[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"General Committee of Teaching Hospitals and Institutes, Egypt\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":251},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,72,96,125,145,167,195,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100626467","comparing-revisional-laparoscopic-roux-en-y-gastric-bypass-versus-ringed-revisional-roux-en-y-gastric-bypass-after-laparoscopic-sleeve-gastrectomy-100626467",false,"NCT07436013","Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy","A Prospective Randomized Controlled Trial Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy: 5-Year Outcomes on Weight Loss, BAROS Score, Quality of Life, and Food Tolerance","Inclusion Criteria:\n\n* Adults aged 18-65 years.\n* Patients who experienced recurrent weight gain, suboptimal weight loss, or both within 12-24 months or more following sleeve gastrectomy.\n* Eligible and fit for bariatric surgery.\n* Willing to provide informed consent and adhere to follow-up.\n\nExclusion Criteria:\n\n* Severe psychiatric disorders or uncontrolled substance abuse.\n* Pregnancy or planned pregnancy within 2 years post-surgery.\n* Chronic steroid use or immunosuppressive therapy.\n* Active malignancy or history of gastrointestinal cancer.\n* Severe cardiac or pulmonary disease precluding surgery.\n* Uncontrolled endocrine disorders (other than T2DM).\n* Inability to comply with follow-up or protocol requirements.","ALL","18 Years","65 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","Obesity remains a major global health challenge, with rising prevalence and significant metabolic, cardiovascular, and gastrointestinal comorbidities. Laparoscopic sleeve gastrectomy (LSG) has emerged as the most widely performed bariatric procedure due to its technical simplicity and satisfactory short- to mid-term results. However, a proportion of patients experience suboptimal weight loss, recurrent weight gain, or both.\n\nIn this study, patients with recurrent weight gain of maximum weight loss or suboptimal weight loss or both following sleeve gastrectomy were included.\n\nSuboptimal weight loss is defined as total weight loss (TWL) of less than 20% of the preoperative weight and\u002For excess weight loss (EWL) of less than 50%, measured at least 12-18 months after the primary sleeve gastrectomy.\n\nRecurrent weight gain after sleeve gastrectomy is defined as an increase of ≥20% of the maximum weight loss (from nadir weight) or an increase in BMI of \\>5, measured at least 24 months after the primary procedure.",[27],"Revisional Bariatric Surgery",[29,30,31,32,33,34,35],"Gastric Bypass","Revisional Laparoscopic Roux-en-Y","Ringed Revisional Roux-en-Y","Weight Loss","BAROS Score","Quality of Life","Food Tolerance","RECRUITING","2026-04-24",{"date":39,"type":40},"2026-04-29","ACTUAL",{"date":42,"type":40},"2026-03-15",{"date":44,"type":21},"2031-03",{"name":46,"class":47},"General Committee of Teaching Hospitals and Institutes, Egypt","OTHER_GOV",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100627458","alterations-in-mast-cell-and-macrophage-infiltration-as-well-as-micro-vessel-density-100627458","NCT07448896","Alterations in Mast Cell and Macrophage Infiltration, as Well as Micro Vessel Density","Understanding Alterations in Mast Cell and Macrophage Infiltration, as Well as Micro Vessel Density, May Throw Light on the Early Events Leading to Gastric Carcinogenesis in Obesity","Inclusion Criteria:\n\n* Adult patients undergoing bariatric surgery (laparoscopic sleeve gastrectomy).\n* BMI \\> 35 kg\u002Fm²\n* All participants underwent preoperative evaluation, including blood tests and assessment by a multidisciplinary team (nutritionist, psychiatrist, endocrinologist, radiologist, anesthesiologist, and surgeon).\n\nExclusion Criteria:\n\n* Patients with secondary causes of obesity, such as Cushing's syndrome or polycystic ovary syndrome (PCOS).\n* Patients with malignant gastric conditions or previous gastric surgery.\n* Patients with systemic inflammatory diseases, autoimmune disorders, or chronic infections that may influence immune cell infiltration.\n* Patients with incomplete clinical data or poor-quality tissue samples.