Colorectal CancerPhase 4NCT00942461
Inflammatory Response in Laparoscopic and Open Colectomy
A Phase 4 study testing Laparoscopic colectomy and Open colectomy in people with Colorectal Cancer, run by G. Hatzikosta General Hospital at 1 site in Greece.
Trial summary
This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Laparoscopic colectomy and Open 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
- Oct 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
- Child, Adult, Older adult
Who may be able to join
- colorectal cancer
Who cannot join
- metastases
- stage 4 colorectal cancer
- recurrent disease
- chronic diseases
- obvious inflammatory condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery
This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery
- Conditions
- Colorectal Cancer
- Being tested
- Laparoscopic colectomy, Open colectomy
- Keywords
- a-defensins, TLRs, Inflammatory Cytokines, CRP, No metastases, No other obvious inflammation, No chronic diseases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colectomyProcedure or surgery
Laparoscopic colectomy. Epidural anaesthesia used
Open colectomyProcedure or surgery
Open colectomy. Epidural anaesthesia used
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery group | Active comparator | Group of patients that are operated with laparoscopic approach Receives: Procedure: Laparoscopic colectomy |
| Open surgery Group | Active comparator | Group of patients operated with open approach Receives: Procedure: Open colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer
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 posted21 Jul 2009 (estimated)
- Study startOct 2008
- Primary completionJun 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 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
- NCT00942461
- Sponsor's protocol ID
- GH-1948-04
- Other IDs
- GHDS-12345-4
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsimogiannis KE, Tellis CC, Tselepis AD, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Toll-like receptors in the inflammatory response during open and laparoscopic colectomy for colorectal cancer. Surg Endosc. 2012 Feb;26(2):330-6. doi: 10.1007/s00464-011-1871-2. Epub 2011 Sep 5.
PubMed 21898023Tsimogiannis KE, Telis K, Tselepis A, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Alpha-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer. World J Surg. 2011 Aug;35(8):1911-7. doi: 10.1007/s00268-011-1140-5.
PubMed 21567262
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT00942461
- Acronym / sponsor ID
- GH-1948-04
- Conditions
- Colorectal Cancer
- Keywords
- a-defensins, TLRs, Inflammatory Cytokines, CRP, No metastases, No other obvious inflammation, No chronic diseases
- 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
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- First posted
- 21 Jul 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.
This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery group | Active comparator | Procedure: Laparoscopic colectomyGroup of patients that are operated with laparoscopic approach |
| Open surgery Group | Active comparator | Procedure: Open colectomyGroup of patients operated with open approach |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- colorectal cancer
Key exclusion criteria (5 listed)
- metastases
- stage 4 colorectal cancer
- recurrent disease
- chronic diseases
- obvious inflammatory condition
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 colectomyLaparoscopic colectomy. Epidural anaesthesia used | Procedure or surgery | Laparoscopic Surgery group |
| Open colectomyOpen colectomy. Epidural anaesthesia used | Procedure or surgery | Open surgery Group |
Primary outcome
Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer
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 21 Jul 2009.
- Derived from this study: PubMed 21898023Tsimogiannis KE, Tellis CC, Tselepis AD, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Toll-like receptors in the inflammatory response during open and laparoscopic colectomy for colorectal cancer. Surg Endosc. 2012 Feb;26(2):330-6. doi: 10.1007/s00464-011-1871-2. Epub 2011 Sep 5.
- Derived from this study: PubMed 21567262Tsimogiannis KE, Telis K, Tselepis A, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Alpha-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer. World J Surg. 2011 Aug;35(8):1911-7. doi: 10.1007/s00268-011-1140-5.
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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 Laparoscopic colectomy and Open 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 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 21 Jul 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?
Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer (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 NCT00942461, 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 21 Jul 2009; AzTrials last refreshed its copy on 30 Oct 2026.