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NCT06407193
Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \[TWL\] \> 35%) and insufficient weight loss (TWL \< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.
NCT07451392
Pylorus-preserving pancreatoduodenectomy (PPPD) is a standard surgical treatment for tumors of the pancreatic head and surrounding areas. However, it is frequently associated with delayed gastric emptying (DGE), a complication that can lead to nausea, vomiting, and prolonged hospital stays. This study is a randomized controlled trial designed to evaluate if a simple intraoperative maneuver (pneumatic balloon dilatation of the pylorus) can reduce the incidence of early postoperative vomiting and DGE. Participants will be randomly assigned to either the intervention group, receiving pyloric dilatation during surgery, or the control group, receiving standard surgery without dilatation. Researchers will monitor postoperative symptoms, gastric emptying function, and overall recovery to determine if this maneuver effectively improves patient outcomes.
NCT07188571
Dear Patients, The investigators invite participants to take part in an observational study on gastric emptying rate in individuals with simple obesity. This study has been reviewed and approved by the Ethics Committee of Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. It will be conducted at Renji Hospital and is expected to enroll approximately 100 voluntary participants. Obesity has become a major global public health challenge. In 2020, an estimated 2.2 billion adults-42% of the global adult population-were affected by overweight and obesity. This number is projected to increase to 3.3 billion by 2035, representing 54% of adults worldwide. Obesity significantly compromises health and is associated with a range of metabolic disorders, including insulin resistance, atherogenic dyslipidemia (characterized by elevated triglycerides and low HDL cholesterol), nonalcoholic fatty liver disease (NAFLD), beta-cell dysfunction, prediabetes, and type 2 diabetes, all of which may lead to serious complications, disability, and premature death. Gastric emptying refers to the process by which food moves from the stomach into the duodenum. This process is essential for nutrient absorption and is regulated by gastric motility, as well as by neural and hormonal feedback mechanisms mediated by the interaction of nutrients with the small intestine. The rate of gastric emptying determines the pace at which nutrients reach the intestine and influences the enteral nutrient load. It also plays a bidirectional role in regulating blood glucose levels. Therefore, abnormal gastrointestinal motility may represent an important pathophysiological mechanism underlying insulin resistance and impaired glucose tolerance in obese individuals. To date, most studies on gastric emptying have focused on individuals with diabetes. However, as obesity itself is a major risk factor for metabolic diseases such as type 2 diabetes, further investigation into the distribution patterns of gastric emptying rates in individuals with simple obesity-and its associations with glucose and lipid metabolism, insulin resistance-could provide valuable insights. These insights may support improved diagnosis, risk stratification, and management of obesity-related metabolic disorders, as well as inform the evaluation of weight-loss interventions. The aim of this study is to assess gastric emptying velocity in patients with simple obesity and to explore its relationship with glucose and lipid metabolic indicators. This information sheet is intended to help participants decide whether they are willing to allow the use of their historical medical data for research and analysis. Participation in this study is entirely voluntary, and participants' decision will not affect their access to medical care or any of their rights as patients at Renji Hospital. Please be assured that, should participants choose to participate, the investigators will make every effort to protect their safety, privacy, and legal rights throughout the study, in full compliance with applicable ethical and legal standards. The investigators kindly ask participants to read this notice carefully. If participants have any questions or concerns, they are encouraged to speak with the investigator responsible for explaining the informed consent form.
NCT07407530
'Sip Til send' is a liberal drinking policy that replaces fasting before a caesarean delivery, meaning that women waiting in hospital can freely drink sips of water until they are called from the ward for their delivery. Studies has shown that 'Sip Til send' is safe and it improves the experience around surgery. Separate from this, drinking carbohydrate-rich drinks at specified time intervals before surgery is also recommended by international guidelines as part of a package of care aimed at enhancing recovery from surgery, and studies demonstrate that carbohydrate drinks significantly lower hunger sensation before caesarean delivery. The aim of this study is to combine these two interventions and compare the effects of sipping water against sipping carbohydrate drinks whilst waiting for a caesarean delivery and look at the stomach contents before delivery to ensure it is a safe practice and look at how women rate the quality of their recovery to see which practice is preferred. We will recruit women due to have an elective caesarean delivery whilst awake with a spinal anaesthetic at the Rotunda Hospital and only include those who are fully fasted on their arrival and would be candidates for the current 'Sip Til Send' policy. They will then be assigned to one of two groups, the "water" group who will be encouraged to sip water whilst waiting for surgery, and the "carbohydrate" group who will be encouraged to sip a standardised carbohydrate-rich drink instead. Using a bedside ultrasound machine, we will image the stomach and estimate the volume of liquid contents on two occasions; first, following recruitment to the study when fully fasted and before starting 'Sip Til Send', and second is immediately prior to surgery. Fluid intake will be closely monitored, and all participants will be asked to complete a short questionnaire the day after their delivery that asks them to rate aspects of their recovery. Participants and their newborns will not undergo any additional invasive testing for the study. Participants and their newborns will not undergo any additional invasive testing for the study, but consent will be sought to test women's urine for ketones (collected from the catheter bag during surgery). Medical notes will also be looked at after discharge to identify adverse outcomes such as nausea or vomiting during surgery and low blood sugar in the newborn. The study should run for approximately 3 to 6 months.