\n* Patients taking anti-inflammatory, immunosuppressive, or corticosteroid therapy within the last 3 months before sampling.",{"count":57,"type":21},100,"OBSERVATIONAL","Obesity is a global health problem that has reached epidemic proportions, affecting more than one billion people worldwide and significantly increasing the risk of multiple comorbidities, including type 2 diabetes, cardiovascular diseases, and cancer (World Health Organization, 2024). Increasing evidence suggests that chronic low-grade inflammation associated with obesity plays a critical role in the development of obesity-related malignancies, including gastric cancer. Adipose tissue dysfunction in obesity leads to the recruitment and activation of various immune cells, such as macrophages and mast cells, which contribute to a pro-inflammatory microenvironment through the release of cytokines, growth factors, and angiogenic mediators.",[61],"Obesity",[63,64,65],"gastric carcinogenesis","immunopathological changes","gastric mucosa",{"date":39,"type":40},{"date":68,"type":40},"2026-04-15",{"date":70,"type":21},"2026-05",{"name":46,"class":47},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":48},"100610683","bougie-diameter-on-outcomes-in-laparoscopic-sleeve-gastrectomy-100610683","NCT07230769","Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy","Impact of Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy - A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adult patients aged between 18 and 70 years undergoing LSG as a primary bariatric procedure\n2. Body mass index (BMI) criteria according to 2022 ASMBS\u002FIFSO guidelines:\n\n   * BMI ≥35 kg\u002Fm² regardless of presence, absence, or severity of comorbidities, OR\n   * BMI 30-34.9 kg\u002Fm² (Class I obesity) with metabolic disease and inadequate response to nonsurgical methods, including:\n\n     * Type 2 diabetes mellitus\n     * Arterial hypertension\n     * Dyslipidemia\n     * Obstructive sleep apnea syndrome and other severe respiratory disorders\n     * Cardiovascular disease (coronary artery disease, heart failure, atrial fibrillation)\n     * Asthma\n     * Fatty liver disease and nonalcoholic steatohepatitis\n     * Chronic kidney disease\n     * Polycystic ovarian syndrome\n     * Infertility\n     * Pseudotumor cerebri\n     * Bone and joint diseases\n3. Decision for bariatric surgery approved after multidisciplinary team discussion\n4. Written informed consent obtained\n5. Ability to complete questionnaires and attend follow-up visits\n6. Stable weight (±5% for 3 months before surgery)\n7. Normal preoperative upper gastrointestinal endoscopy or findings limited to:\n\n   * Los Angeles (LA) Classification Grade A reflux esophagitis (minimal mucosal breaks \\\u003C5mm)\n   * Mild gastritis without active ulceration\n8. Negative or minimal gastroesophageal reflux symptoms (GERD-Q score ≤8)\n\nExclusion Criteria:\n\n1. History of previous gastric surgeries or bariatric procedures\n2. American Society of Anesthesiologists (ASA) score \\>4\n3. Ongoing pregnancy or planned pregnancy within the study period\n4. Significant esophageal and gastric pathology, including:\n\n   * Los Angeles (LA) Classification Grade B, C, or D reflux esophagitis\n   * Hiatal hernia or any paraesophageal hernia\n   * Barrett's esophagus of any length\n   * Active peptic ulcer disease\n   * Gastric polyps \\>1cm or suspicious lesions\n5. Severe gastroesophageal reflux disease is defined as:\n\n   * GERD-Q score \\>8\n   * Daily proton pump inhibitor (PPI) dependency with breakthrough symptoms\n   * Endoscopic evidence of LA Grade B, C, or D esophagitis\n6. Coagulation disorders or anticoagulation therapy that cannot be safely discontinued\n7. Known silicon hypersensitivity or allergies to bougie materials\n8. Active substance abuse or psychiatric conditions that may impair compliance","70 Years",{"count":57,"type":21},[24],"Laparoscopic sleeve gastrectomy (LSG) has become an increasingly popular bariatric procedure since its first performance by Hess and Hess in 1988 as a component of the biliopancreatic diversion-duodenal switch (BPD-DS) procedure, which was modified from Scopinaro's biliopancreatic diversion (BPD) and DeMeester's technique. In the early part of the twenty-first century, it was popularized as a first-step intervention before BPD or gastric bypass in the super obese and high-risk group of patients by Regan et al. Due to the unexpected good results in terms of weight loss and resolution of comorbidities, coupled with the simplicity of performing the procedure requiring intervention on only the stomach, sleeve gastrectomy gained status as a stand-alone bariatric procedure as demonstrated by Baltasar et al.