Colorectal CancerCRCNCT01427647
Inflammatory Response After Colorectal Cancer Surgery
A study testing Laparoscopic technique and thoracic epidural anesthesia in people with Colorectal Cancer, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Laparoscopic technique and thoracic epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2007to Feb 2010
- Phase
- Interventional
- 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
- Patients scheduled for colorectal cancer surgery
Who cannot join
- Emergent surgery
- Intestinal obstruction
- Contraindication for epidural catheter placement
- Concomitant autoimmune disease
- Concomitant infectious disease
- Recent corticosteroids or anti-inflammatory medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery
Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.
Read the detailed description
Patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (CON group, n=22) or general anesthesia with thoracic epidural anesthesia (EPI group, n=21). Patients undergoing laparoscopic surgery (LAP group, n=20) composed the third arm of the study. Measurement of perioperative changes in several hormones and cytokines were blinded to group assignment.
Primary outcome: Compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.
- Conditions
- Colorectal Cancer
- Being tested
- Laparoscopic technique and thoracic epidural anesthesia
- Keywords
- Laparoscopy, Anesthesia, Epidural
- 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 technique and thoracic epidural anesthesiaProcedure or surgery
We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Control group: open surgery under general anesthesia Receives: Procedure: Laparoscopic technique and thoracic epidural anesthesia |
| Epidural group | Active comparator | Epidural group: Open surgery under thoracic epidural anesthesia Receives: Procedure: Laparoscopic technique and thoracic epidural anesthesia |
| Laparoscopic group | Active comparator | Laparoscopic group: Laparoscopic surgery under general anesthesia Receives: Procedure: Laparoscopic technique and thoracic epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of several cytokines after colorectal cancer surgery
We have measured and compared perioperative plasma levels of interleukin-1, interleukin-2, interleukin-6,monocyte chemotactic protein-1, interleukin-8, nitric oxide, C-reactive protein and procalcitonin in our three-group sample.
Measured: within the first two days after surgery
Secondary outcomes (1)
Incidence of adverse clinical outcomes between groups
We have analyzed if there is any significant difference on respiratory, cardiac, renal or infectious postoperative complications between groups
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJun 2007
- Primary completionMay 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Responsible party
- Principal investigator, Patricia Duque, M.D., Universidad Complutense de Madrid
- Investigators
- Patricia Duque, MD, Principal investigator, Gregorio Marañon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427647
- Sponsor's protocol ID
- Complutense University 1
- Acronym
- CRC
- Status last verified
- Jul 2016
- First submitted
- 29 Aug 2011
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery
- ClinicalTrials.gov ID
- NCT01427647
- Acronym / sponsor ID
- CRC / Complutense University 1
- Conditions
- Colorectal Cancer
- Keywords
- Laparoscopy, Anesthesia, Epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Study start
- Jun 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Sep 2011 (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 technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.
Detailed description
Patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (CON group, n=22) or general anesthesia with thoracic epidural anesthesia (EPI group, n=21). Patients undergoing laparoscopic surgery (LAP group, n=20) composed the third arm of the study. Measurement of perioperative changes in several hormones and cytokines were blinded to group assignment.
Primary outcome: Compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Laparoscopic technique and thoracic epidural anesthesiaControl group: open surgery under general anesthesia |
| Epidural group | Active comparator | Procedure: Laparoscopic technique and thoracic epidural anesthesiaEpidural group: Open surgery under thoracic epidural anesthesia |
| Laparoscopic group | Active comparator | Procedure: Laparoscopic technique and thoracic epidural anesthesiaLaparoscopic group: Laparoscopic surgery under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for colorectal cancer surgery
Key exclusion criteria (6 listed)
- Emergent surgery
- Intestinal obstruction
- Contraindication for epidural catheter placement
- Concomitant autoimmune disease
- Concomitant infectious disease
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 technique and thoracic epidural anesthesiaWe have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques | Procedure or surgery | Control group, Epidural group, Laparoscopic group |
Primary outcome
Plasma levels of several cytokines after colorectal cancer surgery
Time frame: within the first two days after surgery
We have measured and compared perioperative plasma levels of interleukin-1, interleukin-2, interleukin-6,monocyte chemotactic protein-1, interleukin-8, nitric oxide, C-reactive protein and procalcitonin in our three-group sample.
1 secondary outcome
Incidence of adverse clinical outcomes between groups
Time frame: within 30 days 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 22 Jul 2016.
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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.
Patricia Duque, MD principal investigator
Gregorio Marañon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic technique and thoracic epidural anesthesia in people with Colorectal Cancer, run by Universidad Complutense de Madrid at 1 site in Spain.
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 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 22 Jul 2016. 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 Spain. 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?
Plasma levels of several cytokines after colorectal cancer surgery (time frame: within the first two days after surgery). 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 22 Jul 2016.