RoLaCaRT-1: A Randomized Trial of Robotic Surgery versus Laparoscopic Surgery for Colon Cancer
RoLaCaRT-1: 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
Australasian Gastrointestinal Trials Group (AGITG)
50 participants
Aug 20, 2021
Interventional
Conditions
Summary
The aim of this study is to compare the use of robotic surgery with laparoscopic surgery for the surgical treatment of right sided colon cancer. Robotic and laparoscopic operations are called minimally invasive surgery, that is, they use instruments fitted in through small incisions or cuts in the abdomen. The removal of the colon cancer tumour called a hemicolectomy and in this study for right-sided colon cancer it is called a right hemicolectomy. Who is it for? You may be eligible to join this study if you are an adult aged 18 years and older, have adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon that requires surgery. Disease must be confirmed by histological, radiological, endoscopic diagnosis Study Details Participants in this study will be randomly allocated (by chance) to either robotic or laparoscopic surgery. You will have a two to one chance of be allocated robotic surgery. The purpose of the study is to evaluate the surgery and it’s short and longer term outcomes, quality of life, cost effectiveness and surgeons’ experience with the robotic surgery approach. All participants will be monitored for up to 12 months for recovery from surgery, adverse events, quality of life and return to usual activities or work.
Eligibility
Inclusion Criteria7
- Adults with adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. Disease must be confirmed by histological, radiological, endoscopic diagnosis.
- ECOG performance status 0-2.
- Life expectancy of at least 1 year.
- Surgery to be performed within 40 days of randomisation.
- Elective surgery performed with curative intent.
- Signed, written informed consent.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
Exclusion Criteria15
- Evidence of T4 disease invading adjacent organs.
- Pre-operative surgical plan includes division of the middle colic vessels (extended right hemicolectomy) or any other more extensive colectomy procedure.
- Synchronous surgical procedure planned with right hemicolectomy.
- Urgent, unplanned or emergency surgery.
- Palliative surgical intent including non-resection, stoma formation, staging laparoscopy or open and close procedures.
- Prior formation of defunctioning ileostomy as part of treatment for this right colon cancer.
- No plan to create a surgical ileo-colonic anastomosis.
- Neoadjuvant chemotherapy administered to treat this cancer prior to resection.
- Known Crohn’s disease with active terminal ileal disease.
- History of any conditions that would preclude use of a minimally-invasive approach (e.g. multiple previous major laparotomies, severe adhesions, patient co-morbidity).
- Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality.
- Other co-morbidities or conditions that may compromise assessment of key outcomes.
- Significant metastatic disease which would be expected to impact life expectancy of at least 1 year
- 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).
- Pregnancy or lactation.
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Interventions
Surgeon will perform Right hemicolectomy performed by a robotic surgery using the da Vinci Xi surgical robotic A robotic right hemicolectomy is performed with the da VINCI Xi surgical robot using up to four robotic arms to control small instruments introduced into the abdomen through 3 – 6 small incisions on the abdomen measuring around 8mm. One robotic arm is used for a camera. The tumour is removed through another incision (about 5cm to 8cm). The approximate duration of surgery is two hours. Surgeons will be required to electronically record every operation they perform in this study.
Locations(11)
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ACTRN12620001378910