Learning Curve of Laparoscopic Colorectal ResectionsNCT01976000
Influence of CT 3D on the Learning Curve of Laparoscopic Colorectal Resection
An observational study of Learning Curve of Laparoscopic Colorectal Resections, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the well-known benefits and comparable oncological outcomes, it is still limited by a lack of tactile sensation and a reduced operative field view. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Learning Curve of Laparoscopic Colorectal Resections
- What is being tested?
- multi-slice Computed Tomography angiography and three-dimensional reconstruction software
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jan 2014
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included only patients in which standard laparoscopic right or left hemicolectomy was planned and who needed a CT scan but had not received a scan prior to their first office visit.
Who may be able to join
- Patients in which standard laparoscopic right or left hemicolectomy was planned
Who cannot join
- patients who underwent extended right hemicolectomy and segmental colectomy or sigmoidectomy and patients for whom the surgical technique was modified intraoperatively
- patients who underwent anterior rectal resection and emergency procedures for complicated diverticulitis were excluded because these procedures require higher technical skills.
- Patients who had an ASA score of IV, a BMI over 40 or contraindications for laparoscopy were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Preoperative Knowledge of the Colonic Vascular Anatomy on the Learning Curve for Laparoscopic Colorectal Resection
Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the well-known benefits and comparable oncological outcomes, it is still limited by a lack of tactile sensation and a reduced operative field view. In addition, the inconsistency in the number and course of the mesenteric vessels significantly influences the learning curve with 30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy can be mapped using CT-angiography, and the images can be processed with rendering software to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was to assess the influence of visualizing the three-dimensional vascular anatomy on the learning curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on the learning curve, we considered 2 groups of two surgeons with different levels of experience. In the first group (group A), the surgeons were able to view 3D reconstructions before and during the surgery, while the surgeons in Group B were only able to view the 3D reconstructions after surgery.
- Being tested
- multi-slice Computed Tomography angiography and three-dimensional reconstruction software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-slice Computed Tomography angiography and three-dimensional reconstruction softwareProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | the surgeons were able to view 3D reconstructions before and during surgery Receives: Procedure: multi-slice Computed Tomography angiography and three-dimensional reconstruction software | |
| Group B | the surgeons were only able to view 3D reconstructions after the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
Measured: operating time
Secondary outcomes (3)
intraoperative and postoperative complications
Measured: first 2 week after surgery
hospital stay
Measured: first 2 weeks after surgery
oncological clearance
radicality and number of harvested lymph nodes
Measured: first 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning Curve of Laparoscopic Colorectal ResectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Saverio Mari, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976000
- Sponsor's protocol ID
- DS-009
- Status last verified
- Feb 2014
- First submitted
- 29 Oct 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Knowledge of the Colonic Vascular Anatomy on the Learning Curve for Laparoscopic Colorectal Resection
- ClinicalTrials.gov ID
- NCT01976000
- Acronym / sponsor ID
- DS-009
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Nov 2013 (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.
Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the well-known benefits and comparable oncological outcomes, it is still limited by a lack of tactile sensation and a reduced operative field view. In addition, the inconsistency in the number and course of the mesenteric vessels significantly influences the learning curve with 30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy can be mapped using CT-angiography, and the images can be processed with rendering software to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was to assess the influence of visualizing the three-dimensional vascular anatomy on the learning curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on the learning curve, we considered 2 groups of two surgeons with different levels of experience. In the first group (group A), the surgeons were able to view 3D reconstructions before and during the surgery, while the surgeons in Group B were only able to view the 3D reconstructions after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: multi-slice Computed Tomography angiography and three-dimensional reconstruction softwarethe surgeons were able to view 3D reconstructions before and during surgery |
| Group B | – | –the surgeons were only able to view 3D reconstructions after the surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included only patients in which standard laparoscopic right or left hemicolectomy was planned and who needed a CT scan but had not received a scan prior to their first office visit.
Key inclusion criteria (1 listed)
- Patients in which standard laparoscopic right or left hemicolectomy was planned
Key exclusion criteria (3 listed)
- patients who underwent extended right hemicolectomy and segmental colectomy or sigmoidectomy and patients for whom the surgical technique was modified intraoperatively
- patients who underwent anterior rectal resection and emergency procedures for complicated diverticulitis were excluded because these procedures require higher technical skills.
- Patients who had an ASA score of IV, a BMI over 40 or contraindications for laparoscopy were also excluded.
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 |
|---|---|---|
| multi-slice Computed Tomography angiography and three-dimensional reconstruction software | Procedure or surgery | Group A |
Primary outcome
operating time
Time frame: operating time
3 secondary outcomes
intraoperative and postoperative complications
Time frame: first 2 week after surgery
hospital stay
Time frame: first 2 weeks after surgery
oncological clearance
Time frame: first 2 weeks after surgery
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 17 Mar 2015.
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?
An observational study of Learning Curve of Laparoscopic Colorectal Resections, run by University of Roma La Sapienza at 1 site in Italy.
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 1 inclusion and 3 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 17 Mar 2015. 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.
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?
operating time (time frame: operating time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.