SIMULT: Perioperative Outcomes of Simultaneous Colorectal and Liver Resections

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero (Other)

Overall Status

Completed

CT.gov ID

NCT05475041

Collaborator

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

766

Enrollment

Location

Actual Duration (Days)

1059.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Metastatic Surgical Procedure, Unspecified	Procedure: Major liver resection Procedure: Technically major liver resection

Study Design

Study Type:

Observational

Actual Enrollment :

766 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2022

Actual Primary Completion Date :

Jul 10, 2022

Actual Study Completion Date :

Jul 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
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)	Procedure: 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)	Procedure: Major liver resection Major liver resection (3 or more contiguous segments)

Arm

Intervention/Treatment

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)

Procedure: 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)

Procedure: Major liver resection

Major liver resection (3 or more contiguous segments)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Overall complications [30 days postoperatively]
Overall complications related to the surgical procedure
Length of hospital stay [30 days postoperatively]
The length of hospital stay for the surgical procedure
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.
Intraoperative blood loss [During the surgical procedure]
Intraoperative blood loss in milliliters
Operative time [During the surgical procedure]
Operative time in minutes
Conversion to open surgery [During the surgical procedure]
Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group
Mortality [90 days postoperatively]
Postoperative mortality
Red blood cell transfusion [During the surgical procedure]
Intraoperative red blood cell transfusion
Intraoperative incidents [During the surgical procedure]
Intraoperative unfavourable incidents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Poliambulanza Istituto Ospedaliero	Brescia	Lombardy	Italy	25124

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Poliambulanza Istituto Ospedaliero

ClinicalTrials.gov Identifier:

NCT05475041

Other Study ID Numbers:

NP5467

First Posted:

Jul 26, 2022

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero

colorectal cancer

synchronous colorectal liver metastases

simultaneous resection

postoperative outcomes

Additional relevant MeSH terms:

Colorectal Neoplasms

Liver Extracts

Study Results

No Results Posted as of Jul 26, 2022