Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Urinary Bladder Neoplasms

Urologic Neoplasms

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Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

This is a prospective, randomized study designed to compare two techniques of radical cystectomy with PLND (open and robotic) for bladder cancer.

Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.

open radical cystectomy

Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.

robotic-assisted radical cystectomy

Vincent Laudone, MD

The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.

Randomized Trial Comparing Robotic and Open Radical Cystectomy

A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm.

Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study.

Memorial Sloan Kettering Cancer Center

Intracorporeal Robot Assisted Radical Cystectomy

Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration

Open Radical Cystectomy

John Kelly

James Catto

This is a prospective multicentre randomised controlled trial comparing the outcomes from Intracorporeal RARC (iRARC) with open radical cystectomy (ORC) in patients with bladder cancer. The study will recruit patients with non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC) who have selected radical cystectomy for the treatment of bladder cancer. The time of interest for measurement of the primary outcomes will be 90 days post-surgery.

Eligible patients will include those receiving neo-adjuvant chemotherapy (typically gemcitabine and cisplatin) and those having either an ileal conduit or a neo-bladder reconstruction.

Patients who have selected radical cystectomy after appropriate counselling and following a specialist multi-disciplinary team (SMDT) recommendation, will be approached and asked to consent for this study.

Consenting participants will be randomised 1:1 to either iRARC or ORC. Patients will be followed for a minimum of 90 days post-surgery.

The study will be conducted in National Health Service (NHS) Trusts designated as Cancer Centres.

Patients will be stratified by

* Type of urinary diversion (Continent diversion or ileal conduit)
* Performance status
* Centre Trial assessments will be conducted at baseline (before surgery), whilst participants are on admission and then 5, 12, 26 weeks,1 year and 18 months post surgery.

Radical cystectomy (RC) represents the gold standard treatment for invasive bladder cancer. Reductions in morbidity and mortality from this operation have occurred in recent years through refined anaesthesia, surgical techniques, and centralization of services in high volume centres. The multimodal concept of enhanced recovery after RC (ERAS), which includes pre, intra and post operative steps, has also helped to reduce the length of stay and complications after RC further.

For most abdominal surgery, it is recognized that minimally invasive surgery is less morbid than open surgery, and produces improvements in post-operative recovery without altering the curative nature of the procedure. However, to date, there is little or conflicting evidence of any benefit from minimally invasive surgery over open surgery for RC. This may reflect the complex nature of this procedure (involving surgery to both the urinary and gastro-intestinal tracts), limitations of the current evidence or that there is no benefit. To date, three prospective trials have compared RARC with open RC (ORC). However, each has been limited by sample size and design, or their application of RARC with extra-corporeal reconstruction or have yet to report.

The investigators believe that there are no studies (reported or planned) that have compared optimal RARC (e.g. with intra-corporeal reconstruction) with optimal ORC (e.g. high volume centre using ERAS). In addition, the investigators believe none have adequately assessed the rehabilitation from RC. As such, the investigators now propose a prospective RCT to randomize eligible patients to either ORC or RARC. The investigators will focus upon measures of functional recovery and the return to normal activities.

Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy

A Phase III Multicentre Randomised Controlled Trial to Compare the Efficacy of Robotically Assisted Radical Cystectomy (RARC) and Intracorporeal Urinary Diversion With Open Radical Cystectomy (ORC) in Patients With Bladder Cancer

To compare the number of days alive and out of hospital within 90 days from surgery.

To assess recovery and complications and the return to normal activities.

University College, London

Open Radical Cystectomy, pelvic lymph node dissection, urinary diversion (neobladder or ileal conduit)

Robot assisted radical cystectomy, pelvic lymph node dissection, intracorporeal urinary diversion (neobladder or ileal conduit)

ORC and orthotopic ileal neobladder is performed as previously described. A separate package PLND is performed as in open as in robotic surgery. RARC is performed replicating open surgical procedure.

The orthotopic ileal neobladder model used is the 'vescica ileale padovana' as previously described. An ileal segment, approximately 42 cm long, is chosen at a minimum distance of 20cm far from ileo-cecal valve. A latero-lateral ileal anastomosis is performed with staplers to restore bowel continuity.

For ileal conduit, a 20cm ileal segment (approximately 20 cm long) at a minimum distance of 20 cm from ileo-cecal valve is isolated and transected with staplers. Bowel continuity is restored as previously described. The ileal loop on its distal edge is extracted through abdomen wall at the previously identified stoma point and fixed to abdomen fascia. The ureters are spatulated and a latero-lateral anastomosis according to Wallace 1 technique is performed.

