LaparoscopyPhase 2NCT01040013
Gut Oxygenation and Laparoscopy
A Phase 2 study testing Laparoscopy and left colectomy by laparotomy in people with Laparoscopy and Laparotomy, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopy, Laparotomy, Oxygenation,
- What is being tested?
- Laparoscopy and left colectomy by laparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2008to Sep 2009
- Phase
- Phase 2
- 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
Who may be able to join
- Proven Cleft Colon Cancer, Signed Informed Consent
Who cannot join
- Emergency surgery,
- Cancer infiltrating adjacent organ (at CT scan),
- Severe cardiovascular (New York Heart Association class > 3 ),
- Respiratory (arterial PO2 < 70 mmHg),
- Renal (plasma creatinine > 3 MG/dL) or hepatic (Child C) dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.
- Conditions
- Laparoscopy, Laparotomy, Oxygenation,, Ischemia-Reperfusion Injury
- Being tested
- Laparoscopy, left colectomy by laparotomy
- Keywords
- LAPAROSCOPY,, LAPAROTOMY,, OXYGENATION,, ISCHEMIA-REPERFUSION INJURY
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Laparoscopic Left-Colectomy
left colectomy by laparotomyProcedure or surgery
PatientS will be operated by laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Experimental | Laparoscopic Left-Sided Colectomy Receives: Procedure: Laparoscopy |
| laparotomy | Active comparator | Laparotomic Left-Sided Colectomy Receives: Procedure: left colectomy by laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal oxygenation
Measured: 7 DAYS
Secondary outcomes (1)
Ischemic reperfusion injury
Measured: 7 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaparoscopyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Investigators
- Luca Gianotti, MD, PhD, Principal investigator, Milano-Bicocca university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040013
- Sponsor's protocol ID
- oxylap-2009
- Status last verified
- Nov 2009
- First submitted
- 24 Dec 2009
- Last updated
- 25 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.
PubMed 9736317Gianotti L, Nespoli L, Rocchetti S, Vignali A, Nespoli A, Braga M. Gut oxygenation and oxidative damage during and after laparoscopic and open left-sided colon resection: a prospective, randomized, controlled clinical trial. Surg Endosc. 2011 Jun;25(6):1835-43. doi: 10.1007/s00464-010-1475-2. Epub 2010 Dec 7.
PubMed 21136109
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT01040013
- Acronym / sponsor ID
- oxylap-2009
- Conditions
- Laparoscopy, Laparotomy, Oxygenation,, Ischemia-Reperfusion Injury
- Keywords
- LAPAROSCOPY,, LAPAROTOMY,, OXYGENATION,, ISCHEMIA-REPERFUSION INJURY
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Dec 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.
Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | Experimental | Procedure: LaparoscopyLaparoscopic Left-Sided Colectomy |
| laparotomy | Active comparator | Procedure: left colectomy by laparotomyLaparotomic Left-Sided Colectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Proven Cleft Colon Cancer, Signed Informed Consent
Key exclusion criteria (5 listed)
- Emergency surgery,
- Cancer infiltrating adjacent organ (at CT scan),
- Severe cardiovascular (New York Heart Association class > 3 ),
- Respiratory (arterial PO2 < 70 mmHg),
- Renal (plasma creatinine > 3 MG/dL) or hepatic (Child C) dysfunction
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 |
|---|---|---|
| LaparoscopyLaparoscopic Left-Colectomy | Procedure or surgery | Laparoscopy |
| left colectomy by laparotomyPatientS will be operated by laparotomy | Procedure or surgery | laparotomy |
Primary outcome
Intestinal oxygenation
Time frame: 7 DAYS
1 secondary outcome
Ischemic reperfusion injury
Time frame: 7 DAYS
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 25 Dec 2009.
- Background: PubMed 9736317Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. doi: 10.3109/10715769809065821.
- Derived from this study: PubMed 21136109Gianotti L, Nespoli L, Rocchetti S, Vignali A, Nespoli A, Braga M. Gut oxygenation and oxidative damage during and after laparoscopic and open left-sided colon resection: a prospective, randomized, controlled clinical trial. Surg Endosc. 2011 Jun;25(6):1835-43. doi: 10.1007/s00464-010-1475-2. Epub 2010 Dec 7.
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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.
Luca Gianotti, MD, PhD principal investigator
Milano-Bicocca university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopy and left colectomy by laparotomy in people with Laparoscopy and Laparotomy, run by University of Milano Bicocca 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 5 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 25 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Intestinal oxygenation (time frame: 7 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 NCT01040013, which also lists 2 linked publications.
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 25 Dec 2009.