Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001386729
Ethics application status
Approved
Date submitted
20/10/2022
Date registered
28/10/2022
Date last updated
1/06/2024
Date data sharing statement initially provided
28/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Trial assessing the safety and feasibility of major soft tissue abdominal resections using the da Vinci Xi surgical robot.
Scientific title
Clinical Trial assessing the safety and feasibility of performing robotic-assisted multivisceral complete soft tissue extended resections (CSTER) in adults with advanced or recurrent abdominal tumours.
Secondary ID [1] 307840 0
NIL
Universal Trial Number (UTN)
U1111-1281-9288
Trial acronym
RoboSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced abdominal cancers 327449 0
Recurrent abdominal cancers 327450 0
Condition category
Condition code
Cancer 324567 324567 0 0
Bladder
Cancer 324568 324568 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 324569 324569 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 324570 324570 0 0
Bowel - Anal
Cancer 324571 324571 0 0
Cervical (cervix)
Cancer 324572 324572 0 0
Womb (Uterine or endometrial cancer)
Cancer 324573 324573 0 0
Neuroendocrine tumour (NET)
Cancer 324574 324574 0 0
Penile (penis)
Cancer 324575 324575 0 0
Prostate
Cancer 324576 324576 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in the RoboSTER trial is the use of the da Vinci Xi surgical robot to resect advanced or recurrent abdominal tumours (intervention name: robot-assisted multivisceral complete soft tissue extended resection). Intra-corporeal abdominal tumour resection (ICATR) involves performing resection using the Da Vinci Xi Surgical Robot's arms internally, within the body. The majority of the surgery is performed by a colorectal surgeon, however urological surgeons and gynaecological surgeons are often involved and perform specialty specific procedures as parts of the overall surgery (ie: a urologist may perform a radical cystectomy). Abdominal tumour resection involves excision of the tumour and associated attached viscera, this may include bowel, and genitourinary organs. The surgical approach for ICATR follows standardised oncological principles to obtain clear surgical margins and appropriate resection of draining lymph node tissue, as performed for the traditional open approach (please see Comparator/Control Treatment section). The use of the robotic device will be confined to the instrument’s limitations, all remaining components of the surgery will be performed via routine practice. Reconstruction of gastrointestinal and urinary systems will be undertaken using a minimally invasive approach. The approximate duration of the intervention will be 13 hours, however this depends on each individual case. Adherence to the intervention is monitored by patient surgical case reports within electronic medical records and intra-operative surgical forms.
Intervention code [1] 324307 0
Treatment: Surgery
Comparator / control treatment
The comparator in the RoboSTER trial is a propensity-matched cohort of traditional (open) multivisceral complete soft tissue extended resection patients from an existing database. This existing database (X13-0283 PESQI) has collected pelvic exenteration data from RPA Hospital since 1994 and continues to do so. Age, gender and pelvic compartment metrics will be used to compare the trial participants to the comparable non-participant cohort. The surgical approach achieves the same purpose as in the intervention (ie radical complete tumour resection) via a large midline abdominal incision. Abdominal tumour resection involves excision of the tumour and associated attached viscera, this may include bowel, and genitourinary organs.

The comparator treatment is extracorporeal, this involves removing all pelvic visceral organs en bloc. It is possible to excise the central compartment of the pelvis en bloc with another contiguous compartment (anterior, posterior, or lateral), leaving uninvolved compartments undissected depending on tumour involvement. Following a midline laparotomy confirming no unexpected metastatic disease or evidence of peritoneal carcinomatosis, the initial approach focuses on preparing the pelvis for dissection. This involves mobilisation of the left colon along its anatomical plane, high ligation of the inferior mesenteric artery in cases of locally advanced primary rectal cancer, and colonic transection at an appropriate site. This allows the abdominal contents to be packed away and the pelvis to be easily accessed.

Attention is then turned to the pelvis. The posterior total mesorectal excision (TME) plane can usually be developed to the pelvic floor, although this plane may be less distinct in the setting of prior surgery. Importantly, this TME plane is not followed laterally as would be the case in an anterior resection; rather, the ‘extra-ureteric’ plane is developed such that the lateral pelvic dissection is performed ‘outside’ the ureters (and ureterohypogastric fascia), but ‘inside’ the internal iliac vessels. Here, the visceral branches of the internal iliac vessels (anterior division) are individually ligated and transected distally along their course, and this lateral plane then developed to the pelvic floor. Anteriorly, the bladder is mobilised by dissecting the retropubic space of Retzius and taken en bloc. Urinary diversion is usually performed using an ileal conduit.
Control group
Historical

Outcomes
Primary outcome [1] 332400 0
Safety of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection.
Safety of robotic surgery will be measured by the overall 30-day complication rate, calculated from the time surgery begins. Clavien-Dindo Grading System will be used to determine the 30-day complication rate. Complications will be collected by surgeon completed postoperative clinical data form alongside electronic medical records.
Note: all primary outcomes have equal weighting.
Timepoint [1] 332400 0
30 day time period, from when surgery commences.
Primary outcome [2] 332916 0
Feasibility of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection.
Feasibility will be determined firstly by the cumulative time taken for eligible patient recruitment to the intervention. The eligibility date will be collected from patient consultations (screening form) and the trial inclusion date from the date of consent (consent form).
Timepoint [2] 332916 0
Time from first eligible consultation with surgeon until signing of the consent form for inclusion in the research trial.
Primary outcome [3] 332917 0
Feasibility of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection.
Feasibility will be determined secondly by treatment retention, defined as the proportion of patients to not cross over to conventional open surgery (pre-operatively) in the absence of any clinical indication. Treatment retention will be collected from patient surgical records and intraoperative clinical data forms.
Timepoint [3] 332917 0
Peri/intra-operative
Secondary outcome [1] 413338 0
Intra-operative clinical data (operative times, blood loss, conversion to open surgery, complication rate) will be assessed together as a composite measure. This data will be collected from both an intra-operative clinical data form completed by the surgeon and from patient surgical case records.
Potential complications:
1. Surgical injury
2. Heavy bleeding
3. Robotic malfunction
Timepoint [1] 413338 0
Data will be collected during the intraoperative period
Secondary outcome [2] 413339 0
Quality of Life will be assessed using the Short Form-36.
Timepoint [2] 413339 0
Pre-operative, then 6 weeks, and 6 months post-operative.
Secondary outcome [3] 415099 0
Assessment of oncological outcome, with a focus on R0 resection rate. This metric will be collected from the postoperative clinical data form completed by the surgeon.
Timepoint [3] 415099 0
Within 30 days from surgery (once pathology becomes available to the surgeon).

