An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.
American Society of Anesthesiologists(ASA) grade I-III.
Right colon cancer (*The right-sided location of the cancer is defined as the location from the caecum up to the proximal third of the transverse colon), preoperative assessment of tumor stage T2-T4a, any N or T any N+ according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015); no distant metastasis.
Informed consent
Age > 85 years old.
T1, N0
T4b, any N
BMI > 30.
Parallel
Conventional Right hemicolectomy (Non-CME)
Procedure/SurgeryTransecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted.
Right hemicolectomy with CME+CVL
Procedure/SurgerySeparation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly: * The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery * The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as well as The Right Gastroepiploic Vessels at their origin from the gastrocolic trunk of Henle (GCTH) and the gastroduodenal artery. The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance.
Disease-free survival at 3 years
The length of time after surgery without any signs or symptoms of local or distant recurrence.
Safety-Operative time.
Total time from incision to skin closure expressed in minutes.
Safety-Intraoperative blood loss.
Defined by the volume drained in cm2 into aspiration systems and weight of gauzes, calculated, subtracting the weight of the dry gauzes and volume of saline solution used for irrigation.
Safety-Intraoperative blood transfusion.
Defined as the number of red blood cells, platelets, or plasma units transfused during the intraoperative time.
Safety- Intraoperative Complications.
Defined as any deviation from the ideal intraoperative course occurring during the operative time, Using the Classification of Intraoperative Complications(CLASSIC).
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University of Turin, Italy
Lead sponsor
Federico II University
Collaborator
Agnelli Hospital, Italy
Collaborator
Ospedale della Misericordia
Collaborator
Candiolo Cancer Institute - IRCCS
Collaborator
Maggiore Bellaria Hospital, Bologna
Collaborator
Università degli Studi di Ferrara
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator
Ospedale Policlinico San Martino
Collaborator
University of Rome Tor Vergata
Collaborator
S. Andrea Hospital
Collaborator
European Institute of Oncology
Collaborator
