Status:
WITHDRAWN
Regional Anesthesia in Colon Rectal Surgery
Lead Sponsor:
The Cleveland Clinic
Conditions:
Colon Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 fol...
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 interventi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00684229
Start Date
December 1 2007
End Date
November 1 2013
Last Update
September 15 2016
Active Locations (3)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
2
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
3
University of Dusseldorf
Düsseldorf, Germany, 101007