[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570330":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":23,"studyPopulation":23,"armGroups":47,"interventions":57,"overallOfficials":65,"centralContacts":69,"locations":78,"responsibleParty":97,"collaborators":99,"id":103,"slug":23,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":23,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":23,"enrollmentInfo":111,"targetDuration":23,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":81,"whyStopped":23,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Cost-effectiveness of PVI relative to usual care","Cost-effectiveness of PVI irrigation relative to usual care will be assessed as the incremental 30-day total societal costs per percent reduction in IAA rate. The Incremental Cost Effectiveness Ratio (ICER) will be calculated as: (societal costs with PVI irrigation minus societal costs with usual care) divided by (IAA rate with PVI minus IAA rate with usual care). IAA will be defined as an image-confirmed fluid collection deemed to be an IAA by an attending surgeon or radiologist, or an abscess confirmed during percutaneous intervention or reoperation. Societal costs will be defined as patient-reported costs plus medical costs for inpatient and outpatient care within 30 days from randomization. PVI will be deemed cost-effective by either 1) reducing 30-day IAA rate without increasing 30-day total societal costs, 2) reducing 30-day total societal costs without increasing 30-day IAA rate, or 3) reducing both 30-day societal costs and IAA rate.","30 day follow up",[14,18,21,25,28,30,32,35],{"measure":15,"description":16,"timeFrame":17},"Total patient-reported costs","Patient-reported costs will be assessed using a patient survey, which will be verbally administered by research personnel at each time point specified.","30 days, 90 days, 6 months, and 12 months",{"measure":19,"description":20,"timeFrame":17},"Health-related quality of life as assessed by the EQ-5D-5L questionnaire","This is a 6 item questionnaire and the first 5 questions are each scored from 1 (no problem) - 5 (unable to), for a maximum score of 25, with a higher number indicating a worse outcome. The 6th question is scored on a Likert scale from 0 (worst health you can imagine) - 100 (best health you can imagine), with a higher score indicating a worse outcome.",{"measure":22,"description":23,"timeFrame":24},"Index admission total hospital costs",null,"Index admission (variable duration)",{"measure":26,"description":23,"timeFrame":27},"90-day total hospital costs","90 day follow up",{"measure":29,"description":23,"timeFrame":24},"Index admission total length of hospital stay",{"measure":31,"description":23,"timeFrame":27},"90-day total length of hospital stay",{"measure":33,"description":23,"timeFrame":34},"Number of days of work missed by participant","12 months",{"measure":36,"description":37,"timeFrame":38},"Postoperative complications","Complications include IAA, clinically relevant IAA, superficial\u002Fdeep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality","90 days follow up",{"allocation":40,"interventionModel":41,"interventionModelDescription":23,"primaryPurpose":42,"observationalModel":23,"timePerspective":23,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":23,"whoMasked":45},"SINGLE",[46],"PARTICIPANT",[48,53],{"label":49,"type":50,"description":23,"interventionNames":51},"PVI","ACTIVE_COMPARATOR",[52],"Drug: PVI",{"label":54,"type":50,"description":23,"interventionNames":55},"Usual Care",[56],"Drug: Usual Care",[58,62],{"type":59,"name":49,"description":60,"armGroupLabels":61,"otherNames":23},"DRUG","After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL\u002Fkg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out",[49],{"type":59,"name":54,"description":63,"armGroupLabels":64,"otherNames":23},"Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (\\\u003C100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.",[54],[66],{"name":67,"affiliation":5,"role":68},"Dalya Ferguson, MD, MS","PRINCIPAL_INVESTIGATOR",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":23,"email":74},"Dalya M Ferguson, MD, MS","CONTACT","(713) 566-5098","Dalya.M.Ferguson@uth.tmc.edu",{"name":76,"role":72,"phone":73,"phoneExt":23,"email":77},"Debbie Nguyen","Debbie.F.Lew@uth.tmc.edu",[79],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-95.36327,29.76328,{"lat":91,"lon":90},[94,96],{"name":67,"role":72,"phone":95,"phoneExt":23,"email":74},"(713) 500-7640",{"name":76,"role":72,"phone":73,"phoneExt":23,"email":77},{"type":68,"investigatorFullName":71,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Assistant Professor",[100],{"name":101,"class":102},"National Center for Advancing Translational Sciences (NCATS)","NIH","100570330",false,"NCT06705842","APPI-Cost Trial for Perforated Appendicitis","The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis","Eligibility for Enrollment\n\nInclusion Criteria:\n\n* Plan to undergo appendectomy for acute appendicitis\n\nExclusion Criteria:\n\n* Preoperative hemodynamic instability requiring ongoing infusion of vasopressors\n* Allergy to iodine\n* Uncontrolled hyper- or hypothyroidism\n* Renal dysfunction\n* Pregnant or breastfeeding\n* Primary language neither English nor Spanish\n* Lack of functioning telephone or email account\n* Incarcerated or in police custody\n\nEligibility for Randomization\n\nInclusion Criteria:\n\n* Enrolled in study preoperatively\n* Intraoperative diagnosis of perforated appendicitis\n\nExclusion Criteria:\n\n* Non-perforated appendicitis","ALL","18 Years",{"count":112,"type":113},346,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.",[119],"Perforated Appendicitis",[119,121,122,123,124,125],"Povidone Iodine","Cost effectiveness","Intra-abdominal abscess","Appendectomy","Implementation science","2025-12-04",{"date":128,"type":129},"2025-12-11","ACTUAL",{"date":131,"type":129},"2025-04-07",{"date":133,"type":113},"2027-03-31",{"name":5,"class":6},1]