Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery. Co-primary endpoints are * Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
304
Removal of incompletely removed early-stage colon cancer
Vestre Viken Hospital
Oslo, Akershus, Norway
RECRUITINGAkershus University Hospital
Oslo, Norway
RECRUITINGMaria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
RECRUITINGSevere adverse events
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
Time frame: 30 days
CRC recurrence or sign of lymph nodes or distant metastases
Rate of CRC recurrence or sign of lymph nodes or distant metastases
Time frame: 3 years
CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment
CRC recurrence or metastases
Time frame: 1 year
CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment
CRC recurrence or metastases
Time frame: 5 years
CRC survival and overall survival at 1,3 and 5 years after study treatment
CRC survival and overall survival
Time frame: 1, 3, 5 years
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment
Severe adverse events
Time frame: 1 year
Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment
mild and moderate adverse events
Time frame: 30 days
Length of hospital stay after study treatment
Hospital stay
Time frame: 30 days
Hospital readmission rate after discharge within 30 days after study treatment
Hospital readmission
Time frame: 30 days
Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection
Technical success
Time frame: 1 day
Duration of the study procedure
Duration of procedure
Time frame: 1 day
Environmental footprint of study procedures at 30 days after study treatment
Carbon dioxide emission in kgCo2 per procedure
Time frame: 30 days
Health related quality of life and functional outcomes after 30 days and one year
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL)
Time frame: 30 days, 1 year
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