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RecruitingLast updated: 2 February 2024

RoLaCaRT-1: The aim of this trial is to compare the use of robotic surgery with laparoscopic ('keyhole') surgery for the treatment of right sided colon cancerAn 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

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 patients with colon cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

RoLaCaRT-1

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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