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Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery


N/A
18 Years
85 Years
Open (Enrolling)
Both
Colon Cancer

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Trial Information

Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

cancer recurrence

Outcome Description:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Daniel I Sessler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

07-933

NCT ID:

NCT00684229

Start Date:

December 2007

Completion Date:

December 2022

Related Keywords:

  • Colon Cancer
  • Anesthesia; regional
  • Cancer recurrence
  • Anesthesia; inhalational
  • Analgesia; opioid
  • Colonic Neoplasms

Name

Location
Cleveland Clinic Cleveland, Ohio  44195