NCT03977831

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

May 29, 2019

Last Update Submit

January 22, 2021

Conditions

Urinary Bladder Neoplasms

Keywords

Bladder CancerRadical cystectomy

Outcome Measures

Primary Outcomes (1)

  • Participants blinded at discharge

    Number of patients that was not unblinded at discharge

    12 months

Secondary Outcomes (9)

  • Length of Stay (LOS)

    12 months

  • Days Alive and Out of Hospital (DAOH)

    90 days from surgery

  • 30-day complication rate

    30 days after surgery

  • 90-day complication rate

    90 days after surgery

  • Readmission rate

    90 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

Open Radical Cystectomy (ORC)

ACTIVE COMPARATOR

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 (iRARC)

ACTIVE COMPARATOR

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

Interventions

Radical CystectomyPROCEDURE

Participants are randomly and blinded assigned

Open Radical Cystectomy (ORC)Robot-assisted Radical Cystectomy (iRARC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

  • Maibom SL, Joensen UN, Aasvang EK, Rohrsted M, Thind PO, Bagi P, Kistorp T, Poulsen AM, Salling LN, Kehlet H, Brasso K, Roder MA. Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study. Pilot Feasibility Stud. 2023 Jan 13;9(1):7. doi: 10.1186/s40814-022-01229-3.

    PMID: 36639814DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 6, 2019

Study Start

June 6, 2019

Primary Completion

November 1, 2020

Study Completion

January 20, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)