Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000331730p
Ethics application status
Not yet submitted
Date submitted
11/10/2021
Date registered
23/02/2022
Date last updated
23/02/2022
Date data sharing statement initially provided
23/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ROBOTIC PELVIC SURGERY (ROPES) I: Robotic Extended Resection for Locally Advanced and Recurrent Pelvic Malignancy: An IDEAL 2B Prospective Study to Design a Phase III Randomised Controlled Trial
Scientific title
ROBOTIC PELVIC SURGERY (ROPES) I: Robotic Extended Resection for Locally Advanced and Recurrent Pelvic Malignancy: An IDEAL 2B Prospective Study to Design a Phase III Randomised Controlled Trial
Secondary ID [1] 305498 0
nil
Universal Trial Number (UTN)
U1111-1270-2700
Trial acronym
ROPES I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced pelvic malignancy 323889 0
Recurrent pelvic malignancy 323890 0
Condition category
Condition code
Cancer 321399 321399 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 321400 321400 0 0
Bladder
Cancer 321401 321401 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 321402 321402 0 0
Cervical (cervix)
Cancer 321403 321403 0 0
Prostate
Cancer 321404 321404 0 0
Womb (Uterine or endometrial cancer)
Cancer 321405 321405 0 0
Bowel - Anal
Cancer 321431 321431 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This IDEAL 2B observational study will assess the current use of robotic assisted extended resection for locally advanced and recurrent pelvic malignancies. Patients being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study. This study is observational and so it will not change which treatment the patient receives.

INDICATION: Locally advanced or recurrent pelvic cancer requiring extended resection

PRIMARY OBJECTIVES:
To determine the current case volume and current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres.

SECONDARY OBJECTIVES:
1. To obtain pilot outcome data including clinical, pathological and patient reported outcome measures (PROMS).
2. To assess feasibility and plan a future prospective phase III randomised controlled trial of robotic versus non robotic extended resection in locally advanced or recurrent pelvic cancer.
TRIAL DESIGN: Observational IDEAL 2B prospective study

OBSERVATIONAL STUDY ARMS:
Cases: Robotic extended resection for locally advanced or recurrent pelvic malignancy
Controls: Non-robotic extended resection for locally advanced or recurrent pelvic malignancy

For participants there will be no change to their treatment. Their data will be collected from medical records. They will be invited to participate in PROMS questionnaires at:
1. 7 days post operatively
2. 3 months
3. 6 months
4. One year
Measures used will take approximately 30 minutes at each time point:
Generic Measures:
• EORTC QLQC30- This is a questionnaire specifically designed to assess the QOL of cancer patients.
• QOR15- Quality of Recovery - This assesses patient quality of recovery after anaesthesia and surgery.
• EQ5D – European Quality of Life-5 Dimensions Questionnaire – This questionnaire will enable health economic analysis
Pain Scores
• Verbal Numeric Rating Scale (VNRS) – to assess pain score at day 3 and day 7 post operatively and then at the same time points as the other PROMS.
All participants being considered for a robotic approach with locally advanced or recurrent pelvic malignancy will be included in the study, and will be observed for up to 12 months post-enrolment. They will be consented to be contacted in the future and invited to participate in longer term follow up studies.


Intervention code [1] 321900 0
Not applicable
Comparator / control treatment
Patients undergoing standard non-robotic extended resection for locally advanced or recurrent pelvic malignancy.
Control group
Active

Outcomes
Primary outcome [1] 329171 0


To determine the current case volume of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres. This will be assessed by a study specific questionnaire and data will be entered onto redcap at participating sites.
Timepoint [1] 329171 0
This primary timepoint will be at the time of selection for surgery, i.e. at initial enrolment into the study.
Primary outcome [2] 329172 0
To determine current patient selection criteria of robotic assisted surgery for locally advanced or recurrent pelvic malignancy in expert centres.