Open or robotic radical cystectomy

Giuseppe Simone, PhD

This prospective randomized study is designed to provide high level of evidence supporting superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially linked to a reduced invasiveness are considered as secondary endpoints. Investigators hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and to faster return to daily activities. These data will be taken into account in a matched cost analysis between arms. Secondary aims include a between arm matched comparison of perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and nighttime continence).

Despite encouraging data deriving from colorectal surgery, evidences in favor to ERAS protocols following RARC are poor. Moreover, according to a recent survey of surgeons with a specialist interest in RC, the adherence to ERAS protocols is \<20% \[1\].

Retrospective and preliminary data from the robotic consortium have supported oncologic effectiveness of RARC; however in the only prospective randomized trial comparing RARC and ORC urinary diversions were performed extracorporeally, potentially impairing the benefits of minimally invasive surgery \[2\].

Robot assisted radical cystectomy (RARC) has the aim of providing adequate cancer control while minimizing invasiveness of open radical cystectomy (ORC). The primary end-point of this trial is to demonstrate a reduction of perioperative transfusion rate in RARC arm by 50% compared to ORC arm.

ERAS protocols may significantly contribute to shortening length of hospital stay, a key outcome in this clinical setting of patients receiving RC, being the mean length of hospital stay around 14 days in Italy. Investigators' hypothesis is that the reduced invasiveness of RARC might contribute to an increased adoption of ERAS protocols (reduced need for reinsertion of nasogastric tube, shorter time to first flatus, to mobilization, to regular diet and finally shorter duration of hospital stay).

Assessment of oncologic outcomes of RARC, although not the primary endpoint of the present study, is certainly an outcome of interest. The expected duration of enrollment (18 mo) should provide 2-yr oncologic outcomes for about 66% of patients. Two-year recurrence free survival has been reported as a valid surrogate marker of long term oncologic survival after RC.

Specific Aim 1:To demonstrate superiority of RARC versus ORC in terms of 50% reduction of perioperative transfusion rates.

Specific Aim 2:

To evaluate invasiveness of both surgical approaches by assessing the adherence to ERAS protocols in both and the incidence of perioperative and 30-d, 90d, 180d complications, readmission rates (30d, 90d). Cost analysis will assess the potential impact of shorter hospital stay on overall costs of robotic procedures.

Specific Aim 3:

To assess quality of life at 6-mo, 12-mo and 24-mo follow-up evaluation and to perform a matched comparison of oncologic and functional outcomes between two arms.

Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.

Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion. Single Centre Prospective Randomized Trial.

Comparison between open and robotic arms.

50% reduction of perioperative transfusion rates in robotic arm.

Ministero della Salute, Italy

Regina Elena Cancer Institute

MD, PhD, COnsultant Urologist

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Standard of care removal of urinary bladder.

Open radical cystectomy

Standard of care removal of urinary bladder using DaVinci robot.

Robotic assisted radical cystectomy

DaVinci robot

Dipen J Parekh, MD

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).

Non inferiority phase 3 randomized clinical trial comparing robotic to open radical cystectomy

Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

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.

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.

Evaluated are the number of participants requiring extended or standard lymph node dissection

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.

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.

Perioperative measures such as EBL will be evaluated by measuring the amount of participant blood loss in ml.

Number of participants requiring peri, intra, and post operative blood transfusion.

Number of days of post operative length of hospital stay will be evaluated

Length of minutes of cystectomy procedure

Serum Hemoglobin (Hb) and Albumin will be reported in grams per deciliters (g/dL)

Participant reported ADL questionnaire is a 7 item questionnaire with scores ranging from 7-21 with a lower score indicating increased independence.

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.

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.

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.

Total postoperative analgesic requirements in milli grams

Serum creatinine will be reported in milligrams per deciliters (mg/dL).

Participant reported IADL questionnaire is an 8 item questionnaire with scores ranging from 8-32 with a lower score indicating increased independence.

The hand grip strength test is measured in kilograms of pressure using a handheld dynamometer.

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.

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.

Fixed and variable costs associated with the procedure.

National Cancer Institute (NCI)

University of Miami

Chairman of Urology

Adverse events (AE) are defined as complications related to the robotic/open cystectomy and/or study procedures as determined by the principal investigator.

Open Cystectomy

Robotic Assisted Radical Cystectomy

Standard of care treatment, open cystectomy

Standard of care treatment, robotic assisted radical cystectomy

Total

Age, Continuous

Data analysis completed for participants who finished the study as per protocol.

Sex: Female, Male

Data analysis were completed only for the participants that completed the study.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dipen Parekh, MD

Standard of care treatment using the DaVinci robot.

