Perioperative Outcomes of Simultaneous Colorectal and Liver Resections

Colorectal Cancer Metastatic Clinical Trial

— SIMULT  

Official title:

Simultaneous Resection of Colorectal Cancer and Synchronous Liver Metastases: What Determines the Risk of Unfavorable Outcomes? A Retrospective International Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475041
• Other study ID #: NP5467
• Status: Completed
• Start date: June 30, 2022
• Est. completion date: July 22, 2022

Study information

• Verified date: July 2022
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 766
• Est. completion date: July 22, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Major liver resection
Major liver resection (3 or more contiguous segments)
• Technically major liver resection
Minor liver resection (<3 contiguous segments) in the posterosuperior segments (segment 1,4a,7,8)

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia	Lombardy

Sponsors (17)

Lead Sponsor

Collaborator

Fondazione Poliambulanza Istituto Ospedaliero

Amsterdam UMC location University of Amsterdam, Antoine Béclère Hospital Paris, Clinica Universidad de Navarra Pamplona, Groeninge Hospital Kortrijk, Hospital Doctor Josep Trueta de Girona, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS San Raffaele Hospital Milan, Moscow Clinical Research Centre, Oslo University Hospital and Institute of Medicine, Riuniti Hospital Polytechnic University of Marche Ancona, The Queen Elizabeth Hospital, Umberto I Mauriziano Hospital Turin, Università Cattolica del Sacro Cuore-IRCCS Rome, Universita di Verona, University Hospital Padua, University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complications	Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure	30 days postoperatively
Secondary	Overall complications	Overall complications related to the surgical procedure	30 days postoperatively
Secondary	Length of hospital stay	The length of hospital stay for the surgical procedure	30 days postoperatively
Secondary	R0 resection margin	Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.	30 days postoperatively
Secondary	Intraoperative blood loss	Intraoperative blood loss in milliliters	During the surgical procedure
Secondary	Operative time	Operative time in minutes	During the surgical procedure
Secondary	Conversion to open surgery	Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group	During the surgical procedure
Secondary	Mortality	Postoperative mortality	90 days postoperatively
Secondary	Red blood cell transfusion	Intraoperative red blood cell transfusion	During the surgical procedure
Secondary	Intraoperative incidents	Intraoperative unfavourable incidents	During the surgical procedure