NCT00684229

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

5.9 years

First QC Date

May 22, 2008

Last Update Submit

September 13, 2016

Conditions

Colon Cancer

Keywords

Anesthesia; regionalCancer recurrenceAnesthesia; inhalationalAnalgesia; opioid

Outcome Measures

Primary Outcomes (1)

  • 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

    5 years

Secondary Outcomes (1)

  • length of post operative hospitalization

    days

Study Arms (2)

Regional anesthesia and analgesia

ACTIVE COMPARATOR

Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).

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.

Drug: general anesthesia followed by opioid analgesia

Interventions

Regional anesthesia and analgesiaPROCEDURE

Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.

Regional anesthesia and analgesia
general anesthesia followed by opioid analgesiaDRUG

sevoflurane general anesthesia and postoperative opioid analgesia

general anesthesia followed by opioid analgesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

University of Dusseldorf

Düsseldorf, 101007, Germany

Location

MeSH Terms

Conditions

Colonic NeoplasmsAgnosia

Interventions

Anesthesia, ConductionAnalgesia

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Daniel I Sessler, MD

    The Cleveland Clinic

    STUDY CHAIR

  • Andrea Kurz, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

December 1, 2007

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

US(1)DE(1)AR(1)