Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
Participants will be randomly allocated to receive either robotic or laparoscopic surgery for the surgical treatment of their cancer. There will be a two in one chance that patients are allocated to receive robotic surgery. This study will evaluate the short and longer term outcomes, quality of life, cost effectiveness and surgeons’ experience with the robotic surgery approach.
Conditions
This trial is treating people with colon cancer
Eligibility
Inclusion
1. Adults with adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. Disease must be confirmed by histological, radiological, endoscopic diagnosis.
2. ECOG performance status 0-2.
3. Life expectancy of at least 1 year.
4. Surgery to be performed within 40 days of randomisation.
5. Elective surgery performed with curative intent.
6. Signed, written informed consent.
7. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
Exclusion
1. Evidence of T4 disease invading adjacent organs.
2. Pre-operative surgical plan includes division of the middle colic vessels (extended right hemicolectomy) or any other more extensive colectomy procedure.
3. Synchronous surgical procedure planned with right hemicolectomy.
4. Urgent, unplanned or emergency surgery.
5. Palliative surgical intent including non-resection, stoma formation, staging laparoscopy or open and close procedures.
6. Prior formation of defunctioning ileostomy as part of treatment for this right colon cancer.
7. No plan to create a surgical ileo-colonic anastomosis.
8. Neoadjuvant chemotherapy administered to treat this cancer prior to resection.
9. Known Crohn’s disease with active terminal ileal disease.
10. History of any conditions that would preclude use of a minimally-invasive approach (e.g. multiple previous major laparotomies, severe adhesions, patient co-morbidity).
11. Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality.
12. Other co-morbidities or conditions that may compromise assessment of key outcomes.
13. Significant metastatic disease which would be expected to impact life expectancy of at least 1 year
14. Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation).
15. Pregnancy or lactation.
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Intuitive Inc.,Australasian Gastro-Intestinal Trials Group (AGITG)
Scientific Title
An international randomised phase II trial comparing surgical outcomes of robotic-assisted right hemicolectomy versus laparoscopic-assisted hemicolectomy for resection of adenocarcinoma of the caecum, ascending or proximal transverse colon
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