Perioperative Outcomes of Simultaneous Colorectal and Liver Resections

Completed

• Conditions: Surgical Procedure, Unspecified; Colorectal Cancer Metastatic
• Interventions: Procedure: Technically major liver resection; Procedure: Major liver resection

• Registration Number: NCT05475041
• Lead Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Brief Summary

The use of a simultaneous resection in patients with synchronous colorectal liver metastases has increased over the past decades. However, it remains unclear when a simultaneous resection is beneficial and when it should be avoided. The objective of this retrospective study is therefore to compare the outcomes of a simultaneous resection for synchronous colorectal liver metastases in different settings, and to assess which factors are independently associated with unfavorable outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Status Verified: 2022-07
• Primary Completion: 2022-07-10
• Study Completion: 2022-07-22
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 766

Inclusion Criteria

• Elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases

Exclusion Criteria

• (Partially) robotic-assisted or thoracoscopic procedures
• First stage of associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)
• Patients that underwent major concurrent procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Technically major liver resection	Technically major liver resection	Minor liver resection (\<3 contiguous segments) in the posterosuperior segments (Segment 1,4a,7,8)
Major liver resection	Major liver resection	Major liver resection (3 or more contiguous segments)

Primary Outcome Measures

Name	Time	Method
Major complications	30 days postoperatively	Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure

Secondary Outcome Measures

Name	Time	Method
Overall complications	30 days postoperatively	Overall complications related to the surgical procedure
Conversion to open surgery	During the surgical procedure	Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group
Intraoperative incidents	During the surgical procedure	Intraoperative unfavourable incidents
Intraoperative blood loss	During the surgical procedure	Intraoperative blood loss in milliliters
Length of hospital stay	30 days postoperatively	The length of hospital stay for the surgical procedure
Operative time	During the surgical procedure	Operative time in minutes
R0 resection margin	30 days postoperatively	Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Red blood cell transfusion	During the surgical procedure	Intraoperative red blood cell transfusion
Mortality	90 days postoperatively	Postoperative mortality

Trial Locations

Locations (1)

Fondazione Poliambulanza Istituto Ospedaliero; 🇮🇹 Brescia, Lombardy, Italy