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Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

NCT01516710 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-05-10

Study results available
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Summary

The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study. The study will include all non-anatomic liver resections in our institution.

The primary end point is that the use of laparoscopic technique significantly can reduce the frequency of complications to liver resection. Secondary end points are 5-year survival, immediate surgical outcomes, quality of life and degree of impairment of the immune system.

Conditions

  • Secondary Malignant Neoplasm of Liver
  • Colorectal Neoplasms

Interventions

PROCEDURE

Open liver resection

Patients will be operated with open liver resection for colorectal metastasis

PROCEDURE

Laparoscopic liver resection

Patients will be operated with laparoscopic liver resection

Sponsors & Collaborators

  • Helse Sor-Ost

    collaborator OTHER_GOV

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Bjørn Edwin, MD, PhD · Oslo University Hospital - The Interventional Centre

  • Bjorn Edwin, MD, PhD · Oslo University Hospital - The Interventional Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-04-30
Completion
2025-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01516710 on ClinicalTrials.gov