Study Comparing Open Radical Cystectomy With Robot-assisted Cystectomy in Patients With Bladder Cancer

A Controlled Blinded Randomized Feasibility Study of Open Radical Cystectomy (ORC) Versus Robot-Assisted Radical Cystectomy With Intracorporal Urinary Diversion (iRARC) Under an Enhanced Recovery After Surgery (ERAS) Setup

The purpose of the study to compare two established methods of radical cystectomy (RC) in patients with bladder cancer. The participants will be treated under conditions in alignment with up-to-date guidelines and care. We wish to investigate whether it is feasible to compare the two methods under conditions of the highest methodological quality.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Procedure: Radical Cystectomy

Detailed Description

Radical cystectomy (RC) is a comprehensive surgery including pelvic lymph node dissection and urinary diversion. The surgery is originally performed as an open procedure (ORC) but with advances in technology the procedure is now also offered as a robot-assisted laparoscopic procedure (RARC). It remains questionable if RARC is superior to ORC in terms of surgical outcomes.

Several studies have described outcomes following RARC of which most are comparative studies with only five studies being randomized controlled trials (RCTs). Overall, significant differences in operating room time, estimated blood loss, time to flatus and bowel movement as well as use of morphine sulfate equivalents in favor of RARC has been demonstrated with the exception of operating room time. However, no studies have demonstrated a significant reduction in risk of 30- or 90-day complication rates between ORC and RARC. The RCTs have not been blinded, and therefore may be subject to bias in terms of expectations from patients and care providers. Also, in the already conducted RCTs of ORC versus RARC the urinary diversion has been done extracorporally. Today, it is possible to conduct the whole procedure of RARC intracorporally (iRARC), potentially reducing the surgical stress further. Lastly, the previously conducted RCTs have not consequently been managed under an Enhanced Recovery After Surgery (ERAS) setup. Currently, a multicenter study comparing ORC with RARC is recruiting in the United Kingdom in which the patients are treated with iRARC and under an ERAS setup. The present study will compare the two methods blinded for the participants and all health care providers involved in the postoperative care from the time the patient exits the operating room (OR). Blinded studies in surgery are rare but in gastrointestinal surgery, a blinded study of open versus laparoscopic colonic resection has demonstrated to be feasible and thus we believe that such study must be feasible in an RC setting.

Participants will be randomized 1:1 to either ORC or RARC. Blinding: The study is blinded for the patient and for the group of nurses and doctors that will be responsible for the postoperative care. The postoperative care will be managed by members of the bladder cancer team other than the operating surgeon, and OR staff will not be involved in the postoperative care. The abdominal wound will be bandaged to hide the wounds from both an open and laparoscopic procedure. The blinding will be maintained until discharge from hospital.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Department of Urology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age> 18
• non-metastatic disease
• fit for both ORC and RARC
• Patient-selected urinary diversion: ileal conduit

Exclusion Criteria:

• if not able to speak/understand Danish
• not able to cooperate for fully informed consent
• need for extensive concomitant surgery (i.e. nephroureterectomy)
• prior down staging chemotherapy (prior neoadjuvant chemotherapy accepted)
• prior radiation therapy
• prior major extensive abdominal or pelvic surgery
• prior peritonitis
• conditions contraindicating extended Trendelenburg's position

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open Radical Cystectomy (ORC); Open radical cystectomy includes in both genders removal of the bladder and distal ureters as well as pelvic lymphadenectomy. In men the procedure includes removal of the prostate and seminal vesicles and in women removal of the uterus, ovaries, urethra and part of the vagina. Lastly, for both genders an iliac conduit urinary diversion is performed.	Procedure: Radical Cystectomy; Participants are randomly and blinded assigned
Active Comparator: Robot-assisted Radical Cystectomy (iRARC); Robot-assisted radical cystectomy includes in both genders removal of the bladder and distal ureters as well as pelvic lymphadenectomy. In men the procedure includes removal of the prostate and seminal vesicles and in women removal of the uterus, ovaries, urethra and part of the vagina. Lastly, for both genders an intracorporeal iliac conduit urinary diversion is performed.	Procedure: Radical Cystectomy; Participants are randomly and blinded assigned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants blinded at discharge	Number of patients that was not unblinded at discharge	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (LOS)	Duration (days) of primary hospitalization. From the date of admission until the date of discharge from hospital.	12 months
Days Alive and Out of Hospital (DAOH)	Number of days alive and out of hospital within 90 days from surgery	90 days from surgery
30-day complication rate	Complication rate (Clavien-Dindo)	30 days after surgery
90-day complication rate	Complication rate (Clavien-Dindo)	90 days after surgery
Readmission rate	Number of readmissions	90 days after surgery
Quality of Life (QoL): EORTC QLQ-C30	Registration of differences in QoL. European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ-C30 (scale range 0-100, a higher score indicating better quality of life))	90 days after surgery
Quality of Life (QoL): EORTC QLQ-BLM30	Registration of differences in QoL. European Organization for Research and Treatment of Cancer quality of life questionnaire for patients with muscle invasive bladder cancer (QLQ-BLM30 (scale range 0-100, a higher score indicating increase in symptom burden)) will be used.	90 days after surgery
Blood loss	Both estimated as well as calculated/hidden blood loss	4 days after surgery
Use of opioids	Use of opioids, mg total postoperatively	until diacharge or up to 90 days, whichever comes first

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Bladder Cancer; Radical cystectomy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: H-18056682-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No