Cancer Mortality Affected by the Choice of Anesthetic Drugs?
Recruitment status was Active, not recruiting
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Purpose
Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?
Aim: To retrospectively examine possible associations (Cox Multiple Regression) between survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during surgery, ahead of a prospective randomised controlled trial.
Hypotheses: One- and five-year survival will be significantly higher after radical breast-, colorectal-, or skin cancer surgery in patients given the intravenously administered hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.
Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical data from 6 303 patients operated on at the three mentioned anatomical locations at the Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these minimum 4 500 operations would be due to cancer. This register is unique, in that it contains both types of anaesthesia. The other register holds survival data (date and cause of death), stored at the Regional Oncologic Center in Uppsala.
The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper file, concomitantly with extraction of details from anaesthesia and surgery, such as the functional classification of each patient (according to American Association of Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss and possible transfusion.
Current knowledge: Different anaesthetics have opposite effects on the immune system and on the DNA. There is a well-established association between the state of the immune system and cancer growth, which in turn will influence survival. There is also an association between DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory and anti-oxidative, and it is not genotoxic.
Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in advance of a multi-centre, prospective, randomised, controlled trial.
Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired effects from anaesthesia on survival has strong relevance for the over all cancer treatment.
| Condition |
|---|
|
Breast Cancer Colo-rectal Cancer Skin Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Cancer Mortality Affected by the Choice of Anesthetic Drugs? |
- Survival [ Time Frame: One year from index procedure ] [ Designated as safety issue: No ]
- Survival [ Time Frame: Five years from index procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4500 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Sevoflurane
Sevoflurane exposure for radical cancer surgery
|
|
Propofol
Propofol exposure for cancer surgery
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients operated on for cancer in breast, colo-rectally, or in skin at a single institution from Jan 1, 1998 to Dec 31, 2009.
Inclusion Criteria:
- Exposed to general anesthesia for surgical removal of cancer in breast, colo-rectally, or in skin
Exclusion Criteria:
- Paper file unable to find or missing data in anesthetic file or in outcome registry
Contacts and Locations| Sweden | |
| Uppsala University, Centre for Clinical Research-Vasteras | |
| Vasteras, Sweden, SE-72189 | |
| Principal Investigator: | Mats Enlund, M.D., Ph.D. | Uppsala University, Centre for Clinical Research-Vasteras |
| Study Director: | Leif Bergkvist, M.D., Ph.D. | Uppsala University, Centre for Clinnical Research-Vasteras |
| Study Chair: | Mats Lambe, M.D., Ph.D. | Uppsala University, Regional Oncologic Centre |
More Information
No publications provided
| Responsible Party: | Assoc. Prof. Mats enlund, Uppsala University, Centre for Clinical Research-Vasteras |
| ClinicalTrials.gov Identifier: | NCT01418326 History of Changes |
| Other Study ID Numbers: | 2008350 |
| Study First Received: | May 12, 2011 |
| Last Updated: | August 16, 2011 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Uppsala University:
|
Cancer - breast colo-rectal skin |
Additional relevant MeSH terms:
|
Breast Neoplasms Rectal Neoplasms Skin Neoplasms Colorectal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013