Perioperative Outcomes of Simultaneous Colorectal and Liver Resections
SIMULT
Simultaneous Resection of Colorectal Cancer and Synchronous Liver Metastases: What Determines the Risk of Unfavorable Outcomes? A Retrospective International Multicenter Study
1 other identifier
observational
766
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2022
CompletedFirst Submitted
Initial submission to the registry
July 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedJuly 26, 2022
July 1, 2022
10 days
July 22, 2022
July 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major complications
Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure
30 days postoperatively
Secondary Outcomes (9)
Overall complications
30 days postoperatively
Length of hospital stay
30 days postoperatively
R0 resection margin
30 days postoperatively
Intraoperative blood loss
During the surgical procedure
Operative time
During the surgical procedure
- +4 more secondary outcomes
Study Arms (3)
Minor liver resection
Minor liver resection (\<3 contiguous segments) in the anterolateral segments
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 (3 or more contiguous segments)
Interventions
Major liver resection (3 or more contiguous segments)
Minor liver resection (\<3 contiguous segments) in the posterosuperior segments (segment 1,4a,7,8)
Eligibility Criteria
Patients that underwent an elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases in 17 hepato-biliary referall centers in the time period from January 2004 to December 2019
You may qualify if:
- Elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Poliambulanza Istituto Ospedalierolead
- University of Amsterdamcollaborator
- Universita di Veronacollaborator
- Umberto I Mauriziano Hospital Turincollaborator
- IRCCS Azienda Ospedaliero-Universitaria di Bolognacollaborator
- IRCCS San Raffaelecollaborator
- University Hospital Paduacollaborator
- Riuniti Hospital Polytechnic University of Marche Anconacollaborator
- Clinica Universidad de Navarra Pamplonacollaborator
- Groeninge Hospital Kortrijkcollaborator
- Oslo University Hospital and Institute of Medicinecollaborator
- The Queen Elizabeth Hospitalcollaborator
- Antoine Béclère Hospital Pariscollaborator
- Moscow Clinical Research Centrecollaborator
- University Hospital of Girona Dr. Josep Truetacollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
- Università Cattolica del Sacro Cuore-IRCCS Romecollaborator
Study Sites (1)
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, 25124, Italy
Related Publications (1)
Sijberden JP, Zimmitti G, Conci S, Russolillo N, Masetti M, Cipriani F, Lanari J, Gorgec B, Benedetti Cacciaguerra A, Rotellar F, D'Hondt M, Edwin B, Sutcliffe RP, Dagher I, Efanov M, Lopez-Ben S, Primrose JN, Giuliante F, Spinelli A, Chand M, Alvarez S, Langella S, Nicosia S, Ruzzenente A, Vivarelli M, Cillo U, Aldrighetti L, Jovine E, Ferrero A, Guglielmi A, Besselink MG, Abu Hilal M. Simultaneous resection of colorectal cancer and synchronous liver metastases: what determines the risk of unfavorable outcomes? An international multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):244-254. doi: 10.1097/JS9.0000000000000068.
PMID: 37093069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2022
First Posted
July 26, 2022
Study Start
June 30, 2022
Primary Completion
July 10, 2022
Study Completion
July 22, 2022
Last Updated
July 26, 2022
Record last verified: 2022-07