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Clinical Trials in Norway / NCT03776591
Active, not recruiting Not applicable

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

NCT03776591 · tracked via the Priya Life Science Norway tracker
Sponsor
Haraldsplass Deaconess Hospital
Phase
Not applicable
Started
2016-09-01
Last updated
2026-05-14

Condition(s) studied

ComplicationQuality of LifeSurgical Procedure, UnspecifiedLymph Node MetastasesCirculating Tumor Cell

Investigational drug(s) / intervention(s)

Open surgeryRight colectomyLaparoscopic surgeryCentral lymphadenectomy and vascular ligation

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * • 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 Exclusion Criteria: * • Patients with recurrent cancer after previous surgery * Patients with synchronous distant metastasis * Patients with ongoing oncological treatment due to other cancer

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Haraldsplass Bergen Norway

More Haraldsplass Deaconess Hospital trials in Norway

The National Lipedema Study Active, not recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03776591 on ClinicalTrials.gov ↗ ← All trials in Norway