Role of CT Angiography With Three-dimensional Reconstruction of Mesenteric Vessels in Planning and Performing of Laparoscopic Colorectal Resections (3DCT)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Francesco Saverio Mari, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT01540448

First received: February 14, 2012

Last updated: February 22, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 14, 2012
Last Updated Date	February 22, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 22, 2012)	Surgical Performance (operative time) [ Time Frame: within the first 4 hours ] [ Designated as safety issue: No ] The consequences on the surgical performance of preoperative knowledge of the mesenteric vascular anatomy assessed by the evaluation of the operative time
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01540448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 22, 2012)	complex identification of mesenteric vessels performing laparoscopic colorectal resection [ Time Frame: within the first 4 hours ] [ Designated as safety issue: No ] Iatrogenic vascular or visceral injuries [ Time Frame: within the first 10 postoperative days ] [ Designated as safety issue: No ] Iatrogenic vascular or visceral injuries related to difficult identification of right anatomy intraoperative bleeding [ Time Frame: within the first 4 hours ] [ Designated as safety issue: No ] intraoperative bleeding related to dissection for mesenteric vessels quest. Blood loss of less than 20 mL was considered mild; between 20 and 100 mL, moderate; and more than 100 mL, severe. Postoperative complications [ Time Frame: within the first 15 postoperative days ] [ Designated as safety issue: No ] lymph nodes harvesting [ Time Frame: within first 4 hours ] [ Designated as safety issue: No ] number harvested of lymph nodes Anatomical variations of mesenteric vessels [ Time Frame: Within 24 hours before surgical procedure ] [ Designated as safety issue: No ] anatomical variations of mesenteric vessels detected by peroperative CT scan
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Role of CT Angiography With Three-dimensional Reconstruction of Mesenteric Vessels in Planning and Performing of Laparoscopic Colorectal Resections
Official Title ^ICMJE	Not Provided
Brief Summary	The aim of this study is to evaluate if the prior knowledge of the individual mesenteric vascular anatomy of patients represents an advantage in performing laparoscopic colorectal resections. The investigators want demonstrate that the three-dimensional reconstruction of colonic vascular anatomy, acquired with a CT angiography, may lead to a more effective and less extensive dissection and to a fewer intraoperative and postoperative complications.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Colorectal Laparoscopic Resection
Intervention ^ICMJE	Procedure: Laparoscopic Right Hemicolectomy We perform the Right Hemicolectomy (RH) with a 3 trocars technique. The procedure starts with the identification and sectioning of the ileocolic vessels at their origin. Next, is possible to divide the mesentery towards the terminal ileum, which was sectioned by laparoscopic linear stapler. The procedure continues with the incision of the Houston's ligament and the retroperitoneal dissection of the cecum and ascending colon up to the right flexure by pulling the terminal ileum upwards. During this maneuvers and eventually after the incision of the hepato-duodenocolic ligament, is possible to identify and cut the right colic vessels and, if necessary, the middle colic vessels and the Henle's venous branch.With the right colon and proximal transverse completely mobilized, it is possible to section the colon with a linear laparoscopic stapler and to create a 4-6 cm service incision to remove the specimen and perform an extracorporeal ileo-colic isoperistaltic mechanical anastomosis. Procedure: Laparoscopic Left Hemicolectomy We routinely perform the Left Hemicolectomy (LH) with a 3 trocars technique eventually placing the 4th trocar in the left flank if needed. The procedure started with the division of the gastro-spleno-colic ligament and the subsequent mobilization of the left colic flexure. Then is possible to identify and section the inferior mesenteric vessels. Performing LH the Inferior Mesenteric Artery (IMA) is usually tied immediately below the origin of the Left Colic Artery (LCA) while in presence of benign disease, to preserve the IMA, the dissection is performed along the course of the vessel, sectioning progressively the sigmoid arterial branches close to the colonic wall. When left colon is completely mobilized from the retroperitoneum along the avascular plane between the mesocolon and perirenal fat is possible to section the distal colon and finally perform a termino-terminal mechanical anastomosis. Procedure: Anterior Rectal Resection We routinely perform the Anterior Rectal Resection (ARR) with a 3 trocars technique eventually placing the 4th trocar in the left flank if needed. The procedure started with the division of the gastro-spleno-colic ligament and the subsequent mobilization of the left colic flexure. Then is possible to identify and section the inferior mesenteric vessels. Performing ARR the Inferior Mesenteric Artery (IMA) is usually tied at origin but in particular cases it can be tied immediately below the origin of the Left Colic Artery (LCA). When left colon and is completely mobilized from the retroperitoneum along the avascular plane between the mesocolon and perirenal fat is possible to perform a partial or total mesorectal excision. Usually a termino-terminal mechanical anastomosis is performed at the end of the procedure.
Study Arm (s)	Active Comparator: No-3DCT All patients were subjected to a CT scan with 3D mesenteric angiography but the surgeon was able to view the 3D reconstruction only after surgery. Interventions: Procedure: Laparoscopic Right Hemicolectomy Procedure: Laparoscopic Left Hemicolectomy Procedure: Anterior Rectal Resection Experimental: 3DCT All patients were subjected to a CT scan with 3D mesenteric angiography and the surgeon was able to view 3D reconstruction before and during laparoscopic colorectal resection. Interventions: Procedure: Laparoscopic Right Hemicolectomy Procedure: Laparoscopic Left Hemicolectomy Procedure: Anterior Rectal Resection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	February 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: need of colorectal resection absence of preoperative CT scan Exclusion Criteria: contraindications to laparoscopy ASA IV BMI > 40 Kg/m2 need of non standard colonic resection
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01540448
Other Study ID Numbers ^ICMJE	DS-005
Has Data Monitoring Committee	Not Provided
Responsible Party	Francesco Saverio Mari, University of Roma La Sapienza
Study Sponsor ^ICMJE	University of Roma La Sapienza
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Roma La Sapienza
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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