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Tundra lists 11 Morbid Obesity Requiring Bariatric Surgery clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07813429
Changes in Cervical Posture, Cervical Function, and Neck Pain After Sleeve Gastrectomy
Obesity may contribute to neck pain, altered cervical posture, and impaired cervical function through increased mechanical loading, changes in body alignment, and reduced muscle performance. Although laparoscopic sleeve gastrectomy can produce substantial weight loss, its effects on cervical posture and neck-related function have not been studied comprehensively. This prospective, single-center study will include approximately 25 adults who are already scheduled to undergo laparoscopic sleeve gastrectomy as part of their routine clinical care. The decision to perform surgery and the surgical procedure itself will not be assigned or modified by the study. Participants will be evaluated before surgery and at 3, 6, and 12 months after surgery. Study assessments will include neck-related disability, neck pain intensity, quality of life, cervical range of motion, cervical muscle strength and endurance, and cervical joint position sense. Existing preoperative lateral cervical radiographs will be reviewed, and a lateral cervical radiograph will be obtained at the 12-month follow-up to assess cervical spinal alignment. The primary outcome will be the change in Neck Disability Index scores across the scheduled study assessments. The study aims to determine whether weight loss following laparoscopic sleeve gastrectomy is associated with changes in cervical posture, neck pain, and cervical function.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-09-28
1 state
NCT07100327
Banded Versus Non-Banded Sleeve in Class IV Obese Patients
Obesity remains a major global health challenge, with Class IV super obesity (BMI ≥ 50 kg/m²) being the most severe form. This condition is associated with numerous comorbidities including type 2 diabetes, hypertension, obstructive sleep apnea, and hyperlipidemia, which significantly reduce life expectancy and quality of life. Bariatric surgery, particularly sleeve gastrectomy (SG), has been shown to be an effective treatment for morbid obesity. While SG results in significant weight loss and improvement of comorbidities, some patients experience weight regain over time. Banded sleeve gastrectomy (BSG) has been proposed as a modification of SG to enhance long-term outcomes by providing additional restriction via a polypropylene band around the proximal gastric pouch. Although initial evidence for banded procedures suggests improved outcomes, particularly in the context of weight loss and reduced weight regain, specific evidence for Class IV obesity remains limited.
Gender: All
Ages: 18 Years - 60 Years
Updated: 2026-09-11
NCT07782281
Early Discharge With Hospital-at-Home After Bariatric Surgery and Economic Evaluation.
Bariatric surgery is the most effective treatment for severe obesity and its associated diseases. Advances in surgical techniques, enhanced recovery protocols, and multimodal perioperative care have made earlier hospital discharge possible while maintaining patient safety. This observational cohort study aims to evaluate the economic impact of an early discharge pathway consisting of 24 hours of hospital stay followed by Hospital-at-Home care, compared with the conventional 48-hour hospital stay after bariatric surgery. The study will compare healthcare costs, resource utilization, clinical safety, organizational efficiency, applicability of the early discharge pathway, and patient satisfaction between both postoperative care models under routine clinical practice.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-08-24
1 state
NCT07325916
Relationship Between Serum Apolipoprotein Levels and Weight Loss in Patients Undergoing Sleeve Gastrectomy for Morbid Obesity
The study looks at whether a specific protein in the blood, called apolipoprotein, can predict how much weight a person might lose after sleeve gastrectomy, a surgery for people with severe obesity. We want to find a specific level of this protein that shows which patients are most likely to lose weight successfully after surgery. By identifying this level, we hope to guide doctors in deciding who should have the surgery and who might do better with non-surgical weight loss methods.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-08-17
1 state
NCT07618598
SAPI vs SASI in the Management of Morbid Obesity
Study Design A single-center cohort study combining prospective and retrospective data collection was conducted. The prospective arm enrolled consecutively admitted patients, while the retrospective arm analyzed previously recorded cases meeting identical eligibility criteria. Study Setting and Population The study was performed at the General Surgery Department, Faculty of Medicine, Mansoura University. It included adults aged 18-65 years with morbid obesity eligible for bariatric surgery: * Body mass index (BMI) ≥ 35 kg/m² with obesity-related comorbidities, or * BMI 30-34.9 kg/m² with at least one major comorbidity \[e.g., type 2 diabetes mellitus (T2DM), hypertension (HTN), obstructive sleep apnea (OSA), dyslipidemia, osteoarthritis (OA), and gastroesophageal reflux disease (GERD)\] Study Period * Prospective: September 2021 - September 2023 * Retrospective: January 2017 - August 2021 Eligibility Criteria Included patients were American Society of Anesthesiology (ASA) class I-III and had failed structured non-surgical weight management for ≥6 months. Exclusion criteria included endocrine obesity, prior bariatric surgery, severe psychiatric or cognitive disorders, substance abuse, pregnancy, and previous major upper abdominal surgery. Sample Size Sample size was calculated based on cost difference between SASI and SAPI procedures using a two-sample means formula. A clinically relevant difference of 500 USD and SD of 700 USD were assumed, yielding: * Total of 62 patients in the entire cohort * Adjusted for 10% attrition → 70 total patients Final allocation was approximately 2:1 single anastomosis sleeve ileal bypass (SASI) : single anastomosis plication ileal bypass (SAPI), reflecting real-world recruitment rather than randomization. Group Allocation Non-randomized assignment was used. Prospective allocation involved shared decision-making within a multidisciplinary team, while retrospective allocation was based on prior surgical records. Influencing factors included cost, availability, insurance, and patient preference. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Methods Preoperative Assessment Comprehensive evaluation included: * Detailed medical history and comorbidity assessment * Nutritional deficiency screening and correction * Anthropometric measurements * Laboratory tests * Imaging (as indicated) Validated Questionnaires * Physical activity: using The Rapid Assessment of Physical Activity (RAPA) * Eating behavior: Self-Regulation of Eating Behavior Questionnaire (SREB-Q) and The Eating Attitudes Test (EAT-26) * Sleep quality: The Pittsburgh Sleep Quality Index (PSQI) * Socioeconomic status: Fahmy \& El-Sherbini scale * Quality of life (QoL): The Moorehead-Ardelt Quality of Life Questionnaire II (MA-QoL II) Surgical Procedures Two laparoscopic techniques were performed: SASI * Sleeve gastrectomy over 36-Fr bougie * 300 cm ileal loop anastomosed to gastric antrum * Stapled side-to-side stapled gastroileal anastomosis SAPI * Same, but gastric devascularization and plication over a 36-Fr bougie rather than sleeve gastrectomy Both procedures included leak testing, drain placement, and dual-outlet gastric configuration. Postoperative Management Standardized enhanced recovery protocol: * Early mobilization and VTE prophylaxis * Proton pump inhibitors and analgesia * Gradual oral intake from postoperative day 1 * Imaging and lab assessment when indicated * Early discharge if stable Cost Analysis A micro-costing approach was used, including: * Primary costs: technology, personnel, instruments, disposables, hospitalization, follow-up, supplements * Secondary costs: readmissions and re-interventions Cost components were calculated using standardized formulas for each item Total cost = Primary + Secondary costs Cost-effectiveness was evaluated using: * Cost-effectiveness ratios (CER) * Incremental cost-effectiveness ratio (ICER) * Outcomes included percentage of excess weight loss (%EWL), complication rates, readmission, comorbidity remission, and The Bariatric Analysis and Reporting Outcome System (BAROS). Follow-Up and Outcomes Follow-up included: * Weekly (1st month), biweekly (next 2 months), then quarterly (up to 1 year) * Assessment of weight loss, comorbidities, complications, and QoL Primary outcome: • Total cost difference between SASI and SAPI Secondary outcomes: * Operative time, length of hospital stay, complications * %EWL, comorbidity remission * QoL (MA-QoL II, BAROS) Statistical Analysis Performed using SPSS v26: * Normality: Shapiro-Wilk test * Continuous data: t-test or Mann-Whitney U * Categorical data: Chi-square or Fisher's test * Regression: linear and logistic models * Significance set at p \< 0.05.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-06-03
NCT07602959
Investigation of the Effects of Whole Body Vibration Application on Muscle Functional Level, Physical Fitness and Respiratory Parameters After Bariatric Surgery
The aim of this study was to investigate the effects of whole body vibration on muscle functional level, physical fitness and respiratory parameters after bariatric surgery. Hypotheses of the study: H1: TVV after bariatric surgery has an effect on the functional level of the muscle. H2: TVV after bariatric surgery has an effect on physical fitness. H3: TVV after bariatric surgery has an effect on respiratory parameters. H4: TVV after bariatric surgery has an effect on quality of life. H5: TVV after bariatric surgery has an effect on body composition. H6: TVV after bariatric surgery has an effect on biochemical parameters. Patients will be divided into 3 randomized controlled groups. Whole body vibration application group, resistance exercise group and control group. The whole body vibration group will exercise on the device 3 days a week. Resistance exercise group will exercise with resistance band 3 days a week. All exercises will last 6 weeks. The whole body vibration, resistance exercise and control groups will be recommended to walk 7 days a week.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-05-22
NCT07565051
Can Pre-operative Lean Mass Predict Weight Loss After Roux-en-Y Gastric Bypass?