\n\nThe basic principle of LSG is to create a narrow stomach along the lesser curvature, depending on the left gastric artery, using a calibration bougie as a template to perform a vertical partial gastrectomy, resecting the greater curvature and fundus of the stomach according to the International Sleeve Gastrectomy Expert Panel Consensus Statement by Rosenthal et al. The procedure has demonstrated excellent outcomes in terms of weight loss and comorbidity resolution, making it one of the most commonly performed bariatric procedures worldwide according to the IFSO Worldwide Survey by Angrisani et al.\n\nBougie Size Considerations and Rationale The selection of an appropriate bougie size during laparoscopic sleeve gastrectomy represents a critical technical decision that significantly influences both immediate surgical outcomes and long-term patient results. Calibration bougies serve as internal templates to standardize the gastric sleeve diameter and ensure consistent sleeve geometry across different surgeons and institutions, as described by Parikh et al.\n\nThe diameter of the bougie directly determines the final gastric volume and the degree of restriction achieved, which in turn affects weight loss efficacy, food tolerance, and complication rates.\n\nBougie sizes in current clinical practice typically range from 32-French (Fr) to 50-Fr, with most centers utilizing sizes between 34-Fr and 42-Fr according to the survey by Gagner et al. Small bougie sizes (32-36-Fr) create a more restrictive sleeve with potentially enhanced weight loss but may be associated with increased risks of stenosis, food intolerance, and gastroesophageal reflux disease as reported by Sakran et al.\n\nMedium bougie sizes (38-42-Fr) represent a compromise between restriction and safety, offering adequate weight loss while maintaining acceptable complication rates as demonstrated by Weiner et al. Large bougie sizes (44-50-Fr) provide greater sleeve capacity with improved food tolerance and potentially reduced leak rates, though concerns exist regarding long-term weight loss maintenance according to Abdallah et al.\n\nThe rationale for comparing different bougie sizes stems from the ongoing debate regarding the optimal balance between surgical efficacy and safety. Recent meta-analyses have suggested that larger bougie sizes may be associated with reduced gastric leak rates without significantly compromising weight loss outcomes. However, the majority of existing evidence comes from retrospective observational studies with inherent limitations including selection bias, confounding variables, and lack of standardized outcome measures as noted by Shi et al. The current study aims to provide definitive prospective evidence comparing small (36-Fr) versus X large (larger than 40-Fr) bougie sizes in a randomized controlled trial design.\n\nFurthermore, the impact of bougie size on comorbidity resolution remains inadequately studied. Bariatric surgery has demonstrated remarkable efficacy in resolving obesity-related comorbidities, with diabetes remission rates ranging from 53% to 63% as reported by Schauer et al. and hypertension resolution rates varying from 8% to 50% depending on the specific criteria used according to Sjöström et al. The relationship between sleeve geometry, as determined by bougie size, and comorbidity resolution mechanisms requires further investigation to optimize patient outcomes and surgical technique selection.",[84],"Bariatric Sleeve Gastrectomy",[86,87],"Bougie Diameter","Outcomes in Laparoscopic Sleeve Gastrectomy","2026-02-14",{"date":90,"type":40},"2026-02-18",{"date":92,"type":40},"2026-02-15",{"date":94,"type":21},"2026-12",{"name":46,"class":47},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":48},"100594570","phase-4-trial-comparing-elan-specialized-bariatric-supplements-with-standard-multivitamins-in-patients-undergoing-bariatric-procedures-100594570","NCT07021170","Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Bariatric Procedures","A Double-Blinded Randomized Controlled Trial Comparing Elan Specialized Bariatric Supplements With Standard Multivitamins in Patients Undergoing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, and One-Anastomosis Gastric Bypass","Inclusion Criteria:\n\nEligible participants must be adults:\n\n* Aged 18 to 65 years\n* Capable of providing informed consent\n* Willing to comply with study procedures and follow-up visits over 12 months.\n* Candidates must have no prior history of MBS or gastrointestinal surgery and must be scheduled for one of the three aforementioned primary procedures.\n* Both male and female patients will be considered, and no restrictions will be placed based on ethnicity or socioeconomic status.