[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552117":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":59,"id":62,"slug":33,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":33,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":42,"whyStopped":33,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Casa di Cura Dott. Pederzoli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drain removal on POD 1","ACTIVE_COMPARATOR","in case of POD 1 DFA\\\u003C 300 U\u002FL",[13],"Behavioral: 1st day removal of abdominal drain",{"label":15,"type":10,"description":11,"interventionNames":16},"Drain removal on POD 3",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL","1st day removal of abdominal drain","once POPF is excluded in middle-low risk pancreatic resection, abdominal drains can be removed",[9,15],[24],"3rd day removal of abdominal drains",[26],{"name":27,"affiliation":5,"role":28},"isabella frigerio, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":27,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","00390456449187",null,"isabella.frigerio@ospedalepederzoli.it",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"giovanni butturini, MD","00390456449283","butturinichirurgo@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Cdcpederzoli","RECRUITING","Peschiera del Garda","Verona","37019","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],10.68614,45.43912,{"lat":52,"lon":51},[55],{"name":27,"role":31,"phone":32,"phoneExt":33,"email":34},{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Isabella Frigerio","MD PhD",[60],{"name":61,"class":6},"University of Padova","100552117",false,"NCT06468917","First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial","First-day Versus Early Drain Removal Following Pancreaticoduodenectomy: a Randomized Controlled Trial","FIDEL","Inclusion Criteria:\n\n* Patients (age ≥ 18 or \\\u003C 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.\n* Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)\n* POD 1 DFA \\\u003C 300U\u002FL\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>85\n* Patients with high risk of developing pancreatic fistula (ISGPS class D)\n* Intraoperative positioning of external or internal pancreatic stent\n* POD 1 DFA ≥300\n* Sinister appearance of drain effluent (defined as dark brown to clear \"spring water\" fluid that looks like pancreatic juice contaminated) as mentioned in literature3-22\n* Early post-pancreatectomy hemorrhage\n* Intraoperative conditions different from POPF risk, requiring prolonged intrabdominal drains\n* Previous bilio\u002Fpancreatic surgery\n* Allergy to drain materials\n* Significant coagulation disorders\n* Patients unable to provide informed consent.\n* Clinical suspect of another surgery-related fistula different than POPF","ALL","18 Years","85 Years",{"count":73,"type":74},224,"ESTIMATED","INTERVENTIONAL",[77],"NA","Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded.\n\nAIM we aim to compare postoperative surgical outcomes after PD in patients with low\u002Fmedium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal.\n\nPrimary aim: 1) grade B\u002FC POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\\>3, 90 days mortality, re-admission.\n\nStudy Design:\n\nThis is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes.\n\nGroup A: Drain removal on POD 1 (in case of POD 1 DFA\\\u003C 300 U\u002FL) Group B: Drain removal on POD 3 (in case of POD 1 DFA\\\u003C 300 U\u002FL)",[80],"Pancreas Fistula Abdominal Drains",[82],"pancreatic fistula pancreaticoduodenectomy drain fluid amylase","2024-06-20",{"date":85,"type":86},"2024-06-21","ACTUAL",{"date":88,"type":86},"2024-06-01",{"date":90,"type":74},"2026-03-30",{"name":5,"class":6},1]