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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Åsmund Avdem Fretland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01516710
First received: January 13, 2012
Last updated: January 4, 2017
Last verified: January 2017
January 13, 2012
January 4, 2017
January 2012
April 2016   (Final data collection date for primary outcome measure)
Perioperative morbidity [ Time Frame: Within 30 days after surgery ]
This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity within the first 30 days is the primary outcome (morbidity, yes/no), and will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al, by the Accordion system and by the Comprehensive Complication Index
Perioperative morbidity [ Time Frame: Within 4 months after surgery ]
This study aims to compare major intraoperative and postoperative parameters in patients randomized to either laparoscopic or open liver resection. Pre- and perioperative events relevant for surgical outcomes will be registered. The following intraoperative parameters will be compared: operative time, blood loss, blood transfusion, while intraoperative incidents will be classified according to the Satava classification. Morbidity will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al.
Complete list of historical versions of study NCT01516710 on ClinicalTrials.gov Archive Site
  • 5 year survival [ Time Frame: 5 years after surgery ]

    5 year survival

    • overall
    • disease free
    • recurrence free
  • Recurrence pattern [ Time Frame: 5 years ]
    Pattern of recurrence in liver and extrahepatic. Studied by postoperative CT every 4 months for 2 years and every 6 months for the following 3 years. Local recurrence and new tumors will be recorded.
  • Immediate oncologic outcome [ Time Frame: 2 months after surgery ]
    Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.
  • Postoperative quality of life [ Time Frame: Up to 2 years ]
    Evaluation of postoperative quality of life at baseline, 1 month, 4 months and 2 years using the SF-36 and the EORTC qlq-30 lmc-21 forms
  • Surgical trauma and activation of the immune system [ Time Frame: 72 hours ]
    Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperative time points.
  • Health economy [ Time Frame: 1 year ]
    We intend to compare overall cost of treatment for the hospital and for the health care system
  • Severity of postoperative pain [ Time Frame: 4 months ]
    To compare pain the first 5 postoperative days, at 1 month and 4 months. Patients in the open group will be randomized to receiving either a patient controlled analgesic pump containing opioids, or a patient controlled epidural analgesic pump. In laparoscopic group all patients will receive a PCA.
  • Molecular biology [ Time Frame: 20 years ]
    The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.
  • Anti-tumor immunology [ Time Frame: 20 years ]
    The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
  • Imaging [ Time Frame: 5 years ]
    The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases.
  • Severity of morbidity [ Time Frame: 30 days ]
    Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system
  • Level of adhesions [ Time Frame: 2 years ]
    Level of adhesions will be recorded during repeated liver resection in patients formerly randomized to open or laparoscopic liver resection. a modified version of the peritoneal adhesion index will be used for scoring.
  • Number of patients that complete adjuvant oncologic treatment [ Time Frame: 1 year ]
    Time from operation to initiation of oncologic treatment, and the total number of courses given will be recorded and compared between the groups.
  • Readmissions [ Time Frame: 30 days ]
    Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.
  • Incidence of incisional hernia [ Time Frame: 1 year ]
    CT scans will be performed to examine for incisional hernia 1 year after surgery
  • 5 year survival [ Time Frame: 5 years after surgery ]

    5 year survival

    • overall
    • disease free
    • recurrence free
  • Recurrence pattern [ Time Frame: 5 years ]
    Pattern of recurrence in liver and extrahepatic.
  • Immediate oncologic outcome [ Time Frame: 2 months after surgery ]
    Immediate oncologic outcome is the result of surgical specimen evalutation, evaluation of tumor resection margins.
  • Postoperative quality of life [ Time Frame: 6 months ]
    Evaluation of postoperative quality of life at baseline, 1 month and 6 months
  • Surgical trauma and activation of the immune system [ Time Frame: 72 hours ]
    Evaluation of surgical trauma caused by open and laparoscopic resection by means of analyzing complement and cytokine activation at set perioperatiev time points.
  • Health economy [ Time Frame: 1 year ]
    We intend to compare overall cost of treatment for the hospital and for the helath care system
  • Postoperative pain [ Time Frame: 1 month ]
    To compare pain on the 2. postoperative day and after 1 month.
  • Molecular biology [ Time Frame: 20 years ]
    The aim is to perform molecular characterization of biological samples harvested perioperatively and during follow-up, and to correlate results with clinical end points.
  • Anti-tumor immunology [ Time Frame: 20 years ]
    The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors
  • Imaging [ Time Frame: 5 years ]
    The aim is to evaluate two new imaging methods, CT perfusion of liver and LIME-PET, in order to optimize the preoperative identification of colorectal liver metastases.
Not Provided
Not Provided
 
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study
Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases

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 protocol is published open access in Trialsjournal:

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Secondary Malignant Neoplasm of Liver
  • Colorectal Neoplasms
  • Procedure: Open liver resection
    Patients will be operated with open liver resection for colorectal metastasis
    Other Names:
    • Open liver resection using standard technique:
    • Ligasure
    • CUSA
    • Thunderbeat
    • Autosonix
    • SonoSurg
    • Ultrasound
  • Procedure: Laparoscopic liver resection
    Patients will be operated with laparoscopic liver resection
    Other Names:
    • Laparoscopic liver resection using standardized technique:
    • Ligasure
    • CUSA
    • Thunderbeat
    • Autosonix
    • SonoSurg
    • Laparoscopic ultrasound
  • Active Comparator: Open liver resection
    Patients will be operated with open liver resection
    Intervention: Procedure: Open liver resection
  • Active Comparator: Laparoscopic liver resection
    Patients will be operated with laparoscopic liver resection
    Intervention: Procedure: Laparoscopic liver resection
Fretland ÅA, Kazaryan AM, Bjørnbeth BA, Flatmark K, Andersen MH, Tønnessen TI, Bjørnelv GM, Fagerland MW, Kristiansen R, Øyri 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
December 2025
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01516710
2011/1285/REK sør-øst B
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Not decided yet but results will be public no matter the outcome of the trial
Åsmund Avdem Fretland, Oslo University Hospital
Oslo University Hospital
Helse Sor-Ost
Study Chair: Bjørn Edwin, MD, PhD Oslo University Hospital - The Interventional Centre
Principal Investigator: Bjorn Edwin, MD, PhD Oslo University Hospital - The Interventional Centre
Oslo University Hospital
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP