Colorectal Laparoscopic ResectionPhase 33DCTNCT01540448

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

A Phase 3 study testing Laparoscopic Right Hemicolectomy, Laparoscopic Left Hemicolectomy and Anterior Rectal Resection in people with Colorectal Laparoscopic Resection, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Laparoscopic Resection
What is being tested?: Laparoscopic Right Hemicolectomy, Laparoscopic Left Hemicolectomy and Anterior Rectal Resection
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteItaly
Study dates: Jan 2010to Feb 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

need of colorectal resection
absence of preoperative CT scan

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00189

Other trials in Italy

About this study

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
Being tested: Laparoscopic Right Hemicolectomy, Laparoscopic Left Hemicolectomy, Anterior Rectal Resection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic Right HemicolectomyProcedure or surgery
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 HemicolectomyProcedure or surgery
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 ResectionProcedure or surgery
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 groups in NCT01540448
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Laparoscopic Right Hemicolectomy; Procedure: Laparoscopic Left Hemicolectomy; Procedure: Anterior Rectal Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: within the first 4 hours

Secondary outcomes (6)

complex identification of mesenteric vessels performing laparoscopic colorectal resection
Measured: within the first 4 hours
Iatrogenic vascular or visceral injuries
Iatrogenic vascular or visceral injuries related to difficult identification of right anatomy
Measured: within the first 10 postoperative days
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.
Measured: within the first 4 hours
Postoperative complications
Measured: within the first 15 postoperative days
lymph nodes harvesting
number harvested of lymph nodes
Measured: within first 4 hours
Anatomical variations of mesenteric vessels
anatomical variations of mesenteric vessels detected by peroperative CT scan
Measured: Within 24 hours before surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Feb 2012

First posted28 Feb 2012 (estimated)
Study startJan 2010
Primary completionJan 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal Laparoscopic ResectionStudies of the same condition, open and under way.
More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01540448
Sponsor's protocol ID: DS-005
Acronym: 3DCT
Status last verified: Feb 2012
First submitted: 14 Feb 2012
Last updated: 28 Feb 2012
Results posted: No

Publications

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.
PubMed 23292563

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of CT Angiography With Three-dimensional Reconstruction of Mesenteric Vessels in Planning and Performing of Laparoscopic Colorectal Resections
ClinicalTrials.gov ID: NCT01540448
Acronym / sponsor ID: 3DCT / DS-005
Conditions: Colorectal Laparoscopic Resection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of Roma La SapienzaUniversity, hospital or other
Study start: Jan 2010
Primary completion: Jan 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 28 Feb 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
No-3DCT	Active comparator	Procedure: Laparoscopic Right Hemicolectomy, Procedure: Laparoscopic Left Hemicolectomy, Procedure: Anterior Rectal ResectionAll patients were subjected to a CT scan with 3D mesenteric angiography but the surgeon was able to view the 3D reconstruction only after surgery.
3DCT	Experimental	Procedure: Laparoscopic Right Hemicolectomy, Procedure: Laparoscopic Left Hemicolectomy, Procedure: Anterior Rectal ResectionAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

need of colorectal resection
absence of preoperative CT scan

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laparoscopic Right HemicolectomyWe 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 or surgery	3DCT, No-3DCT
Laparoscopic Left HemicolectomyWe 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 or surgery	3DCT, No-3DCT
Anterior Rectal ResectionWe 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.	Procedure or surgery	3DCT, No-3DCT

Primary outcome

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

6 secondary outcomes

complex identification of mesenteric vessels performing laparoscopic colorectal resection
Time frame: within the first 4 hours
Iatrogenic vascular or visceral injuries
Time frame: within the first 10 postoperative days
intraoperative bleeding
Time frame: within the first 4 hours
Postoperative complications
Time frame: within the first 15 postoperative days
lymph nodes harvesting
Time frame: within first 4 hours
Anatomical variations of mesenteric vessels
Time frame: Within 24 hours before surgical procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
Derived from this study: PubMed 23292563Mari 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Performance (operative time) (time frame: within the first 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01540448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.