[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07234968":3,"trial-entities:NCT07234968":134,"trial-summary:NCT07234968":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":42,"primary_purpose":43,"phases":44,"enrollment_info":46,"interventions":49,"primary_outcomes":71,"secondary_outcomes":76,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":101,"locations":104,"central_contacts":126,"overall_officials":129,"references":132,"see_also_links":133},"NCT07234968","iRISID-2025-0635","Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy","Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy","RECRUITING","2028-04-30","2026-02","2026-02-17","2025-12-23","Thomas Jefferson University","OTHER",true,"Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.","Patients who are indicated for RCIC will be recruited for this prospective RCT. Ureteral stents will be placed intraoperatively and removed at follow-up visit per surgeon discretion. Either approach would be considered standard of care for muscle invasive bladder cancer, for which radical cystectomy with urinary diversion is the gold standard of treatment.\n\nPatients will be randomized 1:1 to receive stent or no stent during RCIC (Stent: N=35, No Stent: N=35). Randomization will be stratified by surgical approach (open vs. robotic vs. hybrid). The randomization schedule will be created by the study statistician using the method of random permuted blocks.\n\nStent placement, if applicable, will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon. For this study, subjects will continue to be followed for up to 1-year post-op. Subjects will be enrolled in this study for 12 months.\n\nPost treatment, the patient will have a follow-up visit within 30 days post-operatively, 3 months follow-up visit (+\u002F- 1 week), 6 months follow-up visit (+\u002F- 21 days), and 12 months follow-up visit (+\u002F- 21 days). Patient will be followed for 12 months post treatment or until their death. Additional visits or follow-ups may be indicated for instances of the need for replacement of ureteral stents and catheters or percutaneous nephrostomies. The need for surgical repair for a ureteral leak or stricture may also occur.\n\nThe Principal Investigator hypothesizes that patients with no ureteral stent placement during RCIC will not be associated with a higher risk of post-op complications compared to those with a ureteral stent.",[19,20,21,22,23,24],"Bladder Cancer","Muscle-Invasive Bladder Carcinoma","Urothelial Carcinoma","Pelvic Malignancy","Bladder Transitional Cell Carcinoma","Bladder Neoplasm",[26,27,28,29,30,22,19,31,32,33,34,35,36,37,38,39,40,41],"Bladder","Stent-free Cystectomy","Urinary Tract Infection","Urinary Leak","UTI","Urologic Oncology","Muscle-invasive Bladder Cancer","indocyanine green","fluorescence imaging","ureteral stents","RCIC","cystectomy","colorectal","prostate","gynecologic","ileal conduit urinary diversion","INTERVENTIONAL","TREATMENT",[45],"NA",{"count":47,"type":48},70,"ESTIMATED",[50,59,64],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":56},"PROCEDURE","Ureteral Stent Placement","Placement of ureteral stents (double J or single J) intraoperatively during radical cystectomy with ileal conduit urinary diversion (RCIC). Stent placement will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon.",[55],"Arm 1: Ureteral Stent",[57,58,35],"double J","single J",{"type":51,"name":60,"description":61,"armGroupLabels":62},"No Ureteral Stent","Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.",[63],"Arm 2: No Ureteral Stent",{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DIAGNOSTIC_TEST","Indocyanine Green with Fluorescence Imaging","Indocyanine green (ICG) with fluorescence imaging is an advanced technique used to enhance the visualization of the ureters during complex pelvic surgeries, such as those for bladder cancer. The technology helps surgeons identify the ureters, which are the tubes connecting the kidneys to the bladder, and distinguish them from surrounding tissues.",[55,63],[70],"ICG",[72],{"measure":73,"description":74,"timeFrame":75},"Number of urinary tract infection (UTI)","UTI is defined as clinical symptoms consistent with UTI as well as a positive urine culture showing ≥ 10⁵ CFU\u002FmL of a uropathogen. Subjects who do not complete the 90-day follow-up period but had no evidence of infection at last follow-up will be excluded from the analysis. the Mantel-Haenszel stratified-adjusted estimate of the risk difference for incidence of urinary tract infection (risk in no stent arm - risk in stent arm) will be estimated along with one-sided (upper bound) 80% confidence interval.","90 days after surgery",[77,80],{"measure":78,"description":79,"timeFrame":75},"Incidence of urinary leak","Measurement will be the presence or absence of a urinary leak. Urinary leak will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP\u002FCMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with a urinary leak within the time frame.",{"measure":81,"description":82,"timeFrame":83},"Incidence of ureteral stricture","Measurement will be the presence or absence of ureteral stricture. Ureteral stricture will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP\u002FCMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.","12 months after surgery","ALL","18 Years","85 Years",false,{"inclusion":89,"exclusion":94,"raw_text":100},[90,91,92,93],"Provide signed and dated informed consent form","Willing to comply with all study procedures and be available for the duration of the study","Male or female, age 18 to 85","Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion",[95,96,97,98,99],"An individual who meets any of the following criteria will be excluded from participation in this study:","Current or history of pelvic radiation","Retroperitoneal fibrosis","Untreated urinary tract infection (UTI) within 30 days prior to RCIC","Pregnancy","Inclusion Criteria:\n\n* Individuals must meet all the following inclusion criteria to be eligible to participate in the study:\n\n  * Provide signed and dated informed consent form\n  * Willing to comply with all study procedures and be available for the duration of the study\n  * Male or female, age 18 to 85\n  * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  * Current or history of pelvic radiation\n  * Retroperitoneal fibrosis\n  * Untreated urinary tract infection (UTI) within 30 days prior to RCIC\n  * Pregnancy",[102,103],"ADULT","OLDER_ADULT",[105,119],{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":116},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107","United States",[112],{"name":113,"role":114,"phone":115},"Mihir S Shah, MD","CONTACT","215-955-6961",{"lat":117,"lon":118},39.95238,-75.16362,{"facility":120,"status":121,"city":107,"state":108,"zip":122,"country":110,"contacts":123,"geoPoint":125},"Jefferson Einstein Philadelphia Hospital","NOT_YET_RECRUITING","19141",[124],{"name":113,"role":114,"phone":115},{"lat":117,"lon":118},[127],{"name":113,"role":114,"phone":115,"email":128},"Mihir.Shah@jefferson.edu",[130],{"name":113,"affiliation":13,"role":131},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":135,"biomarkers":140},[136,137,138,22,139],"Bladder Carcinoma","Colorectal Carcinoma","Malignant Female Reproductive System Neoplasm","Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This study is an interventional trial where participants are randomly assigned to one of two groups: receiving a ureteral stent or not receiving one during surgery. Approximately 70 participants will be enrolled.","completed","Study on Ureteral Stent Use During Bladder Cancer Surgery","This study is looking at whether placing a ureteral stent (a small tube that helps urine flow from the kidney to the bladder) during surgery for bladder cancer affects recovery. The surgery is called a radical cystectomy with ileal conduit urinary diversion (RCIC), which removes the bladder and creates a new way for urine to leave the body. You would be randomly assigned to either receive a ureteral stent during your surgery or not. Researchers will then compare the number of urinary tract infections (UTIs) in both groups 90 days after surgery. This study is open to men and women aged 18 to 85 who have been diagnosed with bladder cancer or other pelvic cancers requiring this surgery. The study is currently recruiting about 70 participants, but its exact status is unclear.","Participants will be followed for 12 months after their surgery.",132,"If you join, you will undergo radical cystectomy with ileal conduit urinary diversion (RCIC). You will have follow-up visits within 30 days, 3 months, 6 months, and 12 months after surgery.","Not stated in the trial record.",[],"v2"]