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RoLaCaRT-1: A Randomized Trial of Robotic Surgery versus Laparoscopic Surgery for Colon Cancer

ABSTRACT: 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. Primary outcome(s): To determine if performing right hemicolectomy robotically compared with laparoscopic hemicolectomy in patients with adenocarcinoma of the caecum, ascending or proximal transverse colon improves surgical morbidity. Surgical morbidity/mortality up to 90 days (as measured by Clavien-Dindo and the Comprehensive Complication Index). .[90 days post-surgery.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Adenocarcinoma (tumour Or Malignant Polyp) Of The Caecum, Ascending Or Proximal Transverse Colon

PROVIDER: 2471593 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: 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. Primary outcome(s): 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.[30 day time period, from when surgery commences.];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).[Time from first eligible consultation with surgeon until signing of the consent form for inclusion in the research trial.];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.[Peri/intra-operative] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

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RoLaCaRT-1: A Randomized Trial of Robotic Surgery versus Laparoscopic Surgery for Colon Cancer

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