Colorectal CancerPhase 4NCT00928928
Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer
A Phase 4 study testing Open colectomy and laparoscopic colectomy in people with Colorectal Cancer, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Open colectomy and laparoscopic colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2008to Jun 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- colorectal cancer
Who cannot join
- metastases
- recurrent disease
- chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach
Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- Open colectomy, laparoscopic colectomy
- Keywords
- Lipid peroxidation, Protein peroxidation, DNA peroxidation, RNA peroxidation, Cytokines, hsCRP, Oxidative stress markers, Open surgery, Laparoscopic surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open colectomyProcedure or surgery
Open colectomy. Epidural anaesthesia used
laparoscopic colectomyProcedure or surgery
Laparoscopic colectomy. Epidural anaesthesia used
| Study group | Role | What they receive |
|---|---|---|
| Open group | Active comparator | Group of patients operated with open approach for colorectal cancer Receives: Procedure: Open colectomy |
| laparoscopic group | Active comparator | Group of patients operated with laparoscopic approach for colorectal cancer Receives: Procedure: laparoscopic colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach
Measured: preoperative, intraoperative, 6h postop, 24h postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2009
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 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. Hatzikosta General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928928
- Sponsor's protocol ID
- GH-1948-03
- Other IDs
- GHDS-12345-3
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2009
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pappas-Gogos G, Tellis C, Lasithiotakis K, Tselepis AD, Tsimogiannis K, Tsimoyiannis E, Chalkiadakis G, Chrysos E. Oxidative stress markers in laparoscopic versus open colectomy for cancer: a double-blind randomized study. Surg Endosc. 2013 Jul;27(7):2357-65. doi: 10.1007/s00464-013-2788-8. Epub 2013 Feb 13.
PubMed 23404145
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach
- ClinicalTrials.gov ID
- NCT00928928
- Acronym / sponsor ID
- GH-1948-03
- Conditions
- Colorectal Cancer
- Keywords
- Lipid peroxidation, Protein peroxidation, DNA peroxidation, RNA peroxidation, Cytokines, hsCRP, Oxidative stress markers, Open surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- G. Hatzikosta General HospitalUniversity, hospital or other
- Collaborators
- University of Ioannina
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- First posted
- 26 Jun 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.
Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open group | Active comparator | Procedure: Open colectomyGroup of patients operated with open approach for colorectal cancer |
| laparoscopic group | Active comparator | Procedure: laparoscopic colectomyGroup of patients operated with laparoscopic approach for colorectal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- colorectal cancer
Key exclusion criteria (3 listed)
- metastases
- recurrent disease
- chronic diseases
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 |
|---|---|---|
| Open colectomyOpen colectomy. Epidural anaesthesia used | Procedure or surgery | Open group |
| laparoscopic colectomyLaparoscopic colectomy. Epidural anaesthesia used | Procedure or surgery | laparoscopic group |
Primary outcome
Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach
Time frame: preoperative, intraoperative, 6h postop, 24h postop
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 26 Jun 2009.
- Derived from this study: PubMed 23404145Pappas-Gogos G, Tellis C, Lasithiotakis K, Tselepis AD, Tsimogiannis K, Tsimoyiannis E, Chalkiadakis G, Chrysos E. Oxidative stress markers in laparoscopic versus open colectomy for cancer: a double-blind randomized study. Surg Endosc. 2013 Jul;27(7):2357-65. doi: 10.1007/s00464-013-2788-8. Epub 2013 Feb 13.
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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.
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?
A Phase 4 study testing Open colectomy and laparoscopic colectomy in people with Colorectal Cancer, run by G. Hatzikosta General Hospital at 1 site in Greece.
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 26 Jun 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 Greece. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach (time frame: preoperative, intraoperative, 6h postop, 24h postop). 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 NCT00928928, 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 26 Jun 2009.