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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA155388 | U.S. NIH Grant/Contract | View source | |
| 36911 | Other Identifier | Investigator-Assigned ID |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open cystectomy | Active Comparator | Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis. |
|
| Robotic assisted radical cystectomy | Active Comparator | Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open radical cystectomy | Procedure | Standard of care removal of urinary bladder. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 2-year Progression Free Survival (PFS) | Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease. | 24 months |
| Number of Participants With Positive Margins | Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue. | At time of cystectomy, approximately 1 hour. |
| Number of Participants Requiring Lymph Node Dissection | Evaluated are the number of participants requiring extended or standard lymph node dissection | At time of cystectomy, approximately 1 hour |
| Quality of Life (QOL) Outcomes | Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL. | at baseline, 3 month, and 6 months |
| Number of Participants With Post-surgical Complications | Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications. | 90 days post operative |
| Amount of Estimated Blood Loss (EBL) in ml | Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | Fixed and variable costs associated with the procedure. | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dipen J Parekh, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| University of California, Irvine Medical Center (UC Irvine) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40080805 | Derived | Venkatramani V, Reis IM, Gonzalgo ML, Swain S, Svatek RS, Parekh DJ. Comparison of Complication and Readmission Rates Between Robot-Assisted and Open Radical Cystectomy: Results From the Randomized RAZOR Clinical Trial. J Urol. 2025 Jun;213(6):684-692. doi: 10.1097/JU.0000000000004497. Epub 2025 Mar 13. | |
| 35171260 | Derived | Venkatramani V, Reis IM, Gonzalgo ML, Castle EP, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Parekh DJ. Comparison of Robot-Assisted and Open Radical Cystectomy in Recovery of Patient-Reported and Performance-Related Measures of Independence: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148329. doi: 10.1001/jamanetworkopen.2021.48329. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Radical Cystectomy | Standard of care treatment |
| FG001 | Robotic Assisted Radical Cystectomy | Standard of care treatment using DaVinci robot |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2014 |
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Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy
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| Robotic assisted radical cystectomy |
| Procedure |
Standard of care removal of urinary bladder using DaVinci robot. |
|
| DaVinci robot | Device | DaVinci robotic surgical system. |
|
| At time of cystectomy, approximately 1 hour |
| Number of Participants Requiring Blood Transfusion | Number of participants requiring peri, intra, and post operative blood transfusion. | At time of cystectomy, approximately 1 hour |
| Number of Days of Post Operative Length of Hospital Stay | Number of days of post operative length of hospital stay will be evaluated | Day 10 post surgery |
| Length of Operative Time | Length of minutes of cystectomy procedure | At time of cystectomy, approximately 1 hour |
| Laboratory Values | Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL) | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months |
| Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence. | baseline, 1 month , 3 months, 6 months |
| Percentage of Participants With 3-year Progression Free Survival (PFS) | Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease. | 3 years |
| Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health. | baseline, 3 month, and 6 month |
| Total Number of Participants Requiring Intra-operative Fluid Requirement | Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion. | At time of cystectomy, approximately 1 hour |
| Total Postoperative Analgesic Requirements | Total postoperative analgesic requirements in milli grams | At time of cystectomy, approximately 1 hour |
| Creatinine Value. | Serum creatinine will be reported in milligrams per deciliters (mg/dL). | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months |
| Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence. | baseline, 1 month, 3 months, 6 months |
| Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer. | baseline, 1 month, 3 months, 6 months |
| Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again. | baseline, 1 month, 3 months, 6 months |
| Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy [FACT-BL-Cys]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing. | baseline, 3 months, 6 months |
| Orange |
| California |
| 92868 |
| United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| The University of Texas Health Science Center at San Antonio, Medical Arts & Research Center | San Antonio | Texas | 78229 | United States |
| University of Virginia Health Science Center, Department of Urology | Charlottesville | Virginia | 22908 | United States |
| Cancer Research and Biostatistics (Data Management and Statistical Office) | Seattle | Washington | 98101 | United States |
| 29976469 | Derived | Parekh DJ, Reis IM, Castle EP, Gonzalgo ML, Woods ME, Svatek RS, Weizer AZ, Konety BR, Tollefson M, Krupski TL, Smith ND, Shabsigh A, Barocas DA, Quek ML, Dash A, Kibel AS, Shemanski L, Pruthi RS, Montgomery JS, Weight CJ, Sharp DS, Chang SS, Cookson MS, Gupta GN, Gorbonos A, Uchio EM, Skinner E, Venkatramani V, Soodana-Prakash N, Kendrick K, Smith JA Jr, Thompson IM. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial. Lancet. 2018 Jun 23;391(10139):2525-2536. doi: 10.1016/S0140-6736(18)30996-6. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Randomization |
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| Surgery |
|
|
Data analysis completed for participants who finished the study as per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Cystectomy | Standard of care treatment, open cystectomy |
| BG001 | Robotic Assisted Radical Cystectomy | Standard of care treatment, robotic assisted radical cystectomy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Data analysis completed for participants who finished the study as per protocol. | Data analysis completed for participants who finished the study as per protocol. | Count of Participants | Participants |
| ||||||||||||||
| Ethnicity (NIH/OMB) | Data analysis were completed only for the participants that completed the study. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Data analysis completed for participants who finished the study as per protocol. | Data analysis completed for participants who finished the study as per protocol. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 2-year Progression Free Survival (PFS) | Progression will be determined by the treating physician using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease. | Posted | Median | 95% Confidence Interval | percentage of participants | 24 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Positive Margins | Evaluated are the number of participants with positive surgical, bladder, and urethral margins. Positive margin is defined as presence of tumor cells at the edge of the dissected tissue. | Posted | Count of Participants | Participants | At time of cystectomy, approximately 1 hour. |
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Requiring Lymph Node Dissection | Evaluated are the number of participants requiring extended or standard lymph node dissection | 1 participant in the RARC group did not have lymph node dissection. | Posted | Count of Participants | Participants | At time of cystectomy, approximately 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | Quality of Life (QOL) Outcomes | Functional Assessment of Cancer Therapy- Vanderbilt Cystectomy Index (FACT-VCI) scores range is 0-168 which is sum of physical, emotional, wellbeing, and FACTS Bl Cys. higher scores=better QOL. | Not all enrolled participants completed the QOL questionnaires. | Posted | Mean | 95% Confidence Interval | score on a scale | at baseline, 3 month, and 6 months |
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Post-surgical Complications | Post surgical complications will be evaluated using the Clavien grading system with scores ranging from 0-5 with the higher number indicating increased post-surgical complications. | 90 day complication using Clavien Grading system | Posted | Count of Participants | Participants | 90 days post operative |
|
| ||||||||||||||||||||||||||||||
| Primary | Amount of Estimated Blood Loss (EBL) in ml | Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml. | EBL data was not available on 3 of the open radical cystectomy and 2 of the RARC participants. | Posted | Mean | 95% Confidence Interval | ml | At time of cystectomy, approximately 1 hour |
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants Requiring Blood Transfusion | Number of participants requiring peri, intra, and post operative blood transfusion. | Not all participants in the study required blood transfusion and not all blood transfusion data was available. | Posted | Count of Participants | Participants | At time of cystectomy, approximately 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Days of Post Operative Length of Hospital Stay | Number of days of post operative length of hospital stay will be evaluated | Not all length of stay data is available for all the study participants. | Posted | Mean | 95% Confidence Interval | days | Day 10 post surgery |
|
| |||||||||||||||||||||||||||||
| Primary | Length of Operative Time | Length of minutes of cystectomy procedure | The length of operative time is not available for all participants. | Posted | Mean | 95% Confidence Interval | minutes | At time of cystectomy, approximately 1 hour |
|
| |||||||||||||||||||||||||||||
| Primary | Laboratory Values | Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL) | Number of participants included was based on the data available at specific time points. | Posted | Mean | Standard Deviation | g/dL | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months |
|
| |||||||||||||||||||||||||||||
| Primary | Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire | Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence. | Number of participants changes depending on their data availability at different time points. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 1 month , 3 months, 6 months |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With 3-year Progression Free Survival (PFS) | Progression will be determined by the treating physician using the RECIST Version 1.1 criteria based on radiographic or pathological evidence of disease progression or death from disease. | Posted | Number | 95% Confidence Interval | Percent of participants | 3 years |
|
| ||||||||||||||||||||||||||||||
| Primary | Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire | The SF-8 consists of two component summary scores; physical (PCS) and mental component summary (MCS). They are scored by weighting each score to a norm-based scoring model. The total scores will be reported as a percentile with higher score indicating better quality of health. | Number of participants changes depending on their data availability at different time points. | Posted | Mean | 95% Confidence Interval | percentile | baseline, 3 month, and 6 month |
