Trial Outcomes & Findings for Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study (NCT NCT01516710)

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

280 participants

Primary outcome timeframe

Within 30 days after surgery

Results posted on

2024-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	147	133
Overall Study COMPLETED	143	129
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Liver Resection n=147 Participants 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 n=133 Participants Patients will be operated with laparoscopic liver resection Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection	Total n=280 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 10 • n=5 Participants	67 years STANDARD_DEVIATION 8 • n=7 Participants	66 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	56 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	77 Participants n=7 Participants	164 Participants n=5 Participants
Region of Enrollment Norway	147 Participants n=5 Participants	133 Participants n=7 Participants	280 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days after surgery

Population: Modified intention to treat

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

Outcome measures

Outcome measures
Measure	Open Liver Resection n=144 Participants 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 n=129 Participants Patients will be operated with laparoscopic liver resection Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection
30 Days Perioperative Morbidity	44 Complications Accordion grade 2 or highe	24 Complications Accordion grade 2 or highe

SECONDARY outcome

Timeframe: 5 years after surgery

5 year survival * overall * disease free * recurrence free

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months after surgery

Immediate oncologic outcome is the result of surgical specimen evaluation - evaluation of tumor resection margins.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

We intend to compare overall cost of treatment for the hospital and for the health care system

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 20 years

The aim is to evaluate immunological parameters related to anti-tumor immunity and inflammatory factors

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Severity of complications will be assessed by the Comprehensive Complication Index and the Accordion system

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Readmissions within 30 days after surgery will be recorded, both admissions to Oslo University Hospital and to referring hospitals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

CT scans will be performed to examine for incisional hernia 1 year after surgery

Outcome measures

Outcome data not reported

Adverse Events

Open Liver Resection

Serious events: 10 serious events

Other events: 0 other events

Deaths: 1 deaths

Laparoscopic Liver Resection

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open Liver Resection n=147 participants at risk 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 n=133 participants at risk Patients will be operated with laparoscopic liver resection Laparoscopic liver resection: Patients will be operated with laparoscopic liver resection
Blood and lymphatic system disorders Bleeding	0.68% 1/147 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system	0.75% 1/133 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system
Gastrointestinal disorders Suspected bowel perforation	0.68% 1/147 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Cardiac disorders Cardiac arrest	0.68% 1/147 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Gastrointestinal disorders Fascia dehiscence	1.4% 2/147 • Number of events 2 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Gastrointestinal disorders Small bowel obstruction	1.4% 2/147 • Number of events 2 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Nervous system disorders Stroke	0.68% 1/147 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Blood and lymphatic system disorders Pulmonary embolism	0.68% 1/147 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Gastrointestinal disorders Small bowel perforation	0.00% 0/147 • 30 days Adverse events were systematically collected using the Accordion system	1.5% 2/133 • Number of events 2 • 30 days Adverse events were systematically collected using the Accordion system
General disorders Sudden death	0.68% 1/147 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system	0.00% 0/133 • 30 days Adverse events were systematically collected using the Accordion system
Gastrointestinal disorders Intraabdominal abcess	0.00% 0/147 • 30 days Adverse events were systematically collected using the Accordion system	0.75% 1/133 • Number of events 1 • 30 days Adverse events were systematically collected using the Accordion system

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aasmund A. Fretland

Oslo University Hospital

Phone: 004723070100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place