, an additional trocar (5mm) was placed in the right side of the abdomen. The surgery is started by performing the liver retraction with the grasper plus magnet attached to the border for the correct visualization of the surgical field. Later, the division of the major curvature of the omentum is started, and as it is performed in a superior direction, the magnet is positioned to retract the fundus and finishing exposing the esophageal hiatus where a hiatal hernia is visualized, which is decided to be repaired transoperatively. For the hiatoplasty, after placing a reference around the stomach, the magnet is positioned in that reference to retract the stomach and esophagus and to be able to suture the hernia defect. Then we proceed to perform the RYGB with the simplified technique, starting with the reference attached to the magnet but this time at the opposite end to start the resection of the lesser omentum, a minor step prior to the confection of the pouch. The pouch confection is done with 3 blue cartridges. Continuing with the procedure, the retraction of the transverse colon is performed with the use of the magnet to visualize the treitz angle and start the 60 cm measurement of the biliopancreatic limb. Later, gastrojejunal anastomosis is performed traditionally. Once this step is finished, the 100 cm alimentary limb is measured and then, the magnet-assisted jejunal anastomosis is performed. The Petersen defect and the intermesenteric defect is closed assisted by magnets. A methylene blue leak test is routinely performed, with negative results, this time testing both anastomoses. Finally, the magnet-assisted omega section is made with the retraction of the limb to finish the Roux-en-Y.

18-65 yearsAll Genders
1 location
A

RECRUITING

Establish a cohort of diabetic kidney disease(DKD) patients with intensive weight loss treatment to evaluate the impact of intensive weight loss treatment on the renal prognosis of DKD and construct a prediction model for the improvement of renal outcomes after weight loss.

18-65 yearsAll Genders
1 location
A

RECRUITING

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.

22+ yearsAll Genders
4 locations
A

RECRUITING

Healthy Volunteer

Procedure Description 1.2.1 Roux-en-Y Gastric Bypass The RYGB connects a limb of the intestine to a much smaller stomach pouch, which prevents the bile from entering the upper part of the stomach and esophagus, thereby effectively bypassing the remaining stomach and first segment of the small intestine. 21 The first step of RYGB involves the creation of the gastric pouch. The angle of His is identified with the fundus retracted laterally. The peritoneum, over the angle of His, is dissected with ultrasonic shears or scissors and carried posterior to identify the path for a linear stapler and the left crus of the diaphragm. Next, the mesentery to the lesser curve of the stomach is divided by a stapler. Once the retrogastric plane in the lesser curve is created, two serial applications of stapler will be used to create a 20 mL gastric pouch. 21 The second step is the creation of jejunojejunostomy. A stapler is utilized to create the anastomosis. The common enterotomy is closed with either a single running layer of 2-0 Vicryl or a second firing stapler. Finally, the gastrojejunal anastomosis is created and the Roux limb is pulled up to the level of the gastric pouch. 21 1.2.2 Sleeve Gastrectomy The SG is a restrictive procedure in which a partial left gastrectomy of the fundus and body of the stomach is performed in order to create a long tubular "sleeve" along the lesser curvature. The weight loss and resolution of comorbidities are attributed not only to the restrictive nature of the procedure but also to restriction by the pylorus, decreased ghrelin, increased satiety, increased gastric emptying, and faster small bowel transit times with a component of malabsorption.17-20 1.2 Aim(s)/Objective(s) The overall aim of this study is to evaluate and compare outcomes associated with robotic-assisted and laparoscopic bariatric surgery. 1.3 Rationale for the Study Studies to date have drawn partial contrasting conclusions when comparing robotic-assisted and laparoscopic bariatric surgery. There is a need to collect more scientific evidence data around the clinical outcomes of bariatric surgery performed with either robotic-assisted or laparoscopic surgery to describe the potential advantages of these techniques. 1.4 Hypothesis 1.4.1 Primary Hypothesis We hypothesize that the RYGB will indicate better outcomes compared to the SG. 2\. OBJECTIVES AND STUDY OUTCOME MEASURES 2.1. Study Objectives The primary objective of this study is to retrospectively compare perioperative outcomes through discharge and short-term outcomes through 30 days after robotic-assisted and laparoscopic bariatric surgery. 2.2. Study Outcome Measures Baseline patient characteristics, intraoperative, post-operative, and short-term clinical data will be obtained from hospital records for a total of up to approximately 400 robotic-assisted and laparoscopic cases among the four subgroups: robotic-assisted RYGB, robotic-assisted SG, laparoscopic RYGB, and laparoscopic SG. 3\. STUDY DESIGN This is a multi-center, retrospective chart review study of all consecutive cases of RYGB and SG, performed by participating surgeons at their respective institutions that meet the study inclusion and exclusion criteria. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until and going back to 2017 (i.e. most current cases in 2020 and chronologically going back through 2017). Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating institution/ investigator and after IRB approval has been obtained. It is anticipated that the retrospective chart review will span the period between January 1, 2017 through 30 days prior to IRB approval of the study at each institution. Perioperative and short-term clinical data will be obtained from institutional records. Each participating site and the participating surgeons at those institutions will contribute approximately a minimum of 10 to a maximum of 50 cases to a subgroup. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution to 2017. All the data variables will be documented in the case report forms. This section will provide an overview of the data collected which will include, but are not limited to, the following: * Pre-Operative Information: Demographics (e.g. age, gender), patient characteristics (e.g. BMI, ASA Class), and pre-operative medical history (e.g. tobacco use, previous abdominal surgery, comorbidities: hypertension, cardiopulmonary disease, diabetes) * Intra-Operative Data: Operative time, total OR time, bariatric procedure (robotic-assisted RYGB or SG and Laparoscopic RYGB or SG), concomitant procedures, transfusions, conversions, intraoperative adverse events * Post-Operative Data (up to discharge): Post-operative adverse events, discharge status, hospital length of stay, information on enhanced recovery program * Short-Term Follow-Up Data (up to 30 days post-discharge): Adverse events up to 30 days, re- admissions, re-operations related to the index procedure Please refer to the case report forms for complete details of data to be collected. Information regarding adverse events will be collected through this study; a list of applicable adverse events can be found below. Because the data will have been de-identified and is archival in nature, there will be no active subject recruitment and no patient consenting is required. A study specific Informed Consent Waiver for retrospective data collection will be obtained for this study, as required by the institution's IRB policy. The study duration is anticipated to be approximately 18 months. * The site activation consisting of IRB submission/approvals, contract execution, and training is anticipated to be completed in approximately 3 to 4 months * Chart review, data collection, and entry are anticipated to be completed in approximately 6 to 8 months * Data review is anticipated to be completed in approximately 2 months * Data analysis is anticipated to be completed in approximately 4 months Study Training All investigators/ site personnel will be trained on the study protocol at a Site initiation visit or at another appropriate training session. Site initiation visit will be scheduled only upon receiving a fully executed data collection agreement and IRB approval. Training of investigators and site study personnel will include, but are not limited to, the investigational plan, protocol requirements, CRF completion, EDC training, recording of adverse events, and study personnel responsibilities related to study compliance and conduct. Adverse Events Adverse event data will be collected only for those associated with the primary bariatric procedures (RYGB and SG procedures) requiring intervention. The investigator will be responsible for reviewing all the adverse event case report forms. A detailed list of adverse events is provided in the case report forms. Some examples of commonly anticipated intraoperative and post-operative adverse events are provided below but reported adverse events are not limited to the following. * Examples of intraoperative adverse events * Bleeding requiring an intervention * Visceral injury including but not limited to injury to liver, injury to diaphragm, injury to spleen * Vascular injury including major vascular injury requiring intervention * Adverse events related to anesthesia (prolonged intubation defined as continued intubation in the recovery room or ICU/step down unit after surgery,) * Nerve injuries due to patient positioning * Other intraoperative injuries * Examples of postoperative adverse events * Postoperative bleeding requiring transfusion or reoperation or another procedure * Bowel obstruction * Anastomotic leak * Anastomotic stricture/ stenosis * Clostridium difficile infection * Liver failure * Pancreatitis * Peritonitis * Acid reflux * Stomach or intestine ulceration * Wound adverse events: Surgical site Infection-superficial/deep (incisional dehiscence) * Deep Venous Thrombosis (DVT) * Genitourinary adverse events (Urinary Tract Infection (UTI) requiring antibiotics) * Cardiac Adverse events (Atrial arrhythmia requiring treatment, Ventricular arrhythmia requiring treatment, cardiac arrest with CPR, MI) * New onset renal failure (per the RIFLE criteria) * Sepsis requiring antibiotics * Other adverse events: includes any cardiac, pulmonary, gastrointestinal, genitourinary, and neurological adverse events outside of those already listed above Pre-existing conditions are not reportable as adverse events unless the condition worsens or continues after the procedure. Any events inherent to the procedure are not reportable as adverse events unless the condition worsens or continues after the procedure beyond the expected time frame. Some examples of non-reportable adverse events are listed below: * Anesthesia related nausea/vomiting occurring \<24hrs after surgery * Leukocytosis as a result of normal post-operative stress response occurring \<72hrs after surgery

18+ yearsAll Genders
1 location
A

RECRUITING

Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients) because a big part of it has been removed, bypassed or did not develop normally at birth and the children need support through a vein (parenteral support or PS) for more than 42 days to stay healthy and keep their energy. SBS in children is defined mainly by how well the intestine works and how long the children need this support, not just by how long the intestine is. The main aim of the study is to learn how well the teduglutide works in children and teenagers with SBS and who need PS. Another aim is to find out how well teduglutide works for participants to lower the amount of PS needed. Also, the study wants to learn more about how safe teduglutide is in children and teenagers with SBS who need PS. The study will review data already existing in the medical records of participants as well as collect new data during the study.

1-17 yearsAll Genders
4 locations
A

RECRUITING

The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey). This survey, which is conducted every two years, is part of the Gattex Risk Evaluation and Mitigation Strategy (REMS). REMS is a safety program required by the US health authority (FDA) for certain medicines that have serious risks. REMS intends to help reduce these risks while still allowing treatment. The goal is to make sure these medicines are used in the safest way possible. The main aim of this survey is to find out how well participants and physicians understand the checkups and tests (so called monitoring) participants should have while taking GATTEX, and the possible risks or of using GATTEX to treat Short Bowel Syndrome. The knowledge assessment survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred. No study medicines will be provided to participants in this study.

