[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545816":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":60,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Collagen Paste","EXPERIMENTAL","Seton is removed, the fistula tract is de-epithelialised and collagen paste applied.",[13],"Procedure: Collagen Paste",{"label":15,"type":16,"description":17,"interventionNames":18},"Mucosal Advancement Flap","ACTIVE_COMPARATOR","The internal opening is excised and is covered with a \"U-shape\" rectal mucosal flap",[19],"Procedure: Mucosal advancement",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Collagen paste injection",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Mucosal advancement","Mucosal advancement flap",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Kaori Futaba, FRCS","CONTACT","35051495","kfutaba@surgery.cuhk.edu.hk",[37,53],{"facility":38,"status":39,"city":40,"state":41,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Surgery, Chinese University of Hong Kong","RECRUITING","Shatin","New Territories","Hong Kong","HK",{"type":45,"coordinates":46},"Point",[47,48],114.18333,22.38333,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":25,"phoneExt":25,"email":35},"Kaori Futaba",{"facility":54,"status":39,"city":40,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Prince of Wlaes Hospital",{"type":45,"coordinates":56},[47,48],{"lat":48,"lon":47},[59],{"name":52,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":61,"investigatorFullName":52,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Associate Professor","100545816","collagen-paste-vs-mucosal-advancement-flap-for-fia-100545816",false,"NCT06386835","Collagen Paste vs Mucosal Advancement Flap for FIA","Collagen Paste Injection Compared With Mucosal Advancement Flap for the Treatment of Fistula-in-ano: Single Centre Non-inferiority Randomised Controlled Trial","Inclusion Criteria:\n\n* Clinical diagnosis of high cryptoglandular fistula-in-ano.\n* Patients must have undergone a prior EUA to characterise the nature of the fistula.\n* The fistula tract should be ≥ 2 cm in length.\n* Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.\n* Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.\n* Patients must be aged ≥ 18 years and able to provide informed consent.\n* Fistulas must be of cryptoglandular aetiology.\n\nExclusion Criteria:\n\n* Unable\u002Funwilling to provide informed consent.\n* Contraindication to general anaesthesia or spinal anaesthesia.\n* Low trans-sphincteric fistulas.\n* Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).\n* Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).\n* Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.\n* Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis\u002Fcollection, the clinical opinion will prevail.\n* Cultural or religious objection to the use of pig tissue.\n* Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).\n* Patients with recurrent anal fistulas previously treated with a fistula plug.","ALL","18 Years",{"count":73,"type":74},118,"ESTIMATED","INTERVENTIONAL",[77],"NA","The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.",[80],"Fistula-in-ano","2024-04-24",{"date":83,"type":84},"2024-04-26","ACTUAL",{"date":86,"type":84},"2024-01-26",{"date":88,"type":74},"2027-03-31",{"name":5,"class":6},2]