Eligibility
Key inclusion criteria
1. Adults aged 18 years or older
2. Cognitively able to give written informed consent for participation
3. Patients who have one of the following pathologies, and who are deemed by the Pelvic Exenteration MDT as being suitable for robotic multivisceral complete soft tissue extended resection:
a. Primary pelvic malignancy
b. Locally recurrent cancer of the central compartment
c. Colovesical, rectourethral or rectovaginal fistulae
4. Elective procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients unable or unwilling to undergo pre and post-operative evaluation as per the study protocol
2. Patient and/or disease factors precluding robotic assisted multivisceral soft tissue extended resections such as:
a. Previous multiple complex abdominal surgeries
b. Bony resection required as part of the extended resection
c. Vascular reconstruction required as part of the extended resection
d. Other factors as determined by the treating surgeon or Pelvic Exenteration MDT

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to assess the safety and feasibility of robotic multivisceral soft tissue extended resection in 20 patients. Participants who underwent Robotic multivisceral soft tissue extended resection will be compared to a propensity matched cohort of patients who underwent conventional open procedures. Length of stay as well as morbidity and oncological outcomes will be examined. We will perform either a Mann-Whitney Test or a T-Test to compare a difference in means between the cohorts. 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
1/07/2023
Actual
16/10/2023
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23024 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23025 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 38345 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 312115 0
Hospital
Name [1] 312115 0
Colorectal Department at Royal Prince Alfred Hospital
Country [1] 312115 0
Australia
Funding source category [2] 312511 0
Other Collaborative groups
Name [2] 312511 0
Surgical Outcomes Research Centre/ Institute of Academic Surgery RPAH
Country [2] 312511 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050, Australia
Country
Australia
Secondary sponsor category [1] 313638 0
None
Name [1] 313638 0
Address [1] 313638 0
Country [1] 313638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311515 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311515 0
50 Missenden Rd, Camperdown NSW 2050
Ethics committee country [1] 311515 0
Australia
Date submitted for ethics approval [1] 311515 0
27/06/2022
Approval date [1] 311515 0
23/08/2022
Ethics approval number [1] 311515 0
Protocol no. X22-0195 & 2022/ETH00064

Summary
Brief summary
RoboSTER is a prospective cohort trial designed to evaluate the outcomes following robotic removal of pelvic tumours and attached organs during multivisceral complete soft tissue extended resections (STER). The procedure is split into three parts, Firstly, there is removal of the bowel, then removal of the bladder, +/- prostate (male) or gynaecological organs (female) as well as lymph nodes. The second part involves reconstruction of a new urinary tract (urinary diversion) using a section of small bowel attached to the ureters to drain urine produced by the kidneys. The third part involves construction of a faecal diversion, ileostomoy/colostomy, using a section in the bowel to drain faecal matter produced in the intestines.

The main objective is to investigate whether performing the operation inside the body (via a "keyhole surgery approach") with robotic assistance (using the da Vinci Xi surgical robot) is safe and feasible.

Who is it for?
You may be eligible for this study if you are aged over 18 years, and are undergoing an elective robotic multivisceral complete soft tissue extended resections for pelvic cancers.

Study details
All participants will undergo a multivisceral complete soft tissue extended resection using robotic surgical techniques. This will involve using the robotic equipment to perform the resection, and is anticipated to take approximately 13 hours to complete. For all participants conversion to traditional approach rates, quality of life measures, morbidity data and other clinical data (ie: blood loss, oncological outcomes etc) will be recorded to test the safety and feasibility of the approach.

It is hoped that this study may demonstrate that intracorporeal pelvic tumour removal following robotic multivisceral complete STER is a safe and feasible approach and may result in better patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121370 0
Dr Peter Lee
Address 121370 0
Missenden Medical Centre
Suite 415/100 Carillon Ave, Newtown NSW 2042
Country 121370 0
Australia
Phone 121370 0
+61 02 8580 0489
Fax 121370 0
+61 02 9519 1806
Email 121370 0
sue.drlee@gmail.com
Contact person for public queries
Name 121371 0
Mr Jacob Bird
Address 121371 0
Royal Prince Alfred Hospital, Level 9, Building, 89 Missenden Rd, Camperdown NSW 2050
Country 121371 0
Australia
Phone 121371 0
+61 02 9515 3204
Fax 121371 0
Email 121371 0
Jacob.Bird@health.nsw.gov.au
Contact person for scientific queries
Name 121372 0
Mr Jacob Bird
Address 121372 0
Royal Prince Alfred Hospital, Level 9, Building, 89 Missenden Rd, Camperdown NSW 2050
Country 121372 0
Australia
Phone 121372 0
+61 02 9515 3204
Fax 121372 0
Email 121372 0
Jacob.Bird@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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.