The surgical team will enter data on redcap based on a patient selection for robotic surgery questionnaire designed specifically for the study.
Timepoint [2] 329172 0
for the primary end point, it will be assessed at time of selection for surgery
Secondary outcome [1] 402845 0
Pathological Factors - R0 resection and nodes using data linkage to medical records reviewing the pathology report and the operative note
Timepoint [1] 402845 0
at 30 days postoperatively
Secondary outcome [2] 402846 0
Patient reported outcome measures - EORTC QLQC30
Timepoint [2] 402846 0
7 days post operatively, 3 months, 6 months and One year
Secondary outcome [3] 404721 0
Clinical outcome- estimated blood loss - measured in mls from operative note
Timepoint [3] 404721 0
This will be recorded on the day of surgery at the end of the case using the operative details proforma.
Secondary outcome [4] 404722 0
clinical- pain score - verbal numeric rating scale
Timepoint [4] 404722 0
day 1 and day 7 post operatively
Secondary outcome [5] 404723 0
clinical - length of stay (days) using data linkage to medical records
Timepoint [5] 404723 0
Measured on discharge from hospital
Secondary outcome [6] 404724 0
complications- scored using Clavien dindo system
Timepoint [6] 404724 0
30 days post-operatively
Secondary outcome [7] 404725 0
QOR15- Quality of Recovery
Timepoint [7] 404725 0
7 days, 3 months, 6 months and 1 year post operatively
Secondary outcome [8] 404726 0
European Quality of Life-5 Dimensions Questionnaire- EQ5D will be used to assess quality of life - this metric can be used for health economic analysis
Timepoint [8] 404726 0
7 days/ 3 months/6 months/ 1 year post operatively
Secondary outcome [9] 406424 0
Abdominal wall integrity assessed clinically and radiologically at one year at outpatient visit and reviewing routine postoperative surveillance CT's for evidence of hernia - site and symptomatic status will be recorded
Timepoint [9] 406424 0
1 year
Secondary outcome [10] 406425 0
Disease free survival - survival and recurrence will be recorded at 1 year post operatively using data linkage to medical records
Timepoint [10] 406425 0
1 year
Secondary outcome [11] 406426 0
EORTC QRQC30 will be used as a disease specific quality of life metric and administered as a questionnaire to patients
Timepoint [11] 406426 0
day 7, 3 months, 6 months and one year post operatively

Eligibility
Key inclusion criteria
1. Patients with locally advanced or recurrent pelvic malignancy requiring extended resection
2. Patients in expert centres where a robotic approach is offered to selected cases with locally advanced or recurrent pelvic malignancy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not proceed to surgery.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be summarised descriptively using appropriate frequencies and summary statistics, estimating levels of variability. The independent student t-test will be used to examine differences in mean scores in two groups and the one-way analysis of variance (ANOVA) for more than two groups. Survival rates will be estimated using the Kaplan-Meier method. Differences between Kaplan Meier curves will be tested using the log rank test. Redcap and Microsoft excel will be used for data handling, and statistical modelling will be done using SPSS. Qualitative Analysis will be performed using NVIVO. Thematic content analysis will be utilised to analyse qualitative data. Statistical significance will be defined as a p value =0.05 in all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20703 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 35505 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 24475 0
United Kingdom
State/province [1] 24475 0
Country [2] 24476 0
India
State/province [2] 24476 0
Country [3] 24477 0
France
State/province [3] 24477 0
Country [4] 24478 0
Japan
State/province [4] 24478 0

Funding & Sponsors
Funding source category [1] 309857 0
Self funded/Unfunded
Name [1] 309857 0
Country [1] 309857 0
Primary sponsor type
Individual
Name
Satish Warrier
Address
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000, Australia
Country
Australia
Secondary sponsor category [1] 310894 0
Individual
Name [1] 310894 0
Alexander Heriot
Address [1] 310894 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000, Australia
Country [1] 310894 0
Australia
Secondary sponsor category [2] 310895 0
Individual
Name [2] 310895 0
Helen Mohan
Address [2] 310895 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC 3000, Australia
Country [2] 310895 0
Australia
Other collaborator category [1] 282016 0
Individual
Name [1] 282016 0
Deena Harji
Address [1] 282016 0
Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL, UK
Country [1] 282016 0
United Kingdom

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309596 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 309596 0
Ethics committee country [1] 309596 0
Australia
Date submitted for ethics approval [1] 309596 0
28/02/2022
Approval date [1] 309596 0
Ethics approval number [1] 309596 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114710 0
Dr Satish Warrier
Address 114710 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
VIC 3000 Australia
Country 114710 0
Australia
Phone 114710 0
+61 0488054238
Fax 114710 0
Email 114710 0
[email protected]
Contact person for public queries
Name 114711 0
Helen Mohan
Address 114711 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
VIC 3000 Australia
Country 114711 0
Australia
Phone 114711 0
+61 0411101743
Fax 114711 0
Email 114711 0
[email protected]
Contact person for scientific queries
Name 114712 0
Alexander Heriot
Address 114712 0
Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
VIC 3000 Australia
Country 114712 0
Australia
Phone 114712 0
+61 0385595000
Fax 114712 0
Email 114712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality/data protection


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13485Study protocol  [email protected] 382913-(Uploaded-08-01-2022-14-18-55)-Study-related document.docx



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.