Clinical trial NCT05475041: Perioperative Outcomes of Simultaneous Colorectal and Liver Resections
Official title: Simultaneous Resection of Colorectal Cancer and Synchronous Liver Metastases: What Determines the Risk of Unfavorable Outcomes? A Retrospective International Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Metastatic
Surgical Procedure, Unspecified
Keywords: colorectal cancer
synchronous colorectal liver metastases
simultaneous resection
postoperative outcomes
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC location University of Amsterdam
name: Universita di Verona
name: Umberto I Mauriziano Hospital Turin
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: IRCCS San Raffaele
name: University Hospital Padua
name: Riuniti Hospital Polytechnic University of Marche Ancona
name: Clinica Universidad de Navarra Pamplona
name: Groeninge Hospital Kortrijk
name: Oslo University Hospital and Institute of Medicine
name: The Queen Elizabeth Hospital
name: Antoine Béclère Hospital Paris
name: Moscow Clinical Research Centre
name: Hospital Doctor Josep Trueta de Girona
name: University Hospital Southampton NHS Foundation Trust
name: Università Cattolica del Sacro Cuore-IRCCS Rome
First posted: 2022-07-26
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major complications
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Overall complications
timeFrame: 30 days postoperatively
measure: Length of hospital stay
timeFrame: 30 days postoperatively
measure: R0 resection margin
timeFrame: 30 days postoperatively
measure: Intraoperative blood loss
timeFrame: During the surgical procedure
measure: Operative time
timeFrame: During the surgical procedure
measure: Conversion to open surgery
timeFrame: During the surgical procedure
measure: Mortality
timeFrame: 90 days postoperatively
measure: Red blood cell transfusion
timeFrame: During the surgical procedure
measure: Intraoperative incidents
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
state: Lombardy
Study officials:
References: