Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
NCT ID: NCT01516710
Last Updated: 2024-05-10
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
280 participants
INTERVENTIONAL
2012-01-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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http://www.trialsjournal.com/content/16/1/73
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Open liver resection
Patients will be operated with open liver resection
Open liver resection
Patients will be operated with open liver resection for colorectal metastasis
Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
Interventions
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Open liver resection
Patients will be operated with open liver resection for colorectal metastasis
Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Helse Sor-Ost
OTHER_GOV
Oslo University Hospital
OTHER
Responsible Party
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Åsmund Avdem Fretland
MD
Principal Investigators
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Bjørn Edwin, MD, PhD
Role: STUDY_CHAIR
Oslo University Hospital - The Interventional Centre
Bjorn Edwin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital - The Interventional Centre
Locations
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Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
Oslo, , Norway
Countries
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References
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Aghayan DL, Kazaryan AM, Dagenborg VJ, Rosok BI, Fagerland MW, Waaler Bjornelv GM, Kristiansen R, Flatmark K, Fretland AA, Edwin B; OSLO-COMET Survival Study Collaborators. Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial. Ann Intern Med. 2021 Feb;174(2):175-182. doi: 10.7326/M20-4011. Epub 2020 Nov 17.
Fretland AA, Dagenborg VJ, Waaler Bjornelv GM, Aghayan DL, Kazaryan AM, Barkhatov L, Kristiansen R, Fagerland MW, Edwin B, Andersen MH. Quality of life from a randomized trial of laparoscopic or open liver resection for colorectal liver metastases. Br J Surg. 2019 Sep;106(10):1372-1380. doi: 10.1002/bjs.11227. Epub 2019 Jul 19.
Fretland AA, Kazaryan AM, Bjornbeth BA, Flatmark K, Andersen MH, Tonnessen TI, Bjornelv GM, Fagerland MW, Kristiansen R, Oyri K, Edwin B. Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial. Trials. 2015 Mar 4;16:73. doi: 10.1186/s13063-015-0577-5.
Other Identifiers
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2011/1285/REK sør-øst B
Identifier Type: -
Identifier Source: org_study_id
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