Percentage of Participants With 2-year Progression Free Survival (PFS)

Positive surgical margins

Positive bladder margins

Positive urethral margin

Standard of care treatment, robotic assisted radical cystectomy using the DaVinci robot

Number of Participants With Positive Margins

1 participant in the RARC group did not have lymph node dissection.

Number of Participants Requiring Lymph Node Dissection

Baseline Visit

3 Month Visit

6 Month Visit

Not all enrolled participants completed the QOL questionnaires.

Quality of Life (QOL) Outcomes

Clavien grade 0

Clavien grade I

Clavien grade II

Clavien grade III

Clavien grade IV

Clavien grade V

90 day complication using Clavien Grading system

Number of Participants With Post-surgical Complications

EBL data was not available on 3 of the open radical cystectomy and 2 of the RARC participants.

Amount of Estimated Blood Loss (EBL) in ml

Perioperative transfusion

Intraoperative transfusion

Postoperative transfusion

Standard of care treatment, robotic assisted radical cystectomy using DaVinci robot

Not all participants in the study required blood transfusion and not all blood transfusion data was available.

Number of Participants Requiring Blood Transfusion

Not all length of stay data is available for all the study participants.

Number of Days of Post Operative Length of Hospital Stay

The length of operative time is not available for all participants.

Length of Operative Time

Baseline (Hb)

6-weeks (Hb)

3-months (Hb)

6-months (Hb)

12-months (Hb)

24-months (Hb)

36-months (Hb)

Baseline (Albumin)

6-weeks (Albumin)

3-months (Albumin)

6-months (Albumin)

12-months (Albumin)

24-months (Albumin)

36-months (Albumin)

Number of participants included was based on the data available at specific time points.

Laboratory Values

Baseline

1-month

3-months

6-months

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Open radical cystectomy: Standard of care removal of urinary bladder.

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Robotic assisted radical cystectomy: Standard of care removal of urinary bladder using DaVinci robot.

DaVinci robot: DaVinci robotic surgical system.

Number of participants changes depending on their data availability at different time points.

Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire

Percentage of Participants With 3-year Progression Free Survival (PFS)

Baseline (PCS)

3-months (PCS)

6-months(PCS)

Baseline (MCS)

3-months (MCS)

6-months(MCS)

Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire

Number of participants included was based on the data available at specific time point.

Total Number of Participants Requiring Intra-operative Fluid Requirement

Total Postoperative Analgesic Requirements

6-weeks

12-months

24-months

36-months

Creatinine Value.

Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire

Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test

Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test

Physical Wellbeing baseline

Physical Wellbeing 3 months

Physical Wellbeing 6 months

Social Wellbeing baseline

Social Wellbeing 3 months

Social Wellbeing 6 months

Emotional Wellbeing baseline

Emotional Wellbeing 3 months

Emotional Wellbeing 6 months

Functional Wellbeing baseline

Functional Wellbeing 3 months

Functional Wellbeing 6 months

FACT-BL-Cys Baseline

FACT-BL-Cys 3 months

FACT-BL-Cys 6 months

Trial outcome index Baseline

Trial outcome index 3 months

Trial outcome index 6 months

FACT-G baseline

FACT-G 3 months

FACT-G 6 months

FACT-BL-Cys Total baseline

FACT-BL-Cys Total 3 months

FACT-BL-Cys Total 6 months

Not all participants completed the questionnaire at the different visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Trial Comparing Robotic and Open Radical Cystectomy	NCT01076387	Bladder Cancer	open radical cy... robotic-assiste...	19 Years -	Memorial Sloan Kettering Cancer Center
Randomized Trial Comparing Robotic and Open Radical Cystectomy	NCT01076387	Bladder Cancer	open radical cy... robotic-assiste...	19 Years -	Memorial Sloan Kettering Cancer Center
Trial to Compare Robotically Assisted Radical Cystectomy With Open Radical Cystectomy	NCT03049410	Bladder Cancer	Intracorporeal ... Open Radical Cy...	18 Years -	University College, London
Open Versus Robot Assisted Radical Cystectomy With Totally Intracorporeal Urinary Diversion.	NCT03434132	Bladder Cancer	Open or robotic...	-	Regina Elena Cancer Institute
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial	NCT01157676	Bladder Cancer ...	Open radical cy... Robotic assiste... DaVinci robot	18 Years -	University of Miami
Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center	NCT04838873	Bladder Cancer Laparoscopy	Open radical cy... Laparoscopic-as...	30 Years - 80 Years	Cairo University

Spots Global Cancer Trial Database for open radical cystectomy