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

Right-sided Colon Cancer Clinical Trial

— RACOMERC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834011
• Other study ID #: RACOMERC 01/2021
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2021
• Source: University of Palermo
• Contact: Antonino Agrusa, Professor
• Phone: +390916552612
• Email: antonino.agrusa[@]unipa.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Right-sided Colon Cancer

Intervention

Procedure:
• Laparoscopic right colonic resection with Complete Mesocolic Excision (CME)

Radiation:
• 3D CT angiography

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo	Palermo	Italy - Sicily

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Açar HI, Cömert A, Avsar A, Çelik S, Kuzu MA. Dynamic article: surgical anatomical planes for complete mesocolic excision and applied vascular anatomy of the right colon. Dis Colon Rectum. 2014 Oct;57(10):1169-75. doi: 10.1097/DCR.0000000000000128. — View Citation

Mari FS, Nigri G, Pancaldi A, De Cecco CN, Gasparrini M, Dall'Oglio A, Pindozzi F, Laghi A, Brescia A. Role of CT angiography with three-dimensional reconstruction of mesenteric vessels in laparoscopic colorectal resections: a randomized controlled trial. Surg Endosc. 2013 Jun;27(6):2058-67. doi: 10.1007/s00464-012-2710-9. Epub 2013 Jan 5. — View Citation

Mike M, Kano N. Laparoscopic surgery for colon cancer: a review of the fascial composition of the abdominal cavity. Surg Today. 2015 Feb;45(2):129-39. doi: 10.1007/s00595-014-0857-9. Epub 2014 Feb 11. Review. — View Citation

Miyazawa M, Kawai M, Hirono S, Okada K, Shimizu A, Kitahata Y, Yamaue H. Preoperative evaluation of the confluent drainage veins to the gastrocolic trunk of Henle: understanding the surgical vascular anatomy during pancreaticoduodenectomy. J Hepatobiliary Pancreat Sci. 2015 May;22(5):386-91. doi: 10.1002/jhbp.205. Epub 2015 Jan 7. — View Citation

Murono K, Kawai K, Ishihara S, Otani K, Yasuda K, Nishikawa T, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Yamaguchi H, Watanabe T. Evaluation of the vascular anatomy of the right-sided colon using three-dimensional computed tomography angiography: a single-center study of 536 patients and a review of the literature. Int J Colorectal Dis. 2016 Sep;31(9):1633-8. doi: 10.1007/s00384-016-2627-1. Epub 2016 Jul 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perioperative outcomes: intraoperative complications	complication occurred during surgery	intraoperative time
Secondary	Perioperative outcomes: postoperative complications	complication occurred in postoperative period	up to 30 days postoperative
Secondary	Perioperative outcomes: mean operative time	operative time	intraoperative time
Secondary	perioperative outcomes: rate of conversion	rate of conversion from laparoscopy to open surgery	intraoperative time