Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000614796
Ethics application status
Approved
Date submitted
8/04/2022
Date registered
26/04/2022
Date last updated
1/06/2024
Date data sharing statement initially provided
26/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Study assessing reconstruction of the urinary tract via robotic (intracorporeal) or open (extracorporeal) method during removal of the bladder.
Scientific title
UDIVERT: Randomised study assessing the effect of intracorporeal versus extracorporeal urinary diversion on hospital length of stay in patients undergoing robotic assisted cystectomy
Secondary ID [1] 306875 0
NIL
Universal Trial Number (UTN)
Trial acronym
UDIVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radical Cystectomy 325974 0
Condition category
Condition code
Cancer 323289 323289 0 0
Bladder
Surgery 323367 323367 0 0
Other surgery
Renal and Urogenital 323368 323368 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in the UDIVERT randomised trial is intra-corporeal urinary diversion during a Robot-Assisted Radical Cystectomy surgical procedure. Intra-corporeal urinary diversion (ICUD) involves performing diversion using the Da Vinci Xi Surgical Robot's arms internally, within the body. Urinary diversion involves a 15cm segment of small bowel (ileum) which is resected but kept on the mesentery to maintain its blood supply. The cut ends of the ileum are joined back together to reform continuity of the small bowel. Each ureter is joined to the segment of ileum over a stent (uretero-ileal anastomosis) which remains inside the body. The distal end of the ileal segment is brought out through the abdominal wall as a spouted stoma using sutures to adhere the bowel to the skin outside the body. For ICUD, a laparoscopic stapler device is used to perform the preparation of the segment of ileum. The only incisions required for this arm of the trial are for four robotic ports (8mm), placed under vision and a further two assistant ports (12 and 15mm) are inserted. It is expected this procedure will take around 6 hours to perform in entirety. All surgeons performing the interventions are experienced robotic and urological surgeons. All operations are audited as part of the Trial. This is to collect pertinent data, but also to ensure compliance to arm of intervention.
Intervention code [1] 323332 0
Treatment: Surgery
Comparator / control treatment
The control treatment in the UDIVERT randomised trial is extra-corporeal urinary diversion during a Robot-Assisted Radical Cystectomy surgical procedure. Extra-corporeal urinary diversion (ECUD) involves performing diversion using a standard open ileal conduit. Urinary diversion involves a 15cm segment of small bowel (ileum) which is resected but kept on the mesentery to maintain its blood supply. The cut ends of the ileum are joined back together to reform continuity of the small bowel. Each ureter is joined to the segment of ileum over a stent (uretero-ileal anastomosis) which remains inside the body. The distal end of the ileal segment is brought out through the abdominal wall as a spouted stoma using sutures to adhere the bowel to the skin outside the body. For ECUD, a 10–15-cm incision is used to perform the diversion extracorporeally. This is in addition to the small incisions resulting from the robot assisted cystectomy part of the procedure performed prior to urinary diversion. It is expected this procedure will take around 5 hours to perform in entirety. All surgeons performing the interventions are experienced robotic and urological surgeons. All operations are audited as part of the Trial. This is to collect pertinent data, but also to ensure compliance to arm of control.
Control group
Active

Outcomes
Primary outcome [1] 331021 0
Hospital length of stay assessed by accessing patient electronic medical records.
Timepoint [1] 331021 0
Time the patient leaves the operating room until time of discharge
Secondary outcome [1] 408752 0
Complications according to Clavien-Dindo system.
Timepoint [1] 408752 0
30 and 90 days post-operatively
Secondary outcome [2] 408505 0
Enhanced Recovery After Surgery measured by oral fluids, early mobilisation, light diet, time to first flatus, time to first bowel motion
Timepoint [2] 408505 0
Post-operative stay
Secondary outcome [3] 408751 0
Quality of Life (SF-36 short form)
Timepoint [3] 408751 0
Pre-operative and 6 weeks, 6 months and 1 year post-operative.

