INTRODUCTION: A minimally invasive approach in colorectal surgery reduces surgical stress compared with open surgery. Today, the gold standard in the treatment of right-sided colonic cancer is a minimally invasive approach, which can be performed with either a "minimally invasive assisted" technique - a combination of open and minimally invasive surgery with an extracorporeal anastomosis (ECA) or with a "totally minimally invasive" technique with intracorporeal anastomosis (ICA). The prevailing technique is ECA, but there is no conclusive evidence on the superiority of one technique over the other, and randomised trials comparing ICA with ECA are warranted. We hypothesised that ICA will yield improved recovery compared with ECA.
METHODS: This is a triple blind, multicentre, randomised controlled trial comparing robotic right colectomy with ECA with robotic right colectomy with ICA. We plan to include 100 patients undergoing elective minimally invasive right colectomies in two colorectal centres in Denmark. The primary outcome is patient-reported post-operative recovery, and secondary outcomes are additional measures of post-operative recovery (pain, analgesics, nausea and vomiting, time to first flatus/bowel movement, length of hospital stay), operative time, intraoperative complications, conversions, readmissions, reoperations, 30- and 90-day morbidity and mortality.
CONCLUSION: The results of this randomised controlled trial will contribute with valuable knowledge on the best surgical management of right-sided colonic cancer.
FUNDING: The study has received unrestricted grants from the Louis-Hansen Foundation, Jacob & Olga Madsen's foundation, Trigon Foundation, Toyota Foundation, Dagmar Marshalls Foundation, Vissing Foundation, The Kjaer Foundation and the Nyegaard foundation.
TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03130166.
|Tidsskrift||Danish medical journal|
|Status||Udgivet - 20 apr. 2021|