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

NCT01540448 | Completed Phase 3

• 1 other identifier: DS-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Laparoscopic Resection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• complex identification of mesenteric vessels performing laparoscopic colorectal resection

  within the first 4 hours

• Iatrogenic vascular or visceral injuries

  within the first 10 postoperative days

• intraoperative bleeding

  within the first 4 hours

• Postoperative complications

  within the first 15 postoperative days

• lymph nodes harvesting

  within first 4 hours

Study Arms (2)

No-3DCT

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic Right Hemicolectomy; Procedure: Laparoscopic Left Hemicolectomy; Procedure: Anterior Rectal Resection

3DCT

EXPERIMENTAL

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.

Procedure: Laparoscopic Right Hemicolectomy; Procedure: Laparoscopic Left Hemicolectomy; Procedure: Anterior Rectal Resection

Interventions

Laparoscopic Right Hemicolectomy PROCEDURE

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.

3DCT; No-3DCT

Laparoscopic Left Hemicolectomy PROCEDURE

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.

3DCT; No-3DCT

Anterior Rectal Resection PROCEDURE

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.

3DCT; No-3DCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• need of colorectal resection
• absence of preoperative CT scan

You may not qualify if:

• contraindications to laparoscopy
• ASA IV
• BMI \> 40 Kg/m2
• need of non standard colonic resection

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Azienda Ospedaliera Sant'Andrea

Rome, Italy, 00189, Italy

Location

Related Publications (1)

• 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 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 28, 2012
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

IT (1)