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NCT07461610
The goal of this observational study is to learn whether routine stool tests can detect changes in gut function 6 months after two common types of weight loss surgery: sleeve gastrectomy and gastric bypass (including mini gastric bypass and Roux-en-Y gastric bypass). The main questions it aims to answer are: Do stool tests show more signs of undigested food or carbohydrate malabsorption after gastric bypass compared to sleeve gastrectomy? Do signs of gut inflammation in stool (like fecal calprotectin) decrease after surgery, and does this relate to improvements in blood sugar and weight loss? Can simple stool test results at 6 months predict how much weight a person loses or how well their diabetes improves? Researchers will compare stool test results between the two surgery groups (sleeve gastrectomy vs. gastric bypass) to see if the type of surgery leads to different changes in gut health. Participants will: Provide a stool sample before surgery and again 6 months after surgery Provide a blood sample at the same time points to measure weight, blood sugar, and cholesterol Undergo their planned weight loss surgery as part of their regular medical care
NCT02731079
Sleeve gastrectomy is now the most commonly performed bariatric surgery. While many studies have evaluated factors that may minimize post-operative hemorrhage and staple-line leak, the investigators are unaware of any studies that compare outcomes between devices from the two main stapler manufacturers used in this surgery, Covidien and Ethicon. The purpose of this study is to compare intraoperative characteristics, such as time to create sleeve, intraoperative bleeding, and time needed to load each cartridge, and post-operative characteristics, such as any complication requiring readmission (leak or hemorrhage), further surgical intervention, and weight loss, between patients who underwent sleeve gastrectomy with Covidien devices and Ethicon devices. Currently the investigators predominantly use whatever device is cheaper, but cost should not be the primary decisive factor if one device is superior to the other. If one device has better clinical outcomes, it should be the preferred device regardless of cost. If neither proves superiority, the investigators can justify using cost to determine which device to use in patient care.
NCT07054138
This study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation, pneumoperitoneum, and opioid consumption in morbidly obese patients undergoing laparoscopic bariatric surgery.
NCT07032415
Obesity is a disease caused by many factors, such as lifestyle, eating habits, lack of physical activity, hormonal and genetic influences. These different factors make treatment planning difficult. Common treatments include changes in diet and lifestyle, medications, endoscopic methods (like balloon or botox), and surgery. No matter which method is used, the main goal is to help patients lose weight by creating a negative energy balance. To keep the weight off, patients need to maintain a balanced lifestyle in the long term. However, many treatments are not successful over time. One important part of long-term success is helping patients change their lifestyle and eating habits. A person's cognitive function may affect how they understand and follow these changes. Some studies show that a high body mass index (BMI) is linked to problems with thinking and memory. While weight loss may help improve brain function, the investigators don't yet know how early cognitive differences affect treatment results. At the obesity center in our hospital, morbidly obese patients receive support from a team of doctors, dietitians, psychologists, and physiotherapists. For at least three months, they attend individual and group sessions to help change their lifestyle and eating habits. This study aims to see how patients' cognitive function affects how much weight they lose by the end of the program.
NCT05783466
It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group). Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.
NCT05537883
To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.
NCT02937649
Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.
NCT06268990
This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects.
NCT04197336
The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.
NCT05710263
In patients with severe obesity, bariatric surgery provides consistent and long-term weight loss. BMI ≥50kg / m2 is an independent factor of increased morbidity / mortality in bariatric surgery compared with patients weighing less than 50 kg / m2 (1.2% and 0.8%) mainly due to technical difficulties. Preoperative weight loss reduces this morbidity / mortality. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss. The purpose of this study was to evaluate the safety and effectiveness of the association bariatric embolization before sleeve gastrectomy in super obese patients.
