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

Colorectal Laparoscopic Resection Clinical Trial

— 3DCT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540448
• Other study ID #: DS-005
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2012
• Last updated: February 22, 2012
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Laparoscopic Resection

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Sant'Andrea	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Performance (operative time)	The consequences on the surgical performance of preoperative knowledge of the mesenteric vascular anatomy assessed by the evaluation of the operative time	within the first 4 hours	No
Secondary	complex identification of mesenteric vessels performing laparoscopic colorectal resection		within the first 4 hours	No
Secondary	Iatrogenic vascular or visceral injuries	Iatrogenic vascular or visceral injuries related to difficult identification of right anatomy	within the first 10 postoperative days	No
Secondary	intraoperative bleeding	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.	within the first 4 hours	No
Secondary	Postoperative complications		within the first 15 postoperative days	No
Secondary	lymph nodes harvesting	number harvested of lymph nodes	within first 4 hours	No
Secondary	Anatomical variations of mesenteric vessels	anatomical variations of mesenteric vessels detected by peroperative CT scan	Within 24 hours before surgical procedure	No