Urinary Bladder Neoplasms Clinical Trial
Official title:
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
Verified date | January 2021 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 20, 2021 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Urology, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants blinded at discharge | Number of patients that was not unblinded at discharge | 12 months | |
Secondary | Length of Stay (LOS) | Duration (days) of primary hospitalization. From the date of admission until the date of discharge from hospital. | 12 months | |
Secondary | Days Alive and Out of Hospital (DAOH) | Number of days alive and out of hospital within 90 days from surgery | 90 days from surgery | |
Secondary | 30-day complication rate | Complication rate (Clavien-Dindo) | 30 days after surgery | |
Secondary | 90-day complication rate | Complication rate (Clavien-Dindo) | 90 days after surgery | |
Secondary | Readmission rate | Number of readmissions | 90 days after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Blood loss | Both estimated as well as calculated/hidden blood loss | 4 days after surgery | |
Secondary | Use of opioids | Use of opioids, mg total postoperatively | until diacharge or up to 90 days, whichever comes first |
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