NCT05725967
This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.
NCT04229043
To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
NCT07214909
To determine the gastric emptying time for clear liquids at different volumes in the adult population, for use in determining anesthesia guidelines.
NCT03982836
The digestive process begins in the mouth and follows in the stomach and intestine. In the stomach the food is mixed with the gastric juices forming the chyme. To mix the food with the gastric juice as well as to provide gastric emptying (GE), the movements of the stomach are of great importance. Intestinal transit time is understood of the combination of GE, small intestine transit and colon transit time. The composition of the diet (lipid and protein content) exerts a direct influence on intestinal transit time due to the stimulation of hormone secretion, cholecystokinin and gastrin, respectively, which act to decrease GE velocity. In this context, it is also observed an important influence of dietary fibers on the speed of GE. Despite all knowledge about dietary fibers, information on such compounds still has many controversies. Due to the difficulty of finding compounds that fit into only one specific category (viscous, fermentable or prebiotic) there is difficulty in establishing a concept that best defines what are dietary fibers. The CODEX Alimentarius Commission in 2009 defined dietary fibers as carbohydrate polymers composed of ten or more monomer units of this macronutrient, which are not hydrolyzed by enzymes in the human intestine. Dietary fibers can be classified into insoluble and soluble according to the ability to bind to water molecules and form gels. Soluble fibers, especially those classified as prebiotic, in the intestine are fermented by bacteria giving rise to short chain fatty acids (SCFA). The SCFA stimulates the production and secretion of PYY and GLP-1 are associated with inhibition of gastric motility. Due to the importance of knowing the intestinal transit time, several methods have been developed, but scintigraphy is the gold standard technique for this analysis. Given the above and controversies present in the literature on the dietary fibers, there was a shortage of studies with the objective of evaluating the impact of different dietary fibers in intestinal transit time. This study shows relevant to help elucidate the behavior of different dietary fibers in intestinal transit time, offering data for correct and safe use of dietary fibers in various clinical situations. The hypothesis of this study is that the partially hydrolyzed guar gum delays the time of gastric emptying and intestinal transit, being this effect not observed for fructooligosaccharide
NCT07140289
This study aims to assess the effect of using Glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists on gastric emptying on surgical patients and whether specific guidelines need to be established for these patients. GLP-1 receptor agonists are mainly used for the treatment and mitigation of obesity and metabolic syndromes. One of their mechanisms of action is by delaying gastric emptying, hence increasing satiety. However, patients need to abstain from eating for a set amount of time before surgery to reduce the risk of aspiration. Hence patients who use GLP-1 receptor agonists may need more time to abstain eating (nil-per-os). In this study we aim to assess how much time is sufficient before surgery in these specific population of patients.
NCT07100691
This is a multicentre, investigator-blinded, randomised controlled trial evaluating whether the use of oral metoclopramide before surgery can reduce the amount of residual gastric content in patients who are taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for weight loss. These medications are known to slow down gastric emptying, which may increase the risk of pulmonary aspiration during anaesthesia. Patients will be randomly assigned to either receive metoclopramide 24 hours before surgery or continue with standard care. The primary outcome will be the presence or absence of residual gastric content on ultrasound before surgery. Secondary outcomes include nausea, vomiting, constipation, and any adverse effects of the medication.
NCT02665923
Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).
NCT06581120
The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.
