[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497040":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is set to the following settings: 10,5 Volt, 14 hz, 330 Micro sec, Cycling 5 seconds off 0,1 sec on. The pacemaker is turned on.",[13],"Device: Gastric electrical stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","A pace lead is mounted on the stomach, and exteriorized trough the skin and connected to an external pacemaker. The pacemaker is turned off.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Gastric electrical stimulation","Mounting of a temporary gastric pacemaker",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Jonas Funder, MD, PhD","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Anne K Martensen, MD","CONTACT","+45 30595095","anmate@rm.dk",[38],{"facility":29,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Aarhus","8200","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],10.21076,56.15674,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":25,"phoneExt":25,"email":25},"Anne Martensen, MD",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[56],{"name":57,"class":6},"Danish Cancer Society","100497040","gastrointestinal-stimulation-as-a-treatment-of-postoperative-ileus-following-extensive-surgery-100497040",false,"NCT05752071","Gastrointestinal Stimulation As a Treatment of Postoperative Ileus Following Extensive Surgery","GaStrointestinal STIMULation As a Treatment of Postoperative IlEus Following Extensive Surgery (STIMULATE). -A Prospective Double-blinded Randomized Controlled Trial","STIMULATE","Inclusion Criteria:\n\n* Patients planned for elective cytoreductive surgery with or without heated intraperitoneal chemotherapy due to either colorectal or appendiceal cancer or with peritoneal metastases or due to pseudomyxoma peritonei\n* Written and orally informed consent\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Previous upper gastric or esophageal resection\n* History of difficulties in swallowing or gastrointestinal stenosis\n* Implanted or portable electrical medical device e.g. cardiac pacemaker, defibrillator or infusion pump etc.\n* Pregnant or breast-feeding women","ALL","18 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to investigate the effect of gastrointestinal stimulation with a pacemaker on the length of postoperative bowel paralysis in patients undergoing major abdominal surgery due to metastasizing colorectal cancer, appendiceal cancer or pseudomyxoma peritonei.\n\nThe main question it aims to answer is if the length of postoperative ileus is reduced when the gastrointestinal tract is stimulated with a pacemaker.\n\nAll participants will undergo cytoreductive surgery +\u002F- heated intraperitoneal chemotherapy (the standard treatment for colorectal cancer, appendiceal cancer with peritoneal carcinomatosis or pseudomyxoma peritonei). After surgery, but before the abdomen is closed a pace lead will be attached to the stomach, exteriorized trough the abdominal wall and connected to an external pacemaker. The pacemaker is either turned on (experimental group) or off (control group).\n\nAfter surgery, patients will be asked to fill out a diary on bowel movements once a day. Once normal bowel function is regained, the pace lead and pacemaker will be removed trough the abdominal wall with a firm pull.",[76,77],"Postoperative Ileus","Bowel Paralysis",[79,80],"Stimulation","Postoperative ileus","2025-01-28",{"date":83,"type":84},"2025-01-31","ACTUAL",{"date":86,"type":84},"2023-04-01",{"date":88,"type":70},"2027-09",{"name":5,"class":6},1]