|
| |||||||||||||||||||||||||||||
| Primary | Total Number of Participants Requiring Intra-operative Fluid Requirement | Total number of participants requiring Intra-operative fluid requirement. (blood+plasma+platelets) Note: In robotic group 1 participant received both plasma and platelets and 1 other received platelets in addition to blood transfusion. In the open group 5 participants received plasma in addition to blood transfusion. | Number of participants included was based on the data available at specific time point. | Posted | Count of Participants | Participants | At time of cystectomy, approximately 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | Total Postoperative Analgesic Requirements | Total postoperative analgesic requirements in milli grams | Posted | Mean | Standard Deviation | mg | At time of cystectomy, approximately 1 hour |
|
| ||||||||||||||||||||||||||||||
| Primary | Creatinine Value. | Serum creatinine will be reported in milligrams per deciliters (mg/dL). | Number of participants included was based on the data available at specific time points. | Posted | Mean | Standard Deviation | mg/dL | baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months |
|
| |||||||||||||||||||||||||||||
| Primary | Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire | Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence. | Number of participants included was based on the data available at specific time points. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 1 month, 3 months, 6 months |
|
| |||||||||||||||||||||||||||||
| Primary | Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test | The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer. | Number of participants included was based on the data available at specific time points. | Posted | Mean | 95% Confidence Interval | kg | baseline, 1 month, 3 months, 6 months |
|
| |||||||||||||||||||||||||||||
| Primary | Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test | The TUG test is measured in seconds. Patients will be timed as they rise from a standard chair, walk 3 meters, turn, walk back, and sit again. | Number of participants included was based on the data available at specific time points. | Posted | Mean | 95% Confidence Interval | seconds | baseline, 1 month, 3 months, 6 months |
|
| |||||||||||||||||||||||||||||
| Primary | Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire | FACT-VCI consists of eight domains: Five subscale scores (physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing, and FACT for patients with Bladder Cancer following Cystectomy [FACT-BL-Cys]) and three derived scores (trial outcome index), FACT-General form (FACT-G), and FACT-BL-Cys Total.The ranges of scores for each domain are as follows: 0-28 for physical, social, and functional wellbeing; 0-24 for emotional wellbeing; 0-60 for FACT-BL-Cys; 0-116 for FACT-VCI Trial Outcome Index (sum of physical wellbeing, functional wellbeing, and FACT-BL-Cys scores); 0-108 for FACT-G (sum of physical, social, emotional, and functional wellbeing scores); and 0-168 for FACT-BL-Cys Total (sum of physical, social, emotional, and functional wellbeing scores, and FACT-BL-Cys).The higher score indicates increased wellbeing. | Not all participants completed the questionnaire at the different visits. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 3 months, 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Cost | Fixed and variable costs associated with the procedure. | Cost data was specified as a secondary endpoint in the protocol, but data could not be collected from all sites due to proprietary reasons. | Posted | Day 7 |
|
|
24 month
Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Cystectomy | Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis. | 0 | 152 | 0 | 152 | 105 | 152 |
| EG001 | Robotic Assisted Radical Cystectomy | Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach. | 0 | 150 | 0 | 150 | 101 | 150 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| ||
| post operative ileaus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anastomotic bowel leak | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colonic perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Superficial wound infection | Infections and infestations | Systematic Assessment |
| ||
| Deep wound infection | Infections and infestations | Systematic Assessment |
| ||
| Intra-abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Stoma site infection | Infections and infestations | Systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal insufficiency requiring dialysis | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Fistula | Renal and urinary disorders | Systematic Assessment |
| ||
| Ureteral Stricture | Renal and urinary disorders | Systematic Assessment |
| ||
| Intestinal stoma leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Intraoperative gastrointestinal injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ureteric anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound disruption | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Failure to wean from vent within 48 hours of surgery | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Re-intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lymphocele | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
| ||
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac event with cardiopulmonary resuscitation | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Sick sinus syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dipen Parekh, MD | University of Miami | 305 243 6591 | parekhd@miami.med.edu |
| Dec 31, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Physician Decision |
|
| underwent robotic cystectomy |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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