Eligibility
Key inclusion criteria
To be eligible to enter the study all patients must satisfy the following criteria:
1. Adult aged 18 to 80 years of age
2. Undergoing Robot-Assisted Radical Cystectomy (RARC) for bladder cancer (and requiring either ileal conduit or neobladder) or RARC for non-functioning lower urinary tract requiring urinary diversion
3. Oncologically suitable for robotic cystectomy ie localised bladder cancer
Non-invasive disease - Certain high risk high grade NMIBC T1 disease
MIBC T2-T4N1M0
4. Clinically suitable for robotic cystectomy ie deemed surgical fit for a major operation as deemed by anaesthetic pre-operative assessment
5. Cognitively able to give written informed consent for participation
6. Elective procedure
7. Salvage cystectomy cases will be included where primary treatment with radiation has failed and the patient is oncologically and clinically suitable for robotic cystectomy.
8. Concomitant urethrectomy patients will be included
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they present the following exclusion criteria:
1. The patient lacks the ability to consent for themselves
2. Patient or tumour factors precluding robotic surgery (including not medically fit for surgery, extensive previous abdominal surgery, metastatic disease or potentially unresectable locally advanced disease)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment to the Robot Assisted Radical Cystectomy (RARC) procedure with intra or extra-abdominal urinary diversion will be carried out centrally and will be randomly determined by computer generated code. Randomisation of patients to study group will occur using stratification and in blocks of 2 and 4 by study site. Each site will have their own randomisation schedule and a sub-group analysis will be performed at the conclusion of the study to test for difference between sites. Random assignment will be generated just prior to the operation. Data collectors and study personnel will be blinded to randomisation assignments, including when collecting follow up data. Central randomisation will be carried out using a randomisation schedule within the REDCap Database.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Clinically relevant baseline variables will be tabulated and compared between groups. Categorical variables will be compared between groups using the chi-squared test (frequencies and proportions). Continuous variables will be compared using t-test (means) or Wilcoxon 2-sample test (median). All data will be stored in a REDCap database and statistical analysis will be performed using SPSS version 22 (SPSS Inc., Chicago, IL, USA).
Sample size
We are planning a study of independent cases and controls with 1 control per case. Prior data indicate that the mean length of stay (LOS) among patients undergoing extracorporeal urinary diversion is 10 days (+/- 3 days standard deviation). We anticipate that participants in the intervention arm will have on average a LOS two days shorter (8 days) than the mean of the control arm (10 days). Two days was considered a clinically important difference between the surgeons involved as well as patients whose feedback was sought. The two days difference was used for the sample size calculation based on a combination of the literature and surgeons’ experience to date of comparing RARC with intracorporeal urinary diversion to open radical cystectomy. Moreover, a trend of superior LOS of at least two days associated with RARC has been noted amongst the participating centres to date when examining retrospective data. If the true difference in the experimental and control means is 2 days (LOS), we will need to study 36 experimental subjects and 36 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8 (80%). The Type I error probability associated with this test of this null hypothesis is 0.05. The sample size calculation was performed using PS Sample Size Calculator Software with the consultation of an SLHD Biostatistician. We will perform either a Mann-Whitney Test or a T-Test to compare a difference in mean LOS between the arms. A T-Test will be used for data which satisfies a normal distribution, and a Mann-Whitney Test if not.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2022
Actual
28/10/2022
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
72
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22158 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 22156 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 22159 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 22155 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 22157 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 37310 0
2170 - Liverpool
Recruitment postcode(s) [2] 37308 0
2050 - Camperdown
Recruitment postcode(s) [3] 37311 0
2747 - Kingswood
Recruitment postcode(s) [4] 37309 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 311190 0
Other Collaborative groups
Name [1] 311190 0
Institute of Academic Surgery
Country [1] 311190 0
Australia
Primary sponsor type
Hospital
Name
Department of Urology Royal Prince Alfred Hospital (RPAH)
Country
Australia
Secondary sponsor category [1] 312624 0
None
Name [1] 312624 0
Country [1] 312624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310723 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310723 0
Ethics committee country [1] 310723 0
Australia
Date submitted for ethics approval [1] 310723 0
16/03/2022
Approval date [1] 310723 0
05/04/2022
Ethics approval number [1] 310723 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 118642 0
Dr Scott Leslie
Address 118642 0
Missenden Medical Centre Suite 7B Level 1 54-60 Briggs St Camperdown 2050, NSW
Country 118642 0
Australia
Phone 118642 0
+61 02 9519 1331
Fax 118642 0
+61 02 9475 5234
Email 118642 0
info@scottleslie.com.au
Contact person for public queries
Name 118643 0
Jacob Bird
Address 118643 0
Royal Prince Alfred Hospital, Level 9, Building, 89 Missenden Rd, Camperdown NSW 2050
Country 118643 0
Australia
Phone 118643 0
+61 02 9515 3204
Fax 118643 0
Email 118643 0
Jacob.Bird@health.nsw.gov.au
Contact person for scientific queries
Name 118644 0
Jacob Bird
Address 118644 0
Royal Prince Alfred Hospital, Level 9, Building, 89 Missenden Rd, Camperdown NSW 2050
Country 118644 0
Australia
Phone 118644 0
+61 02 9515 3204
Fax 118644 0
Email 118644 0
Jacob.Bird@health.nsw.gov.au

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: At this point in time, the IPD will not be shared. This may change during the trial's recruitment/ analysis stage.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.