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

NCT04834011 | Unknown

• 1 other identifier: RACOMERC 01/2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Right-sided Colon Cancer

Keywords

Right colon cancer; complete mesocolic excision; CT abdominal scan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Perioperative outcomes: intraoperative complications

  intraoperative time

• Perioperative outcomes: postoperative complications

  up to 30 days postoperative

• Perioperative outcomes: mean operative time

  intraoperative time

• perioperative outcomes: rate of conversion

  intraoperative time

Interventions

Laparoscopic right colonic resection with Complete Mesocolic Excision (CME) PROCEDURE

3D CT angiography RADIATION

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with endoscopic diagnosis of right-sided colon cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo

Palermo, Italy - Sicily, 90127, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 24515451 BACKGROUND

• 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.

  PMID: 23292563 BACKGROUND

• Acar HI, Comert A, Avsar A, Celik 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.

  PMID: 25203372 BACKGROUND

• 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.

  PMID: 27461539 BACKGROUND

• 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.

  PMID: 25565654 BACKGROUND

Study Officials

• Antonino Agrusa, Professor

  University of Palermo - Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonino Agrusa, Professor

CONTACT

+390916552612; antonino.agrusa@unipa.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 6, 2021
• Study Start: January 1, 2013
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2023
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

IT (1)