Epidural use and cancer recurrence

None listed

We plan to undertake an observational "follow-up" study of The MASTER Trial (Alfred EC approval 98/94). The MASTER Trial was conducted between 1995 and 2001. The study consisted of 915 high-risk patients (ASA III-IV) having major abdominal surgery. Many of these patients underwent cancer surgery. Half of the patients in The MASTER Trial received epidural analgesia. We aim to identify whether epidural analgesia protects the immune system during and early after surgery and thus reduces later cancer recurrence. Those We intend to follow uo all MASTER Trial patients who had surgery for cancer will be followed up to determine if their cancer has returned and when it returned. See attached Telephone interview and Protocol 4. AThere are no new interventions and all patients have previously provided informed consent to the original study but this did not include contact for future research. The study does not require any new interventions and will involve involve looking through the histories of patients enrolled in The MASTER Trial to determine whether their original surgery was for excision of cancer, therefore making them eligible for inclusion in this follow-up study. All eligible patients will then be screened by the Victorian Cancer Council’s (VCC) Database to identify patients who are no longer living. The VCC Database will also provide valuable information regarding cause of death. Information regarding deceased patients will prevent researchers from attempting to contact next of kin and causing unnecessary distress. All patients not listed as having died will be contacted by phone and asked to answer a brief questionnaire regarding their health.and also ringing some patients up. Patients who cannot be contacted by phone after 3 attempts will be sent a questionnaire. Researchers will approach GPs and / or next of kin of patients who we are unable to contact. In the event that researchers are unable to contact patients, GPs or next-of-kin, we will attempt to follow-up patients using a national death index, the Western Australian cancer registry and medical records. The primary endpoints are the recurrence of cancer within 5 years of initial surgery, and cancer-related deaths. Secondary endpoints are the type of cancer recurrence: local, regional or distal, and survival. Researchers will undertake a feasibility study of the Alfred’s 180 patients over an estimated 6 months, prior to following up patients at other centres.