RoLaCaRT-1: pilot randomised phase II study of robotic vs laparoscopic hemicolectomy for right colon cancer.

BACKGROUND

Previous stage I-III colon cancer trials demonstrated improved peri-operative and similar long-term oncological outcomes with minimally invasive approaches compared with open surgery. Subsequent technical developments, including intracorporeal anastomosis, complete mesocolic excision (CME), refined pathologic grading systems and robotic approaches are increasingly used despite minimal supporting evidence. This international phase II trial aims to assess patient, surgical and pathological outcomes following robotic (RRHC) with laparoscopic right hemicolectomy (LRHC) for right sided colon cancer.

METHODS

Prospective, international multicentre pilot randomised phase II trial for patients with right colon adenocarcinoma, randomised 2:1 to robotic (RRHC) or laparoscopic (LRHC) surgery performed by accredited surgeons. Primary outcome was 90-day surgical morbidity measured using the Comprehensive Complication Index (CCI). Standardised pathology reviews, patient reported quality of life and surgeon task load index data was captured.

RESULTS

RRHC vs. LRHC surgery allocation was 19 vs. 10, mean operative time 3.8 vs. 3.1 h with no operative mortality, all had R0 resection, CME rate 53 vs. 50% and intact mesocolon 94 v 100%. CCI was significantly lower at 30 and 90 days after RRHC (median (Q1, Q3): 0 (0, 9) vs. 21 (21, 26); median difference: 21; 95% CI 9-26; p = 0.005 at 30 days; p = 0.008 at 90 days). No significant differences in pathological nor quality of life data was observed. Surgeons task load data tended to favour robotic procedures. Median follow-up was 6 months. Limited funding led to early study closure.

CONCLUSIONS

RRHC improved short-term surgical morbidity and surgeon physical demand and performance whilst obtaining similar quality of life and pathological specimen quality compared to LRHC for right sided colon cancer, supporting the case for larger randomised trials.

TRIAL REGISTRATION: ACTRN12620001378910.