Regional Anesthesia in Colon Rectal Surgery

Colon Cancer Clinical Trial

Official title:

Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00684229
• Other study ID #: 07-933
• Status: Withdrawn
• Phase: N/A
• First received: May 22, 2008
• Last updated: September 13, 2016
• Start date: December 2007
• Est. completion date: November 2013

Study information

• Verified date: September 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Procedure:
• Regional anesthesia and analgesia
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.

Drug:
• general anesthesia followed by opioid analgesia
sevoflurane general anesthesia and postoperative opioid analgesia

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Germany	University of Dusseldorf	Dusseldorf
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Argentina,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	days	No