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Regional Anesthesia in Colon Rectal Surgery | Clinical Trials | Clareo Health

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WITHDRAWNNANCT00684229

Regional Anesthesia in 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 fol...

Lead sponsor: The Cleveland Clinic•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

The Cleveland Clinic

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.

Age

18 - 85 years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 15, 2016Terms

Trial snapshot

StatusWITHDRAWN

PhaseNA

Enrollment—

Start dateDec 2007

Last updatedSep 15, 2016

Condition

Locations shown

Cleveland Clinic

Cleveland, Ohio

Hospital Italiano de Buenos Aires

Buenos Aires

University of Dusseldorf

Düsseldorf

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions