Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up. Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients. At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood. Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.
Study Type
OBSERVATIONAL
Enrollment
1,386
During and 2 hrs after surgery
Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm
Time frame: 36-60 months after randomization
Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry
Time frame: 15-39 months after randomization
Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm
Time frame: 36-60 months after randomization
Frequency of patients with new histological specimen in the Danish Patobank showing neoplasm of a histological type not previously diagnosed
Time frame: 36-60 months after randomization
Frequency of patients with cancer as diagnosis code at a readmission
Time frame: 36-60 months after randomization
Frequency of patients with cancer as primary diagnosis code at a readmission
Time frame: 36-60 months after randomization
Duration of cancer-free survival, as assessed by Kaplan-Meier statistics
Time frame: 36-60 months after randomization
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