Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorHaukeland University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgical access

    Procedure/Surgery

    Complications by Clavien Dindo Number of lymph nodes. Disease free and Overall survival

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Access (Open, laparoscopic, robotic)1 intervention
Group B: Extend of lymphadenectomy described by VAS score1 intervention
Group C: Quality of the specimen1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the operation to discharge and readmission within 30 days

Secondary outcomes

1

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

Time frame
Postoperatively
2

Oncological quality will be measured by overall survival and recurrence

Data will be collected from the patient chart up to 5 years after operation

Time frame
Postoperatively up to five years
3

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.

Time frame
2021 to 2024

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

Intuitive Surgical

Collaborator