Colon CancerNCT00684229
Regional Anesthesia in Colon Rectal Surgery
A study testing Regional anesthesia and analgesia and general anesthesia followed by opioid analgesia in people with Colon Cancer, run by The Cleveland Clinic at 3 sites in 3 countries.
Trial summary
This study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Regional anesthesia and analgesia and general anesthesia followed by opioid analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2007to Nov 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary colon cancer without known extension beyond colon (T3, N0, M0)
- Scheduled for open, laparoscopic assisted and laparoscopic resection of the colon.
- Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia or to sevoflurane general anesthesia and postoperative opioid analgesia.
Who cannot join
- Previous surgery for colon cancer;
- Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy);
- Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine;
- Age <18 or >85 years old;
- ASA Physical Status ≥4;
- Other cancer not believed by the attending surgeon to be in long-term remission;
- Systemic disease believed by the attending surgeon or anesthesiologist to present ≥25% two-year mortality.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery
This study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia.
Read the detailed description
The study population will consist of patients who are scheduled for open laparoscopic or laparoscopic assisted surgery for colon cancer. Patients will randomized into one of two groups. The intervention group will receive combined regional and general anesthesia during surgery. Postoperative pain treatment will be based on regional anesthesia techniques. The Control group will receive general anesthesia during surgery. Postoperative pain treatment will be based primarily on opioids. After surgery, patients will be followed daily during their hospital stay. Patients will be contacted by telephone every 6 months for five years. Quality of life questionnaires will be administered at these follow ups.
- Conditions
- Colon Cancer
- Being tested
- Regional anesthesia and analgesia, general anesthesia followed by opioid analgesia
- Keywords
- Anesthesia; regional, Cancer recurrence, Anesthesia; inhalational, Analgesia; opioid
- Medical subject headings
- Colonic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesia and analgesiaProcedure or surgery
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
general anesthesia followed by opioid analgesiaDrug
sevoflurane general anesthesia and postoperative opioid analgesia
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia and analgesia | Active comparator | Regional anesthesia and analgesia (either epidural or paravertebral anesthesia). Receives: Procedure: Regional anesthesia and analgesia |
| general anesthesia followed by opioid analgesia | Active comparator | Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia. Receives: Drug: general anesthesia followed by opioid analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer recurrence
To determine if recurrence of local/metastatic cancer after open and laparoscopic resection colon cancers is lower in patients randomized to epidural anesthesia \& analgesia than to sevoflurane general anesthesia and postoperative opioid analgesia
Measured: 5 years
Secondary outcomes (1)
length of post operative hospitalization
To determine if the length of post operative hospitalization is shortened in patients randomized to epidural anesthesia \& analgesia than to sevoflurane general anesthesia and postoperative opioid analgesia.
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: investigator could not identify any patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Kurz, The Cleveland Clinic
- Investigators
- Daniel I Sessler, MD, Study chair, The Cleveland ClinicAndrea Kurz, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684229
- Sponsor's protocol ID
- 07-933
- Status last verified
- Sep 2016
- First submitted
- 22 May 2008
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery
- ClinicalTrials.gov ID
- NCT00684229
- Acronym / sponsor ID
- 07-933
- Conditions
- Colon Cancer
- Keywords
- Anesthesia; regional, Cancer recurrence, Anesthesia; inhalational, Analgesia; opioid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigator could not identify any patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 May 2008 (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 will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia.
Detailed description
The study population will consist of patients who are scheduled for open laparoscopic or laparoscopic assisted surgery for colon cancer. Patients will randomized into one of two groups. The intervention group will receive combined regional and general anesthesia during surgery. Postoperative pain treatment will be based on regional anesthesia techniques. The Control group will receive general anesthesia during surgery. Postoperative pain treatment will be based primarily on opioids. After surgery, patients will be followed daily during their hospital stay. Patients will be contacted by telephone every 6 months for five years. Quality of life questionnaires will be administered at these follow ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia and analgesia | Active comparator | Procedure: Regional anesthesia and analgesiaRegional anesthesia and analgesia (either epidural or paravertebral anesthesia). |
| general anesthesia followed by opioid analgesia | Active comparator | Drug: general anesthesia followed by opioid analgesiaSubjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary colon cancer without known extension beyond colon (T3, N0, M0)
- Scheduled for open, laparoscopic assisted and laparoscopic resection of the colon.
- Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia or to sevoflurane general anesthesia and postoperative opioid analgesia.
Key exclusion criteria (7 listed)
- Previous surgery for colon cancer;
- Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy);
- Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine;
- Age <18 or >85 years old;
- ASA Physical Status ≥4;
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 |
|---|---|---|
| Regional anesthesia and analgesiaPost-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine. | Procedure or surgery | Regional anesthesia and analgesia |
| general anesthesia followed by opioid analgesiasevoflurane general anesthesia and postoperative opioid analgesia | Drug | general anesthesia followed by opioid analgesia |
Primary outcome
cancer recurrence
Time frame: 5 years
To determine if recurrence of local/metastatic cancer after open and laparoscopic resection colon cancers is lower in patients randomized to epidural anesthesia \& analgesia than to sevoflurane general anesthesia and postoperative opioid analgesia
1 secondary outcome
length of post operative hospitalization
Time frame: days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 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.
Daniel I Sessler, MD study chair
The Cleveland Clinic
Andrea Kurz, MD principal investigator
The Cleveland Clinic
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anesthesia and analgesia and general anesthesia followed by opioid analgesia in people with Colon Cancer, run by The Cleveland Clinic at 3 sites in 3 countries.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Argentina, Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
cancer recurrence (time frame: 5 years). 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 15 Sep 2016.