[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":70,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Azienda Ospedaliera di Padova","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Laparoscopic debulking surgery - LDS","EXPERIMENTAL","Primary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS)",[13],"Procedure: Laparoscopic Debulking Surgery in advanced ovarian cancer",{"label":15,"type":16,"description":17,"interventionNames":18},"Debulking surgery - DS","ACTIVE_COMPARATOR","Primary debulking surgery or Interval debulking surgery performed by\u002Fconverted to laparotomy (PDS and IDS)",[19],"Procedure: Standard laparotomic Debulking Surgery in advanced ovarian cancer",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Laparoscopic Debulking Surgery in advanced ovarian cancer","Laparoscopic debulking will be conducted until the surgical target is achieved or the operation is converted to laparotomy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard laparotomic Debulking Surgery in advanced ovarian cancer","Debulking by laparotomy in patients when debulking could not be accomplished by laparoscopy.",[15],[32],{"name":33,"affiliation":34,"role":35},"Roberto Tozzi, Professor","Azienda Ospedale Università di Padova","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Matteo Marchetti, Doctor","CONTACT","0039-049-8213445","matteomarchetti91@gmail.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Marco Noventa, Doctor","marco.noventa@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Azienda Ospedaliera Universitaria di Padova,","RECRUITING","Padova","Padova, Veneto","35128","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],11.14261,44.38225,{"lat":58,"lon":57},[61,63,65,68,69],{"name":62,"role":39,"phone":26,"phoneExt":26,"email":41},"Matteo Marchetti, MD",{"name":64,"role":39,"phone":26,"phoneExt":26,"email":44},"Marco Noventa, MD",{"name":66,"role":67,"phone":26,"phoneExt":26,"email":26},"Carlo Saccardi, Professor","SUB_INVESTIGATOR",{"name":64,"role":67,"phone":26,"phoneExt":26,"email":26},{"name":62,"role":67,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Roberto Tozzi","Professor and Chair",[74],{"name":75,"class":6},"University of Padova","100505542","ultra-lap-trial-laparoscopic-debulking-surgery-lds-in-advanced-ovarian-cancer-100505542",false,"NCT05862740","ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer","ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study","ULTRA-LAP","Inclusion Criteria:\n\n* Patients with advanced epithelial ovarian cancer (II-IV Stage FIGO) candidates to PDS (primary debulking surgery) or IDS (interval debulking surgery: neoadjuvant chemotherapy followed by IDS).\n* Participant is willing and able to give informed consent for participation in the study.\n* Female aged 18 years or above.\n* Primary diagnosis of advanced epithelial ovarian cancer (tubal and peritoneal cancer included).\n\nExclusion Criteria:\n\n* Comorbidities non-allowing for radical surgery\n* Poor Performance Status (Karnofsky Index \\\u003C 70)\n* Concomitant or past history of malignancy, regardless of treatment status\n* Recent or past story of pancreatitis or hepatitis\n* Recent or past story of pleural effusion or lung injuries or respiratory failure\n* Cardiac major pathologies","FEMALE","18 Years",{"count":87,"type":88},62,"ESTIMATED","INTERVENTIONAL",[91],"NA","ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer.\n\nThe outcomes to measure are:\n\n* Safety: the rate of patients experiencing intra- and post-operative early and late morbidities (within the hospitalization and up to 60 days from surgery)\n* Efficacy: the rate of patients in which the surgical target set pre-operatively (complete resection) is achieved by laparoscopy.\n* Feasibility: the rate of patients who have their procedure completed by laparoscopy\n\nPatients will undergo laparoscopic debulking surgery (LDS) if the surgical target can be met. If it cannot be achieved by laparoscopy the surgeon will convert to laparotomy.",[94],"Ovarian Cancer",[96,97,98,99,100],"Ovarian cancer","Advanced ovarian cancer","Debulking surgery","Multivisceral surgery","Laparoscopic debulking surgery","2023-05-08",{"date":103,"type":104},"2023-05-17","ACTUAL",{"date":106,"type":104},"2022-01-02",{"date":108,"type":88},"2027-12-31",{"name":5,"class":6},1]