[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mater Misericordiae University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100600684","phase-4-gastric-emptying-with-metoclopramide-in-glp-1-agonist-patients-undergoing-elective-surgery-100600684",false,"NCT07100691","Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery","Preoperative Metoclopramide to Enhance Gastric Emptying in Patients on Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss: A Randomised Controlled Trial With Ultrasound Assessment","GEM-GLP1RA","Inclusion Criteria:\n\n* Patients taking GLP-1 receptor agonists (for weight loss only)\n* Male and female patients aged 18 years or older\n* Able to provide written informed consent\n* ASA grade I-V\n* Scheduled for elective surgery with an expected overnight hospital stay\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Presence of hiatus hernia\n* History of any gastric surgery\n* Pregnancy\n* Inability to lie in the right lateral decubitus position\n* Patients taking chronic opioids\n* Poorly controlled diabetes (HbA1c \\>69 mmol\u002Fmol)\n* Urgent or emergency surgery, including trauma\n* Diagnosis of Parkinson's disease\n* Allergy or intolerance to metoclopramide","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","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.",[27,28,29,30],"Pulmonary Aspiration During Anaesthetic Induction","Gastric Emptying Time","Preoperative Risk Assessment","Obesity (Disorder)",[32,33,34,35,36,37,38,39,40,41],"GLP-1 Receptor Agonist","Metoclopramide","Elective Surgery","Residual Gastric Content","Gastric Ultrasound","Aspiration Risk","Perioperative Management","Obesity Medications","Randomised Controlled Trial","Anaesthesia Safety","NOT_YET_RECRUITING","2025-08-01",{"date":45,"type":46},"2025-08-06","ACTUAL",{"date":48,"type":21},"2025-08",{"date":50,"type":21},"2026-06",{"name":52,"class":53},"Mater Misericordiae University Hospital","OTHER",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100500230","classica-validating-ai-in-classifying-cancer-in-real-time-surgery-100500230","NCT05793554","CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery","Inclusion Criteria:\n\n* Participants with a confirmed or suspected rectal polyp\u002Ftumour measuring greater than 2cm undergoing surgical intervention or assessment OR Patients with a known rectal cancer undergoing surgical intervention or assessment, including those post neo adjuvant therapy.\n* Participant is willing and able to give informed consent for participation in the study. ● Male or Female, aged 18 years or above.\n* Clinically fit for elective intervention\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy within three months of the study\n* Significant renal or hepatic impairment.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. ● Allergy to intravenous contrast agent or iodides\n* Other contraindications to ICG including concurrent use of anticonvulsants, bisulphite containing drugs, methadone and nitrofurantoin.",{"count":62,"type":21},600,"OBSERVATIONAL","Cancer of the lowermost part of the intestine (the rectum) is a common disease and both this disease and its treatment can have major impact on patients. Unless treated early, the disease can progress, spread to other parts of the body and ultimately cause death. Treatment often involves radical surgery, but this too has consequences and risks major complications. Best outcomes regarding cure with least impact depend on the disease being detected at an early stage as rectal cancer tends to start first as a non-cancerous polyp.\n\nThe smallest of these precursor polyps can be easily removed during a routine colonoscopy but once the polyp grows over 2cm in size it is much harder to categorise correctly as the risk of it containing cancer somewhere in it increases markedly. If there is definitely cancer present in such a polyp it is best treated from the outset as a cancer with major surgery, but if there is definitely not a cancer in it then it can be removed from inside the bowel with minimally invasive techniques. Unfortunately, despite our current very best methods, up to 20% of tumours initially thought to be benign are found to be malignant only after they are excised\n\nWe have previously shown that cancerous and non-cancerous tissues can be visually differentiated by analysis of their perfusion during the examination. For this we use a specific approved fluorescent dye, indocyanine green (ICG). ICG is commonly used in bowel surgery anyway to assess the blood supply to the bowel and has a very good safety profile. ICG is injected into the bloodstream during surgery and the rate at which it is taken up by various tissue types is detected by specific and approved cameras which can reveal fluorescence in tissue. We have previously found that the rate of uptake of this dye is different in cancer tissue compared to non-cancer tissue and have used artificial intelligence algorithms to measure this difference. However, we now need to ensure that this method can work also in other patients, in other centres and indeed in other countries to ensure it is indeed a valid and useful way of assessing rectal polyps.