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

• Conditions: Right-sided Colon Cancer

• Registration Number: NCT04834011
• Lead Sponsor: University of Palermo

Brief 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

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Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2020-12-31
• Study First Submitted: 2021-03-22
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-02
• Last Update Submitted: 2021-04-02
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Evaluation of preoperative CT scan features during enrollment of patients.	Evaluation of preoperative CT scan features during enrollment of patients.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo; 🇮🇹 Palermo, Italy - Sicily, Italy