Clinical Trials Directory

Trials / Unknown

UnknownNCT04834011

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
University of Palermo · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

x

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic right colonic resection with Complete Mesocolic Excision (CME)
RADIATION3D CT angiography

Timeline

Start date
2013-01-01
Primary completion
2020-12-31
Completion
2023-12-31
First posted
2021-04-06
Last updated
2021-04-06

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04834011. Inclusion in this directory is not an endorsement.