Prospective Randomized Study of Laparoscopic Versus Open Liver Resection for Colorectal Metastases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Secondary Malignant Neoplasm of Liver
- Sponsor
- Oslo University Hospital
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- 30 Days Perioperative Morbidity
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
Full protocol is published open access in Trialsjournal: http://www.trialsjournal.com/content/16/1/73
Investigators
Åsmund Avdem Fretland
MD
Oslo University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
30 Days 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
Secondary Outcomes
- 5 Year Survival(5 years after surgery)
- Recurrence Pattern(5 years)
- Postoperative Quality of Life(Up to 2 years)
- Health Economy(1 year)
- Molecular Biology(20 years)
- Severity of Morbidity(30 days)
- Number of Patients That Complete Adjuvant Oncologic Treatment(1 year)
- Immediate Oncologic Outcome(2 months after surgery)
- Readmissions(30 days)
- Incidence of Incisional Hernia(1 year)
- Surgical Trauma and Activation of the Immune System(72 hours)
- Severity of Postoperative Pain(4 months)
- Imaging(5 years)
- Anti-tumor Immunology(20 years)
- Level of Adhesions(2 years)