Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial.

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.

CEA as a monitor of gastrointestinal malignancy.

Ninety-four patients with carcinoma of the colon have been followed with serial determinations of plasma CEA (carcinoembryonic antigen) levels over a 3-year period using the Hansen assay. Nine hundred twelve CEA determinations have been made in these patients. Plasma CEA levels rose in 90% of the instances of clinical progression documented in these patients. In 30% of patients, this rise indicated progression 6 months or more before it was detected by standard clinical methods. Unfortunately, a few patients never developed elevated CEA levels even though disease clearly progressed. False positive results have also been encountered, with significant elevations occurring in patients who have since remained without evidence of disease for several months. Our data indicate that at least two sequential elevated CEA values, the second being higher, must be a minimal criterion for consideration of possible progression of disease. Even with this standard, we have encountered false positive results in 10% of our patients, indicating recurrence or progression where none has occurred clinically. CEA measurement is of limited usefulness for 30 days after curative surgery, because the elevation of CEA levels due to the original amount of tumor present as well as due to surgery per se may persist for this length of time in a significant number of patients. On the other hand, CEA levels have responded to chemotherapy in close correlation with observed clinical course in those patients with metastatic disease treated in this series. Initial pretherapy CEA values have so far proved to be good prognostic indicators of disease course following complete resection. With an initial CEA value of less than 2.5 ng/ml of plasma, recurrent has been rare (1/20). If the pretreatment CEA was greater than 7.0 ng/ml, it has been the rule (7/9).