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| ID | Type | Description | Link |
|---|---|---|---|
| GCP-2006-101 | Other Identifier | Danish GCP-unit | |
| KF 02 306766 | Other Identifier | Ethics committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80% oxygen group |
| ||
| 30% oxygen group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | During and 2 hrs after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36-60 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry | 15-39 months after randomization | |
| Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm | 36-60 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Type of new cancer registration | 15-39 months after randomization | |
| Histological type of new cancer specimen | 36-60 months after randomization | |
| Cause of death |
Inclusion Criteria:
Exclusion Criteria:
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Participants in the PROXI trial
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| Name | Affiliation | Role |
|---|---|---|
| Christian S Meyhoff, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18945347 | Background | Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Helto K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial. Trials. 2008 Oct 22;9:58. doi: 10.1186/1745-6215-9-58. | |
| 19826023 |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Frequency of patients with new histological specimen in the Danish Patobank showing neoplasm of a histological type not previously diagnosed | 36-60 months after randomization |
| Frequency of patients with cancer as diagnosis code at a readmission | 36-60 months after randomization |
| Frequency of patients with cancer as primary diagnosis code at a readmission | 36-60 months after randomization |
| Duration of cancer-free survival, as assessed by Kaplan-Meier statistics | 36-60 months after randomization |
| 15-39 months after randomization |
| Background |
| Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452. |
| 24860156 | Derived | Meyhoff CS, Jorgensen LN, Wetterslev J, Siersma VD, Rasmussen LS; PROXI Trial Group. Risk of new or recurrent cancer after a high perioperative inspiratory oxygen fraction during abdominal surgery. Br J Anaesth. 2014 Jul;113 Suppl 1:i74-i81. doi: 10.1093/bja/aeu110. Epub 2014 May 23. |