Colon CancerPhase 3NCT00894725
Laparoscopic Versus Open Left Colonic Resection
A Phase 3 study testing laparoscopic left colonic resection and open left colonic resection in people with Colon Cancer and Benign Disease, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection. 268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Benign Disease
- What is being tested?
- laparoscopic left colonic resection and open left colonic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2000to Dec 2008
- 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
- age > 18 years
- suitability to elective surgery
Who cannot join
- cancer infiltrating adjacent organs assessed by computed tomography
- cardiovascular dysfunction (New York Heart Association class > 3)
- respiratory dysfunction (arterial pO2 < 70 mmHg)
- hepatic dysfunction (Child-Pugh class C)
- ongoing infection
- plasma neutrophil level < 2.0x109/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.
268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.
Read the detailed description
The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.
Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.
- Conditions
- Colon Cancer, Benign Disease
- Being tested
- laparoscopic left colonic resection, open left colonic resection
- Keywords
- left colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic left colonic resectionProcedure or surgery
laparoscopic colonic resection
open left colonic resectionProcedure or surgery
conventional open colonic resection
| Study group | Role | What they receive |
|---|---|---|
| LPS | Experimental | laparoscopic left colonic resection Receives: Procedure: laparoscopic left colonic resection |
| Open | Active comparator | open left colonic resection Receives: Procedure: open left colonic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term morbidity rate
Measured: 30 days
Secondary outcomes (1)
long-term outcome
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startFeb 2000
- Primary completionDec 2004
- Study completionDec 2008
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 Colon CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Marco Braga, MD, Study director, San Raffaele Vita-Salute University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894725
- Sponsor's protocol ID
- hmsxLPS09
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.
PubMed 20602506
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
- ClinicalTrials.gov ID
- NCT00894725
- Acronym / sponsor ID
- hmsxLPS09
- Conditions
- Colon Cancer, Benign Disease
- Keywords
- left colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Feb 2000
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 May 2009 (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.
The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.
268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.
Detailed description
The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.
Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPS | Experimental | Procedure: laparoscopic left colonic resectionlaparoscopic left colonic resection |
| Open | Active comparator | Procedure: open left colonic resectionopen left colonic 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)
- age > 18 years
- suitability to elective surgery
Key exclusion criteria (6 listed)
- cancer infiltrating adjacent organs assessed by computed tomography
- cardiovascular dysfunction (New York Heart Association class > 3)
- respiratory dysfunction (arterial pO2 < 70 mmHg)
- hepatic dysfunction (Child-Pugh class C)
- ongoing infection
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 left colonic resectionlaparoscopic colonic resection | Procedure or surgery | LPS |
| open left colonic resectionconventional open colonic resection | Procedure or surgery | Open |
Primary outcome
short-term morbidity rate
Time frame: 30 days
1 secondary outcome
long-term outcome
Time frame: 5 years
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 7 May 2009.
- Derived from this study: PubMed 20602506Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.
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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.
Marco Braga, MD study director
San Raffaele Vita-Salute University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laparoscopic left colonic resection and open left colonic resection in people with Colon Cancer and Benign Disease, run by Università Vita-Salute San Raffaele 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 2 inclusion and 6 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 7 May 2009. 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?
short-term morbidity rate (time frame: 30 days). 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 NCT00894725, 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 7 May 2009.