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Regional Anesthesia in Colon Rectal Surgery

Primary Purpose

Colon Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Regional anesthesia and analgesia
general anesthesia followed by opioid analgesia
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer focused on measuring Anesthesia; regional, Cancer recurrence, Anesthesia; inhalational, Analgesia; opioid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic
  • Hospital Italiano de Buenos Aires
  • University of Dusseldorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Regional anesthesia and analgesia

general anesthesia followed by opioid analgesia

Arm Description

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

Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

length of post operative hospitalization
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.

Full Information

First Posted
May 22, 2008
Last Updated
September 13, 2016
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00684229
Brief Title
Regional Anesthesia in Colon Rectal Surgery
Official Title
Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
investigator could not identify any patients
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Anesthesia; regional, Cancer recurrence, Anesthesia; inhalational, Analgesia; opioid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia and analgesia
Arm Type
Active Comparator
Arm Description
Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).
Arm Title
general anesthesia followed by opioid analgesia
Arm Type
Active Comparator
Arm Description
Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.
Intervention Type
Procedure
Intervention Name(s)
Regional anesthesia and analgesia
Intervention Description
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
Intervention Type
Drug
Intervention Name(s)
general anesthesia followed by opioid analgesia
Intervention Description
sevoflurane general anesthesia and postoperative opioid analgesia
Primary Outcome Measure Information:
Title
cancer recurrence
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
length of post operative hospitalization
Description
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.
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel I Sessler, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Kurz, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
University of Dusseldorf
City
Dusseldorf
ZIP/Postal Code
101007
Country
Germany

12. IPD Sharing Statement

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Regional Anesthesia in Colon Rectal Surgery

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