Radiologic Assessment in Complete Mesocolic Excision for Right Colon Cancer (RACOMERC) (RACOMERC)

April 2, 2021 updated by: Prof. Antonino Agrusa, University of Palermo

Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) in Right-sided Colon Cancer: Surgical and Radiological Assessment. A Prospective Observational Study (RACOMERC)

Colorectal surgery has made progressive advances in recent years related on one hand to the implementation of diagnostic methods that allow an early diagnosis of tumors and on the other hand to the development of therapeutic options based on laparoscopic surgery. In particular, multicenter clinical trials have shown that the laparoscopic approach to colorectal cancer had a comparable or even better outcomes in terms of perioperative complications and functional recovery of patients than traditional surgery. Complete Mesocolic Excision (CME) in right colonic resections is a surgical approach, of greater technical complexity, that appears to improve the oncological outcomes of these patients at the cost of an increased rate of complications. The highest rate of complications reported in the literature in patients undergoing CME was related to intraoperative bleeding due to the central vascular dissection that is performed. CT technological advances have made possible to perform CT angiography with multiplanar and three-dimensional reconstructions with the possibility of obtaining a detailed preoperative map of the vascular anatomy of these patients. CT scan was acquired immediately before contrast material injection and during arterial and venous phase. Arterial phase was obtained using the bolus tracking technique with an automated scan-triggering software. Image analysis was performed using multiplanar reformations (MPR), maximum intensity projection (MIP) and 3D volume rendering (VR) technique. The purpose of the CT was to identify three different parameters necessary for proper performance of CME and CVL and to compare preoperative observations with intraoperative evidence. All surgeries were performed by teams experienced in laparoscopic colorectal surgery. The investigators evaluated:- Fascia of Fredet; vascular structures; lymph nodes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

x

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Italy - Sicily
      • Palermo, Italy - Sicily, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with endoscopic diagnosis of right-sided colon cancer

Description

Inclusion Criteria:

  • patients with diagnosis of right-sided colon cancer
  • patients underwent to CT angiography
  • laparoscopic right hemicolectomy with CME and CVL.

Exclusion Criteria:

  • metastatic disease
  • palliative treatment
  • impossibility to perform CT angiography
  • patients underwent to a traditional colonic resection with D2 lymphadenectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative radiologic assessment of patients with diagnosis of right-sided colon cancer. The investigators evaluated: fascia of Fredet; vascular structures (ileocolic vessels; right colic artery, middle colic artery, trunk of Henle); lymph nodes.
Time Frame: Evaluation of preoperative CT scan features during enrollment of patients.
Evaluation of preoperative CT scan features during enrollment of patients.
Evaluation of preoperative CT scan features during enrollment of patients.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative outcomes: intraoperative complications
Time Frame: intraoperative time
complication occurred during surgery
intraoperative time
Perioperative outcomes: postoperative complications
Time Frame: up to 30 days postoperative
complication occurred in postoperative period
up to 30 days postoperative
Perioperative outcomes: mean operative time
Time Frame: intraoperative time
operative time
intraoperative time
perioperative outcomes: rate of conversion
Time Frame: intraoperative time
rate of conversion from laparoscopy to open surgery
intraoperative time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Antonino Agrusa, Professor, University of Palermo - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACOMERC 01/2021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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