\n\nExclusion Criteria:\n\nExclusion criteria include:\n\n* The presence of chronic conditions that may independently affect micronutrient metabolism or absorption, such as chronic kidney disease, inflammatory bowel disease, or hepatic insufficiency.\n* Additional exclusion criteria include pregnancy or lactation at the time of enrollment\n* Plans for pregnancy within the study period\n* Active malignancy\n* Any use of investigational drugs or supplements within the past 30 days.\n* Patients undergoing revisional bariatric surgery or conversion procedures will also be excluded.",true,{"count":105,"type":21},624,[107],"PHASE4","Obesity has escalated to pandemic levels, impacting over 650 million adults globally and significantly contributing to the burden of non-communicable diseases such as type 2 diabetes, cardiovascular disease, obstructive sleep apnea, non-alcoholic fatty liver disease, and infertility. The chronic, multifactorial nature of obesity presents substantial challenges for long-term management, as lifestyle modifications and pharmacotherapy often yield limited and transient success. In this context, Metabolic and bariatric surgery (MBS) has emerged as the most effective and enduring treatment for obesity, offering significant weight loss and marked improvement or remission of obesity-related comorbidities.\n\nThe most prevalent MBS procedures include sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). While these interventions offer considerable metabolic advantages, they inherently cause significant modifications to gastrointestinal anatomy and physiology, which can predispose patients to long-term micronutrient deficiencies. These deficiencies can stem from reduced dietary intake, altered gastric acid secretion, decreased intrinsic factor production, and the bypassing of critical absorptive sites in the gastrointestinal tract. Commonly affected nutrients encompass iron, vitamin B12, Vitamin B6, folate, vitamin D, calcium, and zinc. If not effectively managed, these nutrient deficiencies can lead to anemia, secondary hyperparathyroidism, osteopenia, neurological complications, immune dysfunction, and impaired postoperative recovery.\n\nPopulation-based recommended dietary allowances (RDAs) and tolerable upper intake levels (ULs) tend to underestimate the nutritional requirements for postoperative patients, as they are derived from healthy cohorts. Many standard formulations may fall short due to inadequate dosages, non-bioavailable forms, or poor tolerability, which can significantly impact patient adherence to supplementation regimens. Over-the-counter multivitamins, such as Centrum®, are designed for the general population and often lack the dosing, bioavailability, or elemental forms required for post-MBS physiology, particularly following bypass procedures.\n\nThe American Society for Metabolic and Bariatric Surgery (ASMBS) recommends 8-22 mg of elemental zinc per day, depending on the procedure, and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the World Gastroenterology Organization (WGO) recommend up to 30 mg\u002Fday for OAGB patients. These values are below the national upper limit in Egypt, which is 25 mg\u002Fday.\n\nMoreover, there is evidence indicating a discrepancy in nutrient deficiencies among different bariatric surgery patients; for instance, OAGB patients exhibit a greater prevalence of iron and zinc deficiencies compared to those undergoing RYGB or SG, thereby necessitating proportionally higher supplementation tailored to their specific needs.",[110],"Vitamin Deficiencies",[112,113,114,115,116],"Elan Specialized Bariatric Supplements","Standard Multivitamins","Sleeve Gastrectomy","Roux-en-Y Gastric Bypass","One-Anastomosis Gastric Bypass","2025-09-10",{"date":119,"type":40},"2025-09-16",{"date":121,"type":40},"2025-06-15",{"date":123,"type":21},"2026-06",{"name":46,"class":47},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":144,"locationsCount":48},"100594576","phase-4-a-randomized-controlled-trial-evaluating-the-impact-of-procedure-specific-bariatric-supplements-on-micronutrient-status-and-vitamin-b6-hypervitaminosis-following-metabolic-and-bariatric-surgery-100594576","NCT07021248","A Randomized Controlled Trial Evaluating the Impact of Procedure-Specific Bariatric Supplements on Micronutrient Status and Vitamin B6 Hypervitaminosis Following Metabolic and Bariatric Surgery","Inclusion Criteria:\n\nEligible participants will be adults:\n\n* Aged 18 to 65 years\n* Undergoing primary metabolic and bariatric surgery (MBS), including sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), or one anastomosis gastric bypass (OAGB).