[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100375466":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery","EXPERIMENTAL","Patients who choose operations will have surgery performed to remove the appendix laparoscopically, through 3 or 4 small incisions. All patients in the operative group will receive standard perioperative antibiotics. They will also have the abscess(es) drained during the same surgery if there is one present. In some cases, the operation may be too difficult to perform laparoscopically, so an open appendectomy will be performed, involving a longer incision to remove the appendix. In some cases, both laparoscopic and open are performed. The surgeon may also choose to remove a section of the intestine with the appendix or perform additional procedures.",[13],"Procedure: Operative management",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-operative management","ACTIVE_COMPARATOR","If a patient chooses non-operative management and if an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.",[19],"Other: Drainage or antibiotics",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Operative management","Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Drainage or antibiotics","If an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Kevin Schuster, MD, MPH","CONTACT","203 785 2572","kevin.schuster@yale.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Yale New Haven Hospital","RECRUITING","New Haven","Connecticut","06512","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-72.92816,41.30815,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":36},"Kevin Schuster, MD","+1 (203) 785-2572",{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100375466","operative-versus-non-operative-management-for-appendicitis-with-abscess-or-phlegmon-100375466",false,"NCT04168866","Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon","Inclusion Criteria:\n\n1\\. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).\n\nExclusion Criteria:\n\n1. Antibiotic therapy greater than 24 hours prior to considering for enrollment.\n2. Attempted drainage before randomization\n3. Pregnancy\n4. Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.\n5. Previous major intra-abdominal surgery by laparotomy\n6. Hospitalization within 2 weeks of randomization\n7. Presence of septic shock on admission.\n8. Mechanical ventilation\n9. Acute renal failure requiring dialysis","ALL","18 Years",{"count":67,"type":68},180,"ESTIMATED","INTERVENTIONAL",[71],"NA","The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.",[74],"Appendicitis","2025-08-22",{"date":77,"type":78},"2025-08-29","ACTUAL",{"date":80,"type":78},"2020-03-11",{"date":82,"type":68},"2029-12-31",{"name":5,"class":6},1]