[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Surgical Outcomes Research Centre (SOuRCe)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100591152","priority-connect-2-trial-100591152",false,"NCT06976710","PRIORITY-CONNECT 2 Trial","Virtual Multimodal Hub for Patients Undergoing Colorectal Cancer Surgery - PRIORITY-CONNECT 2 Randomised Type I Hybrid Effectiveness-Implementation Trial","PC2","Inclusion Criteria:\n\n* Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent\n* Consulting with a colorectal cancer surgeon at least 1 week prior to scheduled surgery\n\nExclusion Criteria:\n\n* Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease\n* Cognitive impairment such that they are unable to provide informed consent","ALL","18 Years",{"count":20,"type":21},564,"ESTIMATED","INTERVENTIONAL",[24],"NA","Objectives:\n\nThe primary aim of this project is to establish the effectiveness of an individualised stepped, multidisciplinary intervention, including education and peer support group, delivered via a virtual multimodal (p)rehabilitation hub, in reducing postoperative complications within 30-days following colorectal cancer surgery, compared to usual care alone.\n\nThe secondary aims will be to obtain data on the likely difference in key outcomes including:\n\n(i) Quality of life (EORTC QLQ-C30 and QLQ-CR29) (ii) Number of days at home within 30, 90 and 365 days after surgery (DAH-30, 90, 365) (iii) Quality of recovery (QoR-15) (iv) Cost-effectiveness (v) Implementation metrics (RE-AIM)\n\nOur hypothesis is that the PRIORITY-CONNECT 2 intervention will be more effective in reducing postoperative complications and more cost-effective than usual care.\n\nStudy design:\n\nPragmatic Randomised Type I Hybrid Effectiveness-Implementation Trial.\n\nPlanned sample size:\n\nTo achieve the primary aim, 564 participants will provide 90% power to detect a 15% difference in 30-day postoperative complication rates between the intervention and control groups. The sample size calculation accounts for up to 10% loss to follow-up, 5% non-compliance and a two-side alpha of 0.05.\n\nSelection criteria:\n\nA sample of 564 participants undergoing colorectal cancer surgery including open, laparoscopic or robotic-assisted surgery (mostly, anterior resection, sigmoid colectomy, hemicolectomy, total proctocolectomy, subtotal colectomy, total colectomy) at sites throughout Australia will be included. These are common colorectal cancer surgeries performed at the participating centres. All the surgeons involved in this study have clinical appointments in their respective hospitals.\n\nInclusion: Adults aged ≥18 years undergoing elective major surgery for colon or rectal cancer with curative intent; and consulting a colorectal surgeon at least 1 week prior to scheduled surgery.\n\nExclusion: Patients undergoing Pelvic Exenteration (PE), Cytoreductive Surgery (CRS) with or without HIPEC, or concurrent surgery for metastatic disease; or cognitive impairment such that they are unable to provide informed consent.\n\nStudy Procedure:\n\nParticipant's treating team will screen and provide an information sheet about the trial to consecutive patients. Interested patients will be contacted by a study researcher to discuss the trial further, answer any questions, confirm eligibility against the inclusion and exclusion criteria, and consent patients. Consenting patients will undergo baseline assessment and be randomised to a virtual multimodal hub (Intervention group) or usual care alone (Control group). The intervention will include the delivery of usual care and evidence-based exercise, nutritional, psychological and nursing interventions, and \u002F or group-delivered peer support. All interventions will be conducted before and after surgery.\n\nDuration of the Study:\n\nApproximately 60 months.\n\nFunding:\n\nMedical Research Future Fund (MRFF) 2023 Early and Mid-Career Researchers (Application ID: 2031563).\n\nSponsor:\n\nThe University of Sydney.",[27,28],"Colorectal Cancer","Colorectal Neoplasms",[30,27,31,32,33,34,35,36,37,38],"Prehabilitation","Surgery","Surgical Outcomes","Randomised Controlled Trial","Virtual Rehabilitation","Virtual Prehabilitation","Multidisciplinary","Virtual Care","Rehabilitation","RECRUITING","2026-05-18",{"date":42,"type":43},"2026-05-20","ACTUAL",{"date":45,"type":43},"2025-10-15",{"date":47,"type":21},"2028-07-30",{"name":49,"class":50},"Surgical Outcomes Research Centre (SOuRCe)","NETWORK",31,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100638434","phase-2-multimodal-prehabilitation-and-rehabilitation-for-men-undergoing-robot-assisted-radical-prostatectomy-100638434","NCT07576335","Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy","Multimodal Perioperative Optimisation for Patients Undergoing Robot-Assisted Radical Prostatectomy: A Randomised Controlled Trial Targeting Postoperative Erectile Dysfunction (ROBOPREP Trial)","ROBOPREP","Inclusion Criteria:\n\n1. Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (RARP) with curative intent for confirmed prostate cancer.\n2. Consulting a urological surgeon with an appointment at participating sites at least 4 weeks prior to scheduled surgery.\n3. Willingness to engage in prescribed self-directed interventions.\n\nExclusion Criteria:\n\n1. Cognitive impairment such that they lack capacity to provide informed consent.\n2. Currently taking intracavernosal injection therapy.\n3. Severe or complete erectile dysfunction at baseline, defined as an IIEF-5 score ≤7 or self-reported absence of erectile function.\n4. Prescribed nitrates or guanylate cyclase stimulators (e.g., riociguat) - pharmacological contraindication to PDE5 inhibitor use.\n5. Impaired renal function (GFR \\\u003C50 mL\u002Fmin and\u002For creatinine clearance \\\u003C30 mL\u002Fmin).\n6. Severe hepatic impairment or concurrent prescription of medications that inhibit CYP3A4.\n7. Loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION).\n8. Myocardial infarction within the last 90 days.\n9. Stroke within the last 6 months.\n10. Unstable angina or angina occurring during sexual intercourse.\n11. New York Heart Association (NYHA) Class II or greater heart failure in the last 6 months.\n12. Uncontrolled arrhythmias, hypotension (\\\u003C90\u002F50 mmHg), or uncontrolled hypertension.\n13. Contraindications to participating in the prescribed exercise program.\n14. No access to a device with internet connectivity.","MALE",{"count":62,"type":21},64,[64],"PHASE2","Prostate cancer is the most common cancer in Australian men. Robot-assisted radical prostatectomy (RARP) - surgical removal of the prostate - is a standard treatment, but it frequently causes erectile dysfunction (ED) and urinary incontinence that can persist for years and significantly affect quality of life.\n\nThis trial (ROBOPREP) will test whether a multimodal program of prehabilitation (before surgery) and rehabilitation (after surgery) improves erectile function and urinary continence in men undergoing RARP, compared to standard care alone.\n\nThe program includes four components, all delivered virtually and in a self-directed manner:\n\n1. Pharmacological - tadalafil 5 mg once daily (a low-dose, TGA-approved erectile medication) beginning 4 weeks before surgery, paused during hospital admission, and resumed for 3 months following catheter removal after surgery.\n2. Exercise - pelvic floor muscle training (3 sets per day) and aerobic exercise (40 minutes, 4 times per week) to strengthen the muscles and vascular supply involved in erectile and urinary function.\n3. Nutrition - dietary guidance to support surgical recovery and vascular health.\n4. Psychological\u002Fwellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety.\n\nA total of 64 men will be recruited across three major Sydney hospitals (Royal Prince Alfred Hospital, Concord Repatriation General Hospital, and Chris O'Brien Lifehouse) and randomly assigned 1:1 to the multimodal program plus standard care, or to standard care alone. Outcomes - including erectile function (primary), urinary continence, quality of life, and psychological wellbeing - are assessed at baseline and at 6 weeks, 3, 6, and 12 months following surgery. All participant-facing elements of the program are digital, low-cost, and designed for real-world scalability.",[67,68,69],"Erectile Dysfunction Following Radical Prostatectomy","Prostate Cancer","Urinary Incontinence Following Surgical Procedure",[71,72,73,74,75,76,77,78,79,80,81,82],"robot-assisted radical prostatectomy","prehabilitation","rehabilitation","erectile dysfunction","urinary incontinence","PDE5 inhibitor","tadalafil","pelvic floor muscle training","prostate cancer","sexual rehabilitation","perioperative care","multimodal intervention","NOT_YET_RECRUITING","2026-05-04",{"date":86,"type":43},"2026-05-08",{"date":88,"type":21},"2026-05-01",{"date":90,"type":21},"2028-11-01",{"name":49,"class":50},3,""]