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Completed

NCT Number: NCT05475041

Perioperative Outcomes of Simultaneous Colorectal and Liver Resections

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.

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Key information

Conditions

Colorectal Cancer Metastatic Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardy, 25124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Major liver resection

Procedure

Major liver resection (3 or more contiguous segments)

Technically major liver resection

Procedure

Minor liver resection (<3 contiguous segments) in the posterosuperior segments (segment 1,4a,7,8)

Primary outcomes

  1. Major complications

    Time frame: 30 days postoperatively

    Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure

Secondary outcomes

  1. Overall complications

    Time frame: 30 days postoperatively

    Overall complications related to the surgical procedure

  2. Length of hospital stay

    Time frame: 30 days postoperatively

    The length of hospital stay for the surgical procedure

  3. R0 resection margin

    Time frame: 30 days postoperatively

    Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.

  4. Intraoperative blood loss

    Time frame: During the surgical procedure

    Intraoperative blood loss in milliliters

  5. Operative time

    Time frame: During the surgical procedure

    Operative time in minutes

  6. Conversion to open surgery

    Time frame: During the surgical procedure

    Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group

  7. Mortality

    Time frame: 90 days postoperatively

    Postoperative mortality

  8. Red blood cell transfusion

    Time frame: During the surgical procedure

    Intraoperative red blood cell transfusion

  9. Intraoperative incidents

    Time frame: During the surgical procedure

    Intraoperative unfavourable incidents

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Collaborators

  • Antoine Béclère Hospital Paris
  • Catholic University of the Sacred Heart
  • Clinica Universidad de Navarra, Universidad de Navarra
  • Groeninge Hospital Kortrijk
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS San Raffaele
  • 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
  • Universita di Verona
  • University Hospital Padua
  • University Hospital Southampton NHS Foundation Trust
  • University Hospital of Girona Dr. Josep Trueta
  • University of Amsterdam

Registry information

Official study title

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

Acronym: SIMULT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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