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Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study (Oslo-CoMet)

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Active, not recruiting

Conditions

Secondary Malignant Neoplasm of Liver
Colorectal Neoplasms

Treatments

Procedure: Laparoscopic liver resection
Procedure: Open liver resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01516710
2011/1285/REK sør-øst B

Details and patient eligibility

About

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.

Full description

Full protocol is published open access in Trialsjournal:

http://www.trialsjournal.com/content/16/1/73

Enrollment

280 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients eligible for radical liver resection without formal liver resection or without assistance of radiofrequency ablation

Exclusion criteria

  • Inability to give written informed concent
  • Patients with tumors that can't be resected without reconstruction of vessels or bile ducts
  • Patients with tumors that can't be resected without 1)formal liver resection 2)combination with radiofrequency ablation
  • Patients with extrahepatic metastasis except resectable metastasis in lungs and adrenals
  • Pre- and peroperative diagnosis of non radically treatable disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

280 participants in 2 patient groups

Open liver resection
Active Comparator group
Description:
Patients will be operated with open liver resection
Treatment:
Procedure: Open liver resection
Laparoscopic liver resection
Active Comparator group
Description:
Patients will be operated with laparoscopic liver resection
Treatment:
Procedure: Laparoscopic liver resection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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