\n\nThe goal of this observational study is to validate the use of fluorescence pattern analysis in the classification of rectal tumours. Patients enrolled in the study will attend for a visual examination of the rectal tumour in theatre as is standard practice. During this examination a video recording of the fluorescence perfusion will be taken following ICG administration. Patients will then have the tumour excised or treated as is standard of care by their surgeon. The video will later be analysed to determine the pattern of fluorescence perfusion within the tumour, and a classification will be assigned based on the pattern seen. All tumours that are excised are examined under the microscope by a pathologist to determine the final diagnosis. The fluorescence based classification will be compared to this pathological diagnosis to determine the accuracy of the method. So, patients will still have the exact same standard of care as currently happens, the hope is that in future this method can be developed to the point where it could be useful by means of a useable, accurate automated software process. If so, that will form the basis of another study in the future to look to see if it can guide or even replace biopsies and help with ensuring complete removal ('clear margins') after excision.",[66,67,68],"Rectum Neoplasm","Rectum Polyp","Rectal Cancer",[70,71,72,73],"Fluorescence","Indocyanine green","Tumour classification","Artificial Intelligence","RECRUITING","2025-01-15",{"date":77,"type":46},"2025-01-17",{"date":79,"type":46},"2023-03-31",{"date":81,"type":21},"2027-03",{"name":52,"class":53},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":93,"studyType":63,"phases":4,"briefSummary":94,"conditions":95,"keywords":103,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":83},"100570559","augur-ai---indocyanine-green-fluorescence-angiography-representer-100570559","NCT06708819","AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer","AUGUR-AI","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18 years or above.\n* Colorectal disease requiring segmental resection with anastomosis.\n* Participant has clinically acceptable laboratory results, including liver function tests.\n* In the Investigator's opinion, is able and willing to comply with all study requirements.\n* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Participant who is pregnant, lactating or planning pregnancy during the course of the study.\n* Significant renal or hepatic impairment.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Allergy to intravenous contrast agent or indocyanine green.\n* Concurrent use of anticonvulsants, bisulphite containing drugs, methadone and nitrofurantoin.",{"count":92,"type":21},300,"90 Days","Surgery can effectively treat colorectal cancer, but it is a complex procedure with risks and complications. Surgeons often rely on cameras to visually guide their instruments during operations, especially in minimally invasive (\"keyhole\") and endoscopic procedures. The camera is connected to a computer and generates the internal scene onto a display screen, which the surgeon looks at throughout the procedure, helping them make informed decisions throughout the operation. Fluorescence-guided surgery uses a particular type of camera that can detect images in both normal light and in the near-infrared range. To work, it needs the administration of an agent called indocyanine green to a patient and then the camera can see if the agent is in the tissue of interest to the operation at the time of the surgery. In this way, decisions regarding blood supply (\"perfusion\") can be helped, especially related to safety in joining together portions of tissue after removal of disease. The equipment and agent are approved for use in this way and have very good safety profiles. Many international studies have already demonstrated that the use of fluorescence-guided surgery is associated with lower rates of leaks when disease bowel segments are removed, and the healthy ends are joined back together.\n\nPrevious work we have done has shown that sophisticated computing methods can learn to interpret the fluorescence patterns to a similar standard as a surgeon who is very experienced in fluorescence-guided surgery.\n\nIn this study, we aim to assess whether the computer system we have developed work in real-time, in theatre to provide a reliable interpretation of the fluorescence pattern, that would match how an expert would interpret the same pattern. The system's analysis will not impact on the operation; instead, video images will be recorded, processed and analysed by our computer system. The results of the interpretation will not be shown to the operating surgeon during the procedure to avoid any impact on decision-making.",[96,97,98,99,100,101,102],"Colorectal Surgery","Colorectal Resection","Anastomosis, Surgical","Fluorescence Guided Surgery","Indocyanine Green","Perfusion Imaging","Anastomotic Leaks",[70,100,73,104,105],"Bowel Transection","Anastomotic Leak","2024-11-26",{"date":108,"type":46},"2024-11-27",{"date":110,"type":21},"2025-01",{"date":112,"type":21},"2026-01",{"name":52,"class":53},""]