Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer

Summary

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).

Conditions

• Complication
• Quality of Life
• Surgical Procedure, Unspecified
• Lymph Node Metastases
• Circulating Tumor Cell

Interventions

PROCEDURE

Open surgery

PROCEDURE

Right colectomy

PROCEDURE

Laparoscopic surgery

PROCEDURE

Central lymphadenectomy and vascular ligation

Sponsors & Collaborators

• Helse-Bergen HF

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• Haraldsplass Deaconess Hospital

  lead OTHER

Principal Investigators

• Kristin B. Lygre, M.D · Haraldsplass Deaconess Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2022-01-31

Completion

2026-12-31

Countries

• Norway

Study Locations