\n* Patients must meet established surgical indications as defined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), specifically: a body mass index (BMI) greater than 30 kg\u002Fm² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea)\n* or a BMI greater than 35 kg\u002Fm² irrespective of comorbidities.\n* Eligible participants must be capable of providing informed consent, willing to adhere to the prescribed supplement regimen, and able to complete scheduled postoperative follow-up visits for 12 months.\n\nExclusion Criteria:\n\nExclusion criteria include:\n\n* Revision or secondary MBS procedures\n* Known hypersensitivity to vitamin B6 or any component of the supplement formulations\n* Pregnancy or planned pregnancy during the study period\n* Any pre-existing medical condition known to interfere with vitamin B6 metabolism. This includes, but is not limited to, severe hepatic or renal dysfunction, peripheral neuropathy, and the use of medications such as isoniazid, phenytoin, or levodopa. Additional exclusions include chronic gastrointestinal conditions affecting absorption (e.g., inflammatory bowel disease, celiac disease), porphyria, or any other clinical scenario that, in the judgment of the investigators, may compromise compliance or the reliability of follow-up.\n* Patients who are already receiving high-dose vitamin B6 supplementation or have abnormal preoperative B6 levels will be excluded.",{"count":132,"type":21},249,[107],"Obesity is a complex, multifactorial chronic disease with an escalating global incidence, impacting over 650 million adults worldwide. It is closely linked to a variety of metabolic, cardiovascular, and musculoskeletal diseases, and is a leading contributor to preventable morbidity and mortality. Metabolic and Bariatric Surgery (MBS) stands out as the most effective long-term intervention for obesity, facilitating significant and sustained weight loss while also promoting remission of associated diseases.\n\nHowever, the anatomical and physiological alterations induced by MBS, including gastric restriction, bypass of absorptive surfaces, altered gastrointestinal transit, and reduced gastric acid production, significantly disrupt nutrient absorption and metabolism, placing patients at lifelong risk of micronutrient deficiencies or, conversely, hypervitaminosis resulting from excessive supplementation. Among these, Vitamin B6 imbalance has emerged as a significant yet under-recognized issue in post-MBS patients.\n\nAmong the nutrients affected, vitamin B6 (pyridoxine) presents a unique challenge. Vitamin B6 functions as a coenzyme in amino acid metabolism, neurotransmitter synthesis, and immune regulation. Deficiencies in Vitamin B6 are well-documented and can manifest as glossitis, irritability, and peripheral neuropathy. Notably, B6-related neuropathy may clinically resemble Guillain-Barré syndrome in post-MBS patients. This anxiety surrounding deficiency symptoms often leads to the overconsumption of Vitamin B6, resulting in hypervitaminosis, which can also present with neurological manifestations such as sensory neuropathy and ataxia.\n\nThe risk of hypervitaminosis is further exacerbated by the widespread use of high-dose multivitamin formulations post-surgery, many of which contain vitamin B6 at levels far exceeding the Recommended Dietary Allowance (RDA). For males, the RDA is 1.3 mg daily for those aged 19-50 years, increasing to 1.7 mg for those over 50. For females, the RDA is 1.3 mg for those aged 19-50 and 1.5 mg for those over 50. Yet some commercially available bariatric supplements exceed this level several-fold. Studies by Dogan et al. and Homan et al. emphasize the prevalence of vitamin B6 toxicity in post-MBS populations, largely attributable to inappropriate supplementation practices.",[136],"Micronutrient Status",[138,136,139,140],"Procedure-Specific Bariatric Supplements","Vitamin B6 Hypervitaminosis","Metabolic and Bariatric Surgery",{"date":119,"type":40},{"date":121,"type":40},{"date":123,"type":21},{"name":46,"class":47},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":103,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":166,"locationsCount":48},"100591554","phase-4-this-randomized-trial-aims-to-investigate-the-efficacy-of-balanced-nutritional-tablets-comprehensive-multivitamin-and-mineral-supplements--in-preventing-micronutrient-deficiencies-among-patients-utilizing-glp-1-ras-for-weight-loss-in-comparison-to-a-placebo-control-100591554","NCT06981936","This Randomized Trial Aims to Investigate the Efficacy of Balanced Nutritional Tablets-Comprehensive Multivitamin and Mineral Supplements- in Preventing Micronutrient Deficiencies Among Patients Utilizing GLP-1 RAs for Weight Loss in Comparison to a Placebo Control","Evaluation of Balance Tablets in Reducing Vitamin and Mineral Deficiencies in Patients Using GLP-1 Receptor Agonists for Weight Loss","Inclusion Criteria:\n\n* • Adults aged 18-65 years.