The goal of this observational study is to evaluate whether preoperative fat-free mass predicts post-operative weight loss in patients undergoing Roux-En-Y gastric bypass. The primary objective of this study is to evaluate whether preoperative fat-free mass predicts weight loss in the two years following RYGB. The investigators will collect the following data, assessed as part of routine follow-up: * height, weight, hip and waist circumferences * body composition by bioimpedance analysis and dual energy-X-ray absorptiometry * Muscle strength and physical activity * Nutritional parameters: resting energy expenditure, eating behavior and digestive tolerance", plasma micronutrient status. . * Cardiovascular risk factors: fasting glucose, blood levels of Hb1Ac, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, blood pressure * Co-morbidities: joint pain and arthritis, sleep apnea, gastro-oesophageal reflux, metabolic dysfunction-associated fatty liver disease (MAFLD), cancer, stroke, heart attack. Quality of life: quality of life by the "Bariatric Analysis and Reporting Outcome (BAROS) questionnaire", symptoms of dumping syndrome by the "Sigstad diagnostic score system" Birthdate, birthweight and term of their children
Gender: All
Updated: 2026-05-08
1 state
NCT07564973
The Effect of Adiponectin-Leptin Ratio on Weight Loss in Patients Undergoing Sleeve Gastrectomy Due to Morbid Obesity
The study aims to find out if a specific blood test, measuring the balance between two hormones (adiponectin and leptin), can predict how much weight a person might lose after sleeve gastrectomy, a surgery for obesity. The investigators want to see if this hormone ratio can help identify who will benefit most from the surgery. If the investigators find that people with a low hormone ratio are less likely to lose weight after surgery, doctors can guide them toward other weight-loss options, like lifestyle changes or different treatments, instead of surgery. This way, patients can get the care that's best for them.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-05-07
1 state
NCT07564986
Relationship Between Serum Resistin Levels and Reduction in Visceral Fat in Patients Undergoing Sleeve Gastrectomy Due to Morbid Obesity
This study aims to investigate whether a specific protein in the blood, called resistin, can help doctors predict how much dangerous internal fat a patient will lose following weight loss surgery. Sleeve gastrectomy is a common and effective procedure that reduces the stomach's size to help patients lose weight and improve their metabolic health. Beyond just losing weight, it is vital to reduce visceral fat-the fat stored around internal organs-which is closely linked to inflammation and conditions like Type 2 Diabetes. Resistin is a marker known to contribute to insulin resistance and is typically higher in individuals with significant abdominal fat. By measuring resistin levels before surgery, we want to determine if this protein can serve as a guide to predict a patient's internal fat loss and overall metabolic recovery. Ultimately, this research could help healthcare providers better understand the hormonal changes that occur during weight loss and identify which patients may experience the most significant health improvements after the procedure.
Gender: All
Ages: 18 Years - 75 Years
Updated: 2026-05-04
1 state
NCT07073846
Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity. The main questions it aims to answer are: * Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)? * Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo? Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best. Participants will: * Receive an intravenous infusion of their assigned study drug(s) during surgery. * Provide three small blood samples (before surgery, immediately after, and three hours after). * Complete a short pain questionnaire (IPOQ) 24 hours after surgery.
Gender: All
Ages: 18 Years - 60 Years
Updated: 2025-11-28
1 state
NCT07087535
Midterm Follow up Outcomes of (SASJ) in Management of Morbid Obesity
Obesity is a critical health problem associated with an increased risk of cardiovascular disease, diabetes, and cancers, affecting both the quality of life and life expectancy . The increasing prevalence of obesity and comorbid conditions requires effective treatment and prevention . Previous evidence has demonstrated that bariatric surgery is associated with greater and longer-term weight loss than non-surgical management Thus, in patients with a body mass index of ≥ 40 or ≥ 35 kg/m2 with co-morbidities, bariatric surgery is the most effective treatment option that not only promotes weight loss but also improves comorbid conditions . However, like any surgical procedure, several complications can occur . The development of nutritional deficiencies is a complication which may be life-threatening; therefore, bariatric surgery requires careful consideration . The most frequently performed surgery for obesity worldwide is the laparoscopic sleeve gastrectomy (LSG), the Roux-en-Y gastric bypass (RYGB), and more recently, the one anastomosis gastric bypass (OAGB) . One newly developed weight loss procedure, the single sleeve ileal anastomosis bypass (SASI), has been developed as a modification to Santoro's operation (sleeve gastrectomy with transit bipartition SG + TB) . Since no duodenal division or manual anastomosis is required, the procedure allows easy endoscopic access to the duodenum . noted that SASI has the following advantages over other bariatric procedures: SASI has a shorter operative time compared to other procedures; 2) easy access to the duodenum and biliary tree endoscopically; 3) SASI does not divide the duodenum, thus eliminating the possibility of duodenal stump leakage, a serious complication with an incidence range between; 4) the tension on the anastomosis lower than other techniques; 5) there are no blind loops, excluded segments, or foreign bodies; 6) SASI is completely reversible . Single anastomosis sleeve jejunal (SASJ) bypass, which is the focus of this study, is a modification of SASI using a shorter biliopancreatic limb length compared to SASI to prevent long-term nutritional complications . The SASJ bypass appears to be safer than the SASI procedure in patients with excessive weight loss and nutritional deficiencies and is simpler due to its improved surgical ergonomics . Aim of the Work This study aims to evaluate the three-year outcomes of SASJ bypass as a primary bariatric procedure in a tertiary bariatric center for weight loss, comorbidity resolution, and both early and late complications.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2025-07-28