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clinical trial
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and you are
over 18
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This is an observational trial.
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The purpose

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.

Provided treatments

  • Drug: Oxygen

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01723280. The sponsor of the trial is Lars S. Rasmussen and it is looking for 1386 volunteers for the current phase.
Official trial title:
Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)