\n\n  * BMI ≥ 30 kg\u002Fm² (obesity), or BMI ≥ 27 kg\u002Fm² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension).\n  * Currently using a GLP-1 receptor agonist medication for weight management (e.g., semaglutide or liraglutide) and planning to continue it for the next year as part of their weight loss regimen.\n\nExclusion Criteria:\n\n* • Any pre-existing condition that affects nutrient absorption or metabolism (e.g., malabsorptive gastrointestinal disorders such as celiac disease or inflammatory bowel disease, prior bariatric surgery).\n\n  * Use of other weight loss medications (besides the GLP-1 RA) or use of high-dose vitamin\u002Fmineral supplements or other nutritional supplements that could influence vitamin\u002Fmineral status.\n  * Pregnancy or lactation (women of childbearing potential will undergo a pregnancy test and must agree to use contraception during the study).\n  * Known hypersensitivity or allergy to components of the Balance multivitamin formulation.\n  * Significant chronic illnesses (e.g., end-stage renal disease, advanced liver disease) that in the investigator's judgment would interfere with participation or outcomes of the study.",{"count":153,"type":21},150,[107],"Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including Ozempic (semaglutide) and Saxenda (liraglutide), are gaining traction in treating obesity and its associated diseases due to their capacity to facilitate substantial weight loss through mechanisms such as appetite suppression and delayed gastric emptying. Clinical trials have consistently shown that patients prescribed GLP-1 RAs can achieve significant body weight reductions when combined with appropriate dosing and lifestyle modifications.\n\nHowever, the chronic appetite suppression and reduced caloric intake associated with prolonged GLP-1 RA use may increase the risk of micronutrient deficiencies, paralleling the biochemical changes observed after metabolic and bariatric surgery (MBS). In MBS cohorts, insufficient dietary intake coupled with malabsorption frequently results in deficiencies of essential vitamins and minerals, even in patients adhering to standard multivitamin regimens.\n\nResearch has demonstrated that high-dose specialized multivitamin supplementation can substantially lower the incidence of postoperative micronutrient deficiencies in MBS patients. This raises the possibility that proactive nutrient supplementation might similarly benefit individuals undergoing weight loss with GLP-1 RAs, although this hypothesis remains to be empirically validated.\n\nTo address this gap, this randomized trial aims to investigate the efficacy of Balanced nutritional tablets-comprehensive multivitamin and mineral supplements- in preventing micronutrient deficiencies among patients utilizing GLP-1 RAs for weight loss in comparison to a placebo control. Moreover, the study will assess changes in key nutrient biomarkers and relevant clinical outcomes over 12 months.",[157],"Micronutrient Deficiencies",[159,160,161,32,157],"Balance Tablets","Vitamin and Mineral Deficiencies","GLP-1 Receptor Agonists for Weight Loss",{"date":119,"type":40},{"date":164,"type":40},"2025-05-15",{"date":70,"type":21},{"name":46,"class":47},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":103,"sex":16,"minAge":17,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":184,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":48},"100486030","conversion-to-sadi-s-rygb-or-oagb-after-failed-sleeve-100486030","NCT05608772","Conversion to SADI-S, RYGB or OAGB After Failed Sleeve","Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB","RCTresleeve","Inclusion Criteria:\n\n* Undergone primary laparoscopic sleeve gastrectomy in the past\n* Weight regain\n\n  * defined as any increase in weight above the nadir as reported by the patient\n  * BMI at the time of revisional surgery was around 45 kg\u002Fm2\n  * weight regain was defined as an increase in BMI after bariatric surgery to exceed 35\n* With or without Gastroesophageal reflux disease (GERD) grade A and B o Patients with grade C or higher GERD, according to the Los Angeles (LA) classification \\[7\\] will be excluded from the study\n\nExclusion Criteria:\n\n* Didn't follow preoperative