18+ yearsAll Genders
1 location
A

RECRUITING

Bariatric surgery is an effective treatment for severe obesity; however, the rapid postoperative weight loss period is frequently accompanied by unfavorable changes in body composition, including reductions in lean mass and muscle performance, which may compromise functional capacity during recovery. Therapeutic exercise is commonly recommended as part of metabolic rehabilitation; nevertheless, evidence regarding short, structured programs initiated early after surgery-and particularly regarding changes in muscle quality-remains limited. This study will evaluate within-subject changes in muscle quality, body composition, and functional response following a concurrent exercise program in adults after bariatric surgery. Additionally, the association between exercise adherence and the magnitude of change in primary outcomes will be explored using multivariable analytical models. This is a single-center, prospective, longitudinal, quasi-experimental study with a one-group pre-post design. Participants will be recruited from BUPA Clinic Santiago and will include men and women aged 18 to 60 years who underwent sleeve gastrectomy or Roux-en-Y gastric bypass, are PAD voucher beneficiaries, and have a medical indication for metabolic rehabilitation. After eligibility screening and informed consent, participants will enter the protocol at postoperative week 4, when baseline assessments will be performed; the intervention will begin immediately after baseline testing. The intervention consists of a 5-week concurrent exercise program combining aerobic and resistance training, delivered as two supervised in-person sessions per week (10 sessions total), approximately 60 minutes each, plus one autonomous home-based session per week guided by a written exercise plan provided by the responsible professional. Training progression will be individualized according to participant tolerance and safety parameters. Aerobic intensity will be monitored using the Borg Rating of Perceived Exertion scale, progressing from moderate levels at the beginning of the program to higher perceived exertion toward the final week. Resistance training loads will be prescribed using relative intensity based on one-repetition maximum (1RM) estimation and progressed weekly, focusing on major muscle groups and emphasizing controlled technique. Vital signs may be monitored as clinically appropriate before and after sessions and/or functional testing. The home-based session will be considered a complementary recommendation and will not be systematically recorded for adherence calculation. After completion of the 5-week intervention, participants will undergo a 1-week post-program period without supervised sessions (rest week). Post-intervention assessments will then be performed during the following week. Therefore, outcomes will be measured at two time points: baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest). Muscle quality will be assessed by musculoskeletal ultrasound of the rectus femoris using Philips Lumify, and images will be analyzed with ImageJ following a standardized approach to quantify parameters such as muscle thickness and metrics related to fat infiltration/echo intensity and cross-sectional area, according to the protocol used. Body composition will be evaluated using bioelectrical impedance analysis (InBody S10). Functional response will be measured using the One-minute Sit-to-Stand Test (1min-STST), recording repetitions and perceived exertion using the modified Borg scale; additional functional measures may include handgrip strength depending on the final protocol specification. Quality of life will be assessed as a secondary outcome using the Moorehead-Ardelt II questionnaire. Adherence will be assessed exclusively as attendance to the 10 supervised in-person sessions during the 5-week intervention period, calculated as: adherence (%) = (attended supervised sessions / 10) × 100. For descriptive purposes, adherence will be categorized as high (≥80%), moderate (60-79%), or low (\<60%). Statistical analyses will be conducted using SPSS. Data distribution will be assessed (e.g., Shapiro-Wilk), and within-subject pre-post changes will be analyzed using paired parametric or nonparametric tests as appropriate (paired t-test or Wilcoxon signed-rank test), with effect sizes estimated to support clinical interpretation. To explore associations, correlation analyses (Pearson or Spearman) will be used, and multivariable linear regression models will be constructed to examine the association between exercise adherence (continuous variable) and changes in primary outcomes; complementary analyses using adherence categories (high, moderate, low) will also be performed. Because bariatric surgery produces expected weight loss during the intervention period and this may influence outcomes independently of exercise, weight change will be included as a covariate in regression models, defined as Δweight (kg) = post-intervention weight - baseline weight, where negative values indicate weight loss. The results are expected to provide clinically relevant evidence on within-subject changes and on the association between adherence to an early concurrent exercise program and muscle-related outcomes (muscle quality), body composition, and functional recovery after bariatric surgery, contributing to optimization of postoperative metabolic rehabilitation strategies.

18-60 yearsAll GendersNA
1 location
A

RECRUITING

Since 2008, in France, certain university hospitals have been eligible to perform bariatric surgery for adolescents. It was therfore possible to define its feasibility, potential complications and specific indications. This led to recommandations published by Health Authorities (HAS) in 2016. However, it seems imperative to continue monitoring these patients in order to improve their management, especially as the use of these surgical techniques becomes increasingly widespread. The Angers University Hospital is one of the leading hospitals when it comes bariatric surgery for adolescents through its use of gastric bands. The aim of this protocol is to update data on how effective this surgery is on weight loss and obesity-associated comorbidities, and to monitor medical, psychological and surgical complications associated with this treatment.

14-20 yearsAll Genders
1 location
A

RECRUITING

The primary goal of the proposed study is to determine sex-related differences in the impact of Sleeve Gastrectomy (SG) on the pharmacokinetics (Aim 1), subjective effects (Aim 2), and glycemic effects (Aim 3) in the fasted versus prandial state when alcohol is ingested or given intravenously clamped (the gold standard to measure alcohol elimination rate and acute alcohol tolerance). We will use a cross-sectional study to compare participants who underwent SG surgery 1-5 years ago with matched non-operated controls (both sexes). This project will answer the questions of whether there are sex-related differences in the impact of SG on alcohol's pharmacokinetics and pharmacologic effects, whether drinking alcohol with a meal is effective post-SG, and clarify the site of alcohol first-pass metabolism in men. Findings from this study will contribute to evidence-based recommendations on the impact of SG on alcohol-related toxic effects and could help expand the knowledge base of sex-related differences in human alcohol pharmacokinetics.

21-64 yearsAll Genders
1 location

1-10 of 202

1