Large bowel cancer with liver metastases
Conditions
Interventions
MI combined colorectal and liver resection
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • >= 18 years • Diagnosed with primary CRC with resectable synchronous CRLMs (with or without neoadjuvant chemotherapy) * • Elective indication for MI combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to 3 segments with a maximum of 2 separate liver resections. The MI two-staged approach includes both the conventional strategy (first resection of primary colorectal tumor followed by liver resection for CRLMs) and liver-first strategy (first CRLMs resection followed by resection of colorectal primary tumor). Patients undergoing bilobar resections are eligible (if 3 or fewer segments are resected) • BMI between and including 18-35 • Patients with American Society of Anesthesiologists (ASA) physical status I-III and the American College of Surgeons national surgical quality improvement project (ACS NSQIP) universal surgical risk score of
Exclusion criteria
Exclusion criteria: • Inability to give (written) informed consent. • Patients requiring a planned temporarily or permanent stoma after colorectal resection (all colectomies, including high anterior resection). Patients who will receive an unplanned stoma intraoperatively, will be analysed according to their initial treatment assignment. • Patients requiring multivisceral colorectal resection (all colectomies, including high anterior resection). • Indication for MI combined or staged low anterior resection, total mesorectal excision or abdominoperineal resection and liver resection of four or more segments (i.e., hemihepatectomy or more extensive resections). • Patients with peritoneal metastases. • Patients with ASA physical status IV-V and ACS NSQIP surgical risk score of > 50% for serious complications. • Repeat open hepatectomy • Surgical history of colorectal- or liver resection for neoplastic disease • Surgical history of major or complicated open abdominal surgery • Indication for concurrent thermal ablation • Medical history of thermal ablation of liver for malignancy • Unresectable extrahepatic metastases • Pre-operatively reconstruction of vessels/bile ducts is deemed necessary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be time to functional recovery. Time to functional recovery in the staged group will be determined by adding up the time to functional recovery of the two procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include R0 resection margin, total length of hospital stay, intraoperative blood loss, operation time, morbidity, postoperative bile leakage, postoperative anastomotic leakage, conversion to open surgery, readmission rate, quality of life, reasons for delay of discharge after functional recovery, hospital and societal costs over one year, three and five-year recurrence free and overall survival, physical activity pre- and postoperative. | — |
Countries
Netherlands
Outcome results
None listed