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

NCT ID: NCT04834011

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2023-12-31

Brief Summary

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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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Conditions

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Right-sided Colon Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Laparoscopic right colonic resection with Complete Mesocolic Excision (CME)

Intervention Type PROCEDURE

3D CT angiography

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Prof. Antonino Agrusa

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonino Agrusa, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Palermo - Italy

Locations

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

Palermo, Italy - Sicily, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonino Agrusa, Professor

Role: CONTACT

+390916552612

Facility Contacts

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Antonino Agrusa, Professor

Role: primary

+390916552612

References

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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.

Reference Type BACKGROUND
PMID: 24515451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23292563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25203372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27461539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25565654 (View on PubMed)

Other Identifiers

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RACOMERC 01/2021

Identifier Type: -

Identifier Source: org_study_id

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