An interventional study of Radical Cystectomy in Urinary Bladder Neoplasms, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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
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
Participants blinded at discharge
Number of patients that was not unblinded at discharge
Time frame: 12 months
Length of Stay (LOS)
Duration (days) of primary hospitalization. From the date of admission until the date of discharge from hospital.
Time frame: 12 months
Days Alive and Out of Hospital (DAOH)
Number of days alive and out of hospital within 90 days from surgery
Time frame: 90 days from surgery
30-day complication rate
Complication rate (Clavien-Dindo)
Time frame: 30 days after surgery
90-day complication rate
Complication rate (Clavien-Dindo)
Time frame: 90 days after surgery
Readmission rate
Number of readmissions
Time frame: 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))
Time frame: 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.
Time frame: 90 days after surgery
Blood loss
Both estimated as well as calculated/hidden blood loss
Time frame: 4 days after surgery
Use of opioids
Use of opioids, mg total postoperatively
Time frame: until diacharge or up to 90 days, whichever comes first
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark