NCT03776591Active, not recruiting
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
The primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment strategy both surgically and oncological and to assess and predict treatment outcome. The aim of this study is to compare short and long-term outcomes between open D3 and laparoscopic CME (complete mesocolic excision) with CVL (central vascular ligation) right colectomy for right-sided colon cancer. Our primary hypothesis is that laparoscopic surgery improves quality of life by reducing pain, postoperative complications and thereby reduces hospital stay and convalescence. On the other hand it is to prove non-inferiority of the laparoscopic group compared to the open group by means of oncological outcome (survival, recurrence). Secondary aim is to evaluate surgical quality by comparing actual vascular stump length between the two groups by postoperative CT and compare number of lymph nodes removed with the specimen. With the use of liquid biopsy we want to detect circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) and evaluate their value as tumor markers by comparing the prognostic and predictive value. The hypothesis is that ctDNA and CTCs are more sensitive than standard parameters and imaging (CT CEA).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 6 Dec 2018
- Start date
- 1 Sept 2016
- Primary completion date
- 31 Jan 2022
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT03776591
What you commit to
- Study type: Interventional
- Participants enrolled: 128
- From 1 Sept 2016 to the primary completion date, 31 Jan 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Patients with recurrent cancer after previous surgery
- Patients with synchronous distant metastasis
- Patients with ongoing oncological treatment due to other cancer
Who the study is looking for
- • Patients with malignant tumor of the right colon (cecum, ascending colon, right flexure and right transverse) at CT, colonoscopy.
- Patients medically cleared by anesthesiologist for general anesthesia and oncological radical resection
- Patients ≤ 85 years
- Signed informed consent form
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haraldsplass Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.