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

Phase 3

Completed

• Conditions: Colorectal Laparoscopic Resection

• Registration Number: NCT01540448
• Lead Sponsor: University of Roma La Sapienza

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 available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-01
• Status Verified: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Performance (operative time)	within the first 4 hours	The consequences on the surgical performance of preoperative knowledge of the mesenteric vascular anatomy assessed by the evaluation of the operative time

Secondary Outcome Measures

Name	Time	Method
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	Iatrogenic vascular or visceral injuries related to difficult identification of right anatomy
intraoperative bleeding	within the first 4 hours	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	within the first 15 postoperative days
lymph nodes harvesting	within first 4 hours	number harvested of lymph nodes
Anatomical variations of mesenteric vessels	Within 24 hours before surgical procedure	anatomical variations of mesenteric vessels detected by peroperative CT scan

Trial Locations

Locations (1)

Azienda Ospedaliera Sant'Andrea; 🇮🇹 Rome, Italy