NCT06712199
The goal of this study is to elucidate the efficacy and safety of oxelidine combined with oligopiate anesthesia for multi-modal analgesia in weight-loss surgery in morbidly obese patients, and to discover a new strategy for multi-modal analgesia management in weight-loss surgery, laying a foundation for the widespread application of oligopiate anesthesia in special patients. A total of 124 patients who underwent elective bariatric surgery in our hospital were selected, and the participants were randomly divided into two groups: the opioid anesthesia group (OBA group) and the low-opioid anesthesia group (OFA group) using a random number table to achieve simple randomization. Inclusion criteria: 1.ASA grade I \~ III; 2. Age ≥18 years old; 3. Bariatric surgery patients with BMI≥35kg/m2 and complex signs of morbid obesity (such as metabolic syndrome) 4. Sign the informed consent form. Exclusion criteria: 1. Positive pregnancy test or breastfeeding; 2. Patients with a history of substance abuse or dependence on opioids; 3. Patients with chronic pain or with severe heart, lung, liver or nervous system diseases. Anesthesia implementation: 1. Routine monitoring after entry, intravenous administration of midazolam and atropine. Study participants were placed in the ramp position, bilateral recurrent laryngeal nerve block under ultrasound guidance, and the mouth contained dachronine gel. Radial artery puncture was performed and dexmedetomidine was injected intravenously. A laryngeal tube is used to test the sensation of the back of the oropharynx, and a laryngeal mask is placed while awake to connect the anesthesia circuit and deliver oxygen. Once the vocal cords are seen and the end-respiratory CO2 waveform is observed. 2\. The OBA group underwent combined anesthesia induction with propofol, rocuronium bromide and sufentanil, endotracheal intubation through visual laryngeal mask, intraoperative pump injection of propofol and remifentanil to maintain anesthesia, sufentanil bridging 10μg 30 minutes before the end of the operation; In OFA group, propofol, rocuronium bromide and esketamine were induced by combined anesthesia, and endotracheal intubation was performed through visual laryngeal mask. Intraoperative pump propofol and esketamine to maintain anesthesia; Oxeridine was bridged-1.5 mg 30min before the operation and administered in two doses, 0.75mg/ time, with an interval of 10min. 3\. Both groups were subjected to bilateral lower costal margin transversal nerve block under ultrasound guidance. 4\. Ondansetron was given before the end of the operation. After the operation, the tracheal cannula was removed under deep anesthesia, and the laryngeal mask was retained and transferred to the postoperative resuscitation room. Sugengosaccharide sodium was used to antagonize muscle pine during recovery. After the study participants were awake, the laryngeal mask was well tolerated. The laryngeal mask was removed after observation for 1h, and the laryngeal mask was safely transferred to the ward after continuous observation for 1h. PCA administration regimen in OBA group: Sufentanil + dexmedetomidine + Ondansetron; OFA group PCA administration regimen: oxelidine + dexmedetomidine + Ondansetron. Record the number of compressions, if the assessment of NRS≥4 points, then remedy 2mg oxycodone hydrochloride, and record the dosage. Main outcome measures: Consumption of oral morphine equivalent (OME) opioids in the 24 hours prior to surgery. Secondary outcome measures: Overall satisfaction with analgesia and Numerical Rating Scale (NRS, 0-10) pain score, area under the curve of resting and exercise NRS score (AUC) within 72 hours after surgery, time to first use of rescue analgesics within 72 hours, cumulative opioid consumption 72 hours after surgery (morphine milligram equivalent, morphine milligram equivalent, NRS score) MME), participants' satisfaction with postoperative analgesia, 15-item Quality of Recovery score Scale (QoR15) at 24, 48, and 72h after surgery, incidence of postoperative complications, incidence of nausea and vomiting, and incidence of adverse events were recorded.
NCT04235842
This study aims to determine the effect of two types of exercise training on body composition, cardiopulmonary function and quality of life in people after undergoing bariatric surgery.
NCT06032637
The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are: Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery. Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.
NCT06102538
Teenagers with body mass values (BMI) above 35 kg/m2 and co-morbidity are designated for medical disqualification from service in the IDF. Data show that there has been an increase in the incidence of these teenagers, specifically among the lower socioeconomic status. The purpose of this pilot study is to carry out an intervention Based lifestyle modification among a group of boys and girls with morbid obesity accompanied by a comorbidity that disqualifies them from service in the IDF. Definition of success: meeting the threshold of weight and health status that allows recruitment into the IDF. Criteria for finding candidates: * Boys and girls from the age of 15 who suffer from morbid obesity and comorbidity that may prevent their enlistment in the IDF. (This age range was chosen to allow an ideal period of at least one year to make a significant change). * Boys and girls who have their own and their family's willingness and commitment to participate in the process * A basic state of health that allows participation in the program. The screening process will be done by the staff of the endocrine unit, under the management of Prof. Orit Pinhas-Hamiel. Duration of intervention: 26 weekly sessions for the trainees. The duration of the meeting will be about three hours in the afternoon A decision whether to extend the duration of the intervention will be taken according to the initial results of the program. Activity location: Potential sites vary: Sheba// academic complex // military base for trainees. Number of participants - 25, (dropout expected 30%) Research goals (main content elements in the program) - there are 3 main content areas (of similar importance) * Education about the importance of service in the IDF and the opportunities inherent in it * Ability-adapted physical activity education and training * Guidance for a healthy diet * Psychological support \[The medical accompaniment to the program will take place on the basis of the patients' mother clinics and the medical follow-up of them will be done separately\].
NCT03429205
External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump. The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered. The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last \<2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.
NCT04128735
Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.
NCT05342922
This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section. The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.
NCT05680909
SaCo videolaryngeal mask airway is a novel third generation supraglottic device allowing for continuous observation of entrance to larynx via inserted in special channel videoscope connected with cable with external monitor. In obese patients airway management can be difficult so use of new devices that improve safety and potentially efficacy of airway management is indicated. In prospective observational study the SaCo VLM will be evaluated in terms of maintaining airway patency and effectiveness of intubation through it's lumen in morbidly obese scheduled for elective general surgery under general anesthesia.
NCT05670483
The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
NCT04980417
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients