Tumor removal
ProcedureRemoval of incompletely removed early-stage colon cancer
NCT Number: NCT06057350
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).
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Vestre Viken Hospital, Oslo, Akershus, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Removal of incompletely removed early-stage colon cancer
Time frame: 30 days
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: 3 years
Rate of CRC recurrence or sign of lymph nodes or distant metastases
Time frame: 1 year
CRC recurrence or metastases
Time frame: 5 years
CRC recurrence or metastases
Time frame: 1, 3, 5 years
CRC survival and overall survival
Time frame: 1 year
Severe adverse events
Time frame: 30 days
mild and moderate adverse events
Time frame: 30 days
Hospital stay
Time frame: 30 days
Hospital readmission
Time frame: 1 day
Technical success
Time frame: 1 day
Duration of procedure
Time frame: 30 days
Carbon dioxide emission in kgCo2 per procedure
Time frame: 30 days, 1 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: 5 years
Costs in dollars as compared to effectiveness
Contact information is provided by the study sponsor or research team.
Michael Bretthauer, MD PhD
CONTACT
Nastazja Pilonis, MD PhD
CONTACT
Norwegian Department of Health and Social Affairs
Other Gov
Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
Acronym: SCAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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