About this trial
Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with malignant tumor of the right colon at CT and/or colonoscopy.
Confirmed adenocarcinoma
Patients medically cleared by anesthesiologist for general anesthesia and oncological radical resection
Informed consent
Disqualifiers
Patients under 18 years
Patients with recurrent cancer after previous surgery
Patients with ongoing treatment due to other cancer
Trial population
All patients with confirmed adenocarcinom of the right colon admitted to the hospital
Trial design
Cohort
Prospective
Treatments tested in this trial
Surgical access
Procedure/SurgeryComplications by Clavien Dindo Number of lymph nodes. Disease free and Overall survival
Treatment groups
Trial outcomes
Primary outcomes
Surgical complications defined by Calvien Dindo II to V
The primary aim of the project is to compare the impact of surgical radicality on clinical outcomes for right-sided colon cancer. The Clavien Dindo classification is a validated system ranging from I-V.
Secondary outcomes
Surgical quality described by the specimen quality and number of lymph nodes harvested
Specimen quality will be assessed by the surgeon postoperatively by a validated classification system for complete mesocolic excision in right-sided colon cancer (Benz S et al) and the number of lymph nodes
Oncological quality will be measured by overall survival and recurrence
Data will be collected from the patient chart up to 5 years after operation
Quality of life after surgery measured with the 15D instrument
The QoL questionnaire 15D instrument by Sintonen is a validated self-reported instrument. The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure.
Sponsors and contacts
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Haukeland University Hospital
Lead sponsor
Intuitive Surgical
Collaborator