Colon Cancer
Conditions
Keywords
Anesthesia; regional, Cancer recurrence, Anesthesia; inhalational, Analgesia; opioid
Brief 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.
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.
Interventions
PROCEDURERegional anesthesia and analgesia
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
DRUGgeneral anesthesia followed by opioid analgesia
sevoflurane general anesthesia and postoperative opioid analgesia
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cancer recurrence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of post operative hospitalization | days | 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. |
Countries
Argentina, Germany, United States
Outcome results
None listed