RoLaCaRT-1
Research type
Research Study
Full title
Robotic versus Laparoscopic Colon - a Randomized Trial: An international randomised phase II trial comparing robotic-assisted right hemicolectomy versus laparoscopic-assisted hemicolectomy for resection of adenocarcinoma of the caecum, ascending or proximal transverse colon
IRAS ID
293938
Contact name
Jim Khan
Contact email
Sponsor organisation
Australasian Gastro-Intestinal Trials Group (AGITG)
Duration of Study in the UK
5 years, 0 months, 2 days
Research summary
The RoLaCaRT-1 study is an international, multicenter, single blinded, randomized controlled feasibility trial comparing the use of robotic surgery with laparoscopic (keyhole) surgery for the surgical treatment of right-sided colon cancer.
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.
The expected number of patients to be included is 50 patients, in 3 countries, with a 5 year follow-up period with a possible extension to 10 years following re-consent in case of the set-up of RoLaCart-2.The randomization to either the laparoscopic or robotic arm will include blinding of the type of surgery for the patient until the end of the study. Apart from randomization and blinding, the study has no further impact on staging investigations, timing of surgery or any other aspect of the patients’ pre, peri or post-operative care. All decisions remain with the local clinician multi-disciplinary team including when to discharge from hospital.
The clinical data will be recovered from patients medical files, including medical history, previous and current treatments and any complications due to the surgery.
Quality of life will be monitored with validated questionnaires before surgery, post operative, and 1, 3, 6 and 12 months after the surgery. The questionnaires will evaluate global health and overall quality of life.
Pain levels will be assessed by patients completing a brief pain inventory (BPI) at post-operative day 1, 3 and 5.
Time to return to work or unpaid activity will be assessed by the Labour Force Survey at baseline and 30 and 90 days post surgery.The study aim is to determine feasibility and whether the newer robotic technology will allow greater operative advantages which translate to improved rates of “successful surgery” and better patient-oriented clinical outcomes.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0010
Date of REC Opinion
22 Feb 2022
REC opinion
Further Information Favourable Opinion