[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561244":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Nottingham University Hospitals NHS Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Care","ACTIVE_COMPARATOR","Standard care (SC) will be defined as a written MRI report by a qualified radiologist followed by EUA and intervention as per surgeon's findings. Interventions will include one or combinations of: lay open of fistula, insertion of seton into the fistula tract and \u002F or drainage of abscess. This arm is to provide outcome data on standard care for this condition as a comparator to the experimental arm.",[13],"Diagnostic Test: Standard Care - Written MRI report",{"label":15,"type":16,"description":17,"interventionNames":18},"vEUA (Virtual Examination Under Anaesthetic) - 3D MRI imaging","EXPERIMENTAL","vEUA-enhanced care will be defined as having a vEUA performed by the radiologist following a MRI using the same unmodified sequence from the standard care (SC) arm (in addition to a written radiology report). The surgeon will then be given unlimited access to the vEUA interactive report via standard PC hardware. The surgeon will then perform the EUA and intervention as per SC but with the additional insight garnered from the vEUA interactive report. We will also monitor the time taken to mark up and produce the vEUA and compare this to the time taken to produce a standard MRI report.\n\nThe care in this group will be the same as standard care but with the addition of 3D reconstruction of the MRI scan and review of this by the patient and surgeon.",[19],"Diagnostic Test: Virtual Examination under Anaeastehtic - 3D reconstruction imaging",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Virtual Examination under Anaeastehtic - 3D reconstruction imaging","3D reconstruction of MRI imaging and review by patient and surgeon prior to surgical intervention.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care - Written MRI report","A standard written MRI report will be provided to the surgeon and patient prior to surgical intervention.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Jonathan Paul Evans, MBChB PhD FRCS","CONTACT","+44115 924 9924","80755","nuhnt.researchsponsor@nhs.net",[39],{"facility":40,"status":41,"city":42,"state":26,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Nottingham University Hospital NHS Trust","RECRUITING","Nottingham","NG7 2UH","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-1.15047,52.9536,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":35,"phoneExt":36,"email":37},"Jonathan P Evans, MBChB PhD FRCS",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100561244","virtual-technology-to-improve-the-management-of-perianal-crohn39s-vamp---prospective-100561244",false,"NCT06587646","VirtuAl Technology to Improve the Management of Perianal Crohn's (VAMP) - PROSPECTIVE","A Feasibility Study to Assess a "Virtual" (vEUA) Technology to Improve the Management of Perianal Crohn's Disease","VAMP-PROSPECT","Inclusion Criteria:\n\n* Ability to give informed consent\n* Active perianal Crohn's disease as defined by clinical assessment with fistula or abscess formation\n* A clinical decision has been taken that surgery is required for perianal disease\n* Ages of 18-75\n\nExclusion Criteria:\n\n* Inability to consent\n* history of Proctectomy,\n* absence of a diagnosis of Crohn's disease,\n* perianal fistulising disease not secondary to Crohn's disease,\n* Rectovaginal fistulas\n* Malignant disease\n* Significant cardiovascular or respiratory disease\n* Neurological or cognitive impairment\n* Significant physical disability\n* Significant hepatic disease or renal failure\n* Subjects currently (or in the last three months) participating in another research project\n* Pregnancy or breastfeeding\n* If MRI is contraindicated (e.g. pacemaker).\n* under 18 years old or over 75 years old","ALL","18 Years","75 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"NA","Crohn's is an inflammatory condition that can affect any part of the gut. Over half a million people in the UK live with Crohn's disease and about a quarter will develop a fistula near their back passage. A fistula is an abnormal connection between two surfaces of the body. These can be hard to treat causing pain and infection. Surgery is required to control infection and in extreme cases this can lead to incontinence or even formation of a stoma, when the bowel is brought to the skin and waste goes into a bag on the tummy wall.\n\nPatients with perianal Crohn's are usually referred to a surgeon by their medical team and subsequently undergo a MRI scan and an examination under anaesthesia (EUA) where abscesses (regions of fluid build-up) will be drained and a seton (plastic sling or suture) inserted through the fistula, or the fistula opened to the skin if this will not affect continence. They are then started on specialist medication by the gastroenterologists (gut doctors).\n\nAbscesses or fistulas can be difficult to identify during EUA, leading to ongoing infection and repeat procedures. This causes additional scarring and delays the medical treatment that can allow fistulas to heal. Multiple or incorrectly performed operations can also damage the muscles that help hold stool in the back passage, leading to incontinence.\n\nWe believe that improving how information is communicated between radiology (who report scans) and surgeons will improve their ability to identify and manage all fistulas and collections at operation. Here is a typical MRI report given to the surgeon by the radiologist:\n\n\\'There is a low intersphincteric fistula with predicted internal opening in the lower half of the anal canal at dentate line level between 5-6 o'clock that passes in the intersphincteric plane to the anal verge between 5-6 o\\'clock.\\'\n\nThis protocol was developed in an era when written communication was really the only way to convey information between specialists. Jargon aside, surgeons face significant difficulty interpreting such written descriptions of a complex 3D structure and using it as a surgical guide. Indeed, a major complaint from surgeons is how difficult it is to get real value from these preoperative MRIs, which cost time and money.\n\nWith advances in digital technology, we believe this system can be vastly improved.\n\nMotilent (a UK SME specialising in technology to improve the management of Crohn\\'s Disease) has developed a sophisticated visualisation tool to provide a 3D model of the fistula and surrounding structures, we call this tool Virtual EUA (vEUA), allowing the surgeon to better understand the anatomy of the problem in conjunction with radiology.\n\nWe are aiming to establish whether vEUA changes the behaviour of colorectal surgeons, increasing confidence in identifying and dealing with fistulas, which will reduce the number of surgical procedures required and improve the quality of care, resulting in a cost saving for the hospital and a much-needed step towards more effective management of perianal Crohn\\'s.\n\nAny patient taking part in the trial will be randomly allocated to have the 3D model utilised in their care or standard care. We will use pre- and post-surgical patient questionnaires, surgical questionnaires and MRI imaging to establish if vEUA is safe and effective in improving the care of patients with perianal Crohn\\'s.",[76],"Perianal Crohns Disease",[78,79,80],"Perianal Crohn's Disease","3D imaging","MRI","2026-01-20",{"date":83,"type":84},"2026-01-21","ACTUAL",{"date":86,"type":84},"2024-07-23",{"date":88,"type":70},"2026-09-07",{"name":5,"class":6},1]