consultation\n* Cannot give of sign informed consent","60 Years",{"count":177,"type":21},234,[24],"Assess what revisional surgery is superior and provides the best weight loss after primary LSG. What is the occurrence of complications and the nutritional laboratory status? And if the resolution and \u002For improvement of associated medical problems after the weight loss will occur.",[32,181,182,183],"Bariatric Surgery Candidate","Comorbidities and Coexisting Conditions","Nutrient Deficiency",[185,186,187,188],"RYGB","OAGB","SADI-S","Sleeve gastrectomy",{"date":119,"type":40},{"date":191,"type":40},"2023-03-15",{"date":193,"type":21},"2028-04-15",{"name":46,"class":47},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":103,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":211,"overallStatus":215,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100555312","antibiotic-prophylaxis-in-metabolic-bariatric-surgery-100555312","NCT06510452","Antibiotic Prophylaxis in Metabolic Bariatric Surgery","Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n° Patients must be older than 18 and meet the eligibility criteria for MBS as outlined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the Dutch Federation of Medical Specialists for the surgical treatment of obesity.\n\nExclusion Criteria:\n\n* Patients undergoing immunotherapy or corticosteroid treatment for Crohn's disease or rheumatoid arthritis.\n* Patients with a history of endocarditis require prophylactic antibiotics.\n* Patients with known severe allergies to antibiotics.\n* Patients with active infections or recently treated with antibiotics (within the last 30 days).\n* Patients with compromised immune systems, including those with HIV\u002FAIDS or undergoing chemotherapy.\n* Patients with chronic liver or kidney disease.\n* Patients with uncontrolled diabetes (HbA1c \\> 9%).\n* Patients with a history of previous metabolic bariatric surgery.\n* Pregnant or breastfeeding women.\n* Patients with any other medical condition that, in the opinion of the investigator, would compromise the patient's safety or the study's integrity.",{"count":203,"type":21},3352,[24],"SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable.\n\nObjective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections.\n\nStudy Design: Randomized controlled trial (RCT), double-blind.\n\nStudy Population: Patients with obesity eligible for MBS.\n\nIntervention:\n\n* Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs).\n* Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision.\n\nMain Study Parameters\u002FEndpoints: Compare the incidence of incisional and organ\u002Fspace SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.",[207,208,209,181,210],"Antibiotic Reaction","Wound Infection Superficial","Wound Infection Deep","Complication,Postoperative",[212,213,214],"anti-biotics","non-inferiority","surgical side infection","NOT_YET_RECRUITING","2024-07-29",{"date":218,"type":40},"2024-07-31",{"date":220,"type":21},"2024-10-01",{"date":222,"type":21},"2026-04-01",{"name":46,"class":47},2,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":103,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":215,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":48},"100519915","d2-versus-d3-dissection-in-laparoscopic-right-hemicolectomy-100519915","NCT06049758","D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy","D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy In Right Cancer Colon Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with right-side colon cancer (caecum, ascending, or hepatic flexure)\n* Diagnosed by CT entero-colonography\n* Diagnosed by colonoscopy\n* Diagnosed by biopsy.\n\nExclusion Criteria:\n\n* Emergency surgery (obstruction, perforation with generalized peritonitis),\n* Metastatic tumor diagnosed\n* ASA score of IV or higher\n* Need for more than one surgical procedure\n* Conversion to open surgery",{"count":233,"type":21},80,[24],"Evaluating the differences between D2 and D3 lymphadenectomy in laparoscopic right hemicolectomy in patients with right cancer colon post-operative outcome, intra-operative blood transfusion, post-operative ICU admission, anastomotic leakage, lymph node harvesting in the final specimen, and six months follow up and overall survival time after 5-years",[237,238,239,240,241,242],"Blood Loss","Intensive Care","Anastomotic Leakage","Lymph Node Disease","Survival","Blood Transfusion","2023-09-19",{"date":245,"type":40},"2023-09-22",{"date":247,"type":21},"2024-01-02",{"date":249,"type":21},"2030-01-02",{"name":46,"class":47},""]