NCT03551470

Brief Summary

Up to 25% of newly diagnosed patients with colorectal cancer (CRC) have liver metastases (LM). Simultaneous colorectal and hepatic resection has been proven to be a safe and effective approach in dealing with metastatic colorectal cancer. The aim of this paper is to analyse perioperative and oncological outcomes of minimally invasive (laparoscopic and robotic) one-stage simultaneous resection of liver metastases and colorectal tumor in selected patients affected by colorectal cancer and synchronous liver metastases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

5.4 years

First QC Date

May 28, 2018

Last Update Submit

June 7, 2018

Conditions

Keywords

roboticlaparoscopyliver surgerycolorectal and synchronous liver metastasessimultaneous surgery

Outcome Measures

Primary Outcomes (5)

  • Short-term perioperative surgical outcomes

    Morbidity

    intra-operative - within 30 post-operative day

  • Mortality

    Intra-operative -within 30 post-operative day

  • Blood loss

    Measured in mL

    Intra-operative

  • Conversion rate

    Intra-operative

  • Operative time

    Measured in minutes

    Intra-operative

Study Arms (1)

Synchronous colorectal cancer and liver metastases

Robotic (Da Vinci) one-stage colorectal and liver resection

Procedure: Robotic one-stage colorectal and liver resection

Interventions

Synchronous colorectal cancer and liver metastases

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Selected patients affected by colorectal cancer with synchronous liver metastases

You may qualify if:

  • colorectal primary tumor with synchronous liver metastases
  • eligibility for minimally-invasive surgery

You may not qualify if:

  • unfitness for prolonged operative time
  • liver lesions \>5
  • pre-operative prediction of vascular resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michele De Rosa

Foligno, Perugia, 06034, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 11, 2018

Study Start

October 1, 2012

Primary Completion

March 1, 2018

Study Completion

October 1, 2020

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations