IVACOR Trial: Minimally invasive LIVer And simultaneous COlorectal Resectio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 16

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 <= 50% for
serious complications

*In case of neoadjuvant chemotherapy, time interval between last chemotherapy
cycle and (first) surgery should be 4-6 weeks.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome will be time to functional recovery. Time to functional<br /><br>recovery in the staged group will be determined by adding up the time to<br /><br>functional recovery of the two procedures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will include R0 resection margin, total length of hospital<br /><br>stay, intraoperative blood loss, operation time, morbidity, postoperative bile<br /><br>leakage, postoperative anastomotic leakage, conversion to open surgery,<br /><br>readmission rate, quality of life, reasons for delay of discharge after<br /><br>functional recovery, hospital and societal costs over one year, three and<br /><br>five-year recurrence free and overall survival, physical activity pre- and<br /><br>postoperative.</p><br>