Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study (Oslo-CoMet)
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|ClinicalTrials.gov Identifier: NCT01516710|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : January 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Secondary Malignant Neoplasm of Liver Colorectal Neoplasms||Procedure: Open liver resection Procedure: Laparoscopic liver resection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||December 2025|
Active Comparator: Open liver resection
Patients will be operated with open liver resection
Procedure: Open liver resection
Patients will be operated with open liver resection for colorectal metastasis
Active Comparator: Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
Procedure: Laparoscopic liver resection
Patients will be operated with laparoscopic liver resection
- 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
- 5 year survival [ Time Frame: 5 years after surgery ]
5 year survival
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516710
|Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital|
|Oslo, Norway, 0424|
|Study Chair:||Bjørn Edwin, MD, PhD||Oslo University Hospital - The Interventional Centre|
|Principal Investigator:||Bjorn Edwin, MD, PhD||Oslo University Hospital - The Interventional Centre|