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

February 22, 2012 updated by: Francesco Saverio Mari, University of Roma La Sapienza
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical Performance (operative time)
Time Frame: 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
within the first 4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
complex identification of mesenteric vessels performing laparoscopic colorectal resection
Time Frame: within the first 4 hours
within the first 4 hours
Iatrogenic vascular or visceral injuries
Time Frame: within the first 10 postoperative days
Iatrogenic vascular or visceral injuries related to difficult identification of right anatomy
within the first 10 postoperative days
intraoperative bleeding
Time Frame: 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.
within the first 4 hours
Postoperative complications
Time Frame: within the first 15 postoperative days
within the first 15 postoperative days
lymph nodes harvesting
Time Frame: within first 4 hours
number harvested of lymph nodes
within first 4 hours
Anatomical variations of mesenteric vessels
Time Frame: Within 24 hours before surgical procedure
anatomical variations of mesenteric vessels detected by peroperative CT scan
Within 24 hours before surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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