NCT06606782
The aim of this prospective, observational study is to evaluate the incidence of residual gastric content in elective surgical patients who adhered to preoperative fasting guidelines and to investigate associated patient-related factors. Ultrasound (USG) has been identified as a valuable tool for assessing residual gastric content, and this study compares its efficacy against traditional questionnaire-based predictions. The study also examines the practicality and accuracy of different gastric volume estimation formulas and evaluates their correlation with aspiration risk. A total of 475 patients were enrolled in the study, of whom 404 completed both the questionnaire and USG examination. All participants were adult patients scheduled for elective surgery, following standard fasting protocols. The ultrasound examination assessed the presence of solid or fluid content in the stomach, and patients were classified according to qualitative Perlas risk scores (Grade 0: Low, Grade 1: Moderate, Grade 2: High risk of aspiration). The questionnaire collected patient-reported factors, such as symptoms of early satiety, history of cholelithiasis, and comorbidities like diabetes or chronic obstructive pulmonary disease (COPD). The primary objective of this study was to evaluate the efficacy of USG in detecting residual gastric content and compare it with questionnaire-based risk predictions. Logistic regression analysis identified early satiety and cholelithiasis as significant predictors of a full stomach and higher aspiration risk. Fasting duration was found to have a protective effect, reducing the likelihood of a full stomach. While many patient characteristics traditionally associated with delayed gastric emptying, such as age and diabetes, did not significantly correlate with the outcomes, early satiety and cholelithiasis proved to be key factors influencing gastric content. In addition, this study explored the performance of several gastric volume estimation formulas, including the Michiko, Bouvet, and Perlas 2019/2020 formulas. The findings indicated significant limitations in these formulas, with many patients being estimated to have negative gastric volumes, particularly by the Michiko and two of Perlas\&#39; formulas. This highlights the inadequacies of current formulas in accurately predicting gastric volume, necessitating further refinement and development of new models that better account for physiological variability. Furthermore, the agreement between questionnaire-based predictions and USG findings was assessed using Cohen's Kappa, which indicated fair agreement (Kappa value = 0.282). This suggests that while the questionnaire can serve as a screening tool to identify patients at risk of aspiration, it cannot replace the accuracy and reliability of USG in clinical practice. Secondary objectives of the study included comparing the time-efficiency and ease of implementation between USG and the questionnaire-based assessments. USG proved to be more time-efficient, taking an average of 2.5 minutes per examination, compared to 3-5 minutes for completing the questionnaire. This speed, combined with its objective nature, underscores USG's value as a practical tool in the preoperative setting. In conclusion, USG was found to be an effective and efficient tool for assessing residual gastric content and predicting aspiration risk, outperforming traditional questionnaire-based assessments. The inadequacy of current gastric volume estimation formulas points to the need for further research to develop more accurate and context-specific assessment tools. Comprehensive preoperative evaluation incorporating USG and patient-reported symptoms may improve patient safety by reducing the risk of aspiration during elective surgery.
NCT06038734
Given the increased prescription of GLP-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking GLP-1 agonists have an increased rate of delayed gastric emptying. The purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.
NCT05709197
The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.
NCT05436236
The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).
NCT05977244
The aim of this clinical trial is to investigate the effects of the meals moderated by fat and carbohydrate (CHO) quality along with varying macronutrient distribution (CHO: fat) on gut physiology and metabolic outcomes using the human postprandial model with healthy subjects. The main question\[s\] it aims to answer are: 1. How does meal composition with different polyunsaturated/saturated (P/S) ratio, glycemic index and macronutrient quantity affect lipemia and glycemia? 2. How does meal composition with different P/S ratio, Glycemic index and macronutrient quantity affect gastric emptying?
NCT02745028
Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.
NCT05657327
In recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. Although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.The definition and grading criteria of ISGPS on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic The study The main purpose of this study is to investigate the applicability of the ISGPS definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.
NCT05333237
Perioperative fasting is an essential patient safety measure to reduce the risk of pulmonary aspiration of gastric contents, a rare but potentially catastrophic complication of anesthetic and airway management. Anesthesiologists' concern about aspiration and the increasing awareness towards the negative impact of prolonged restriction of oral intake have shaped the current fasting guidelines. However, due to the perceived safety of prolonged fasting and practical considerations, adoption of the fasting guidelines is suboptimal. Gastric ultrasound is a quick, non-invasive method to evaluate gastric contents and aspiration risk. Gastric ultrasound can accurately discriminate between solid particles and fluid content, and mathematical models can reliably predict the volume of the gastric contents from the gastric antral area (GAA). This project aims to use gastric ultrasound to provide new data that can support management strategies in perioperative patients, that ensure both a low aspiration risk and an adequate nutritional support. The investigators will test the hypothesis that commercially available liquid meals can be safely used preoperatively. A pilot crossover, study on healthy volunteers will be conducted to determine the gastric emptying time of high-calorie drinks, as compared to clear fluid.