Laparotomy
Conditions
Brief summary
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.
Interventions
DRUGOxygen
During and 2 hrs after surgery
Sponsors
Lars S. Rasmussen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index \>200 or a specimen with atypical or neoplastic cells).
Exclusion criteria
* Other surgery within 30 days (except surgery in local anaesthesia). * Chemotherapy within 3 months. * Inability to give informed consent. * Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Cause of death | 15-39 months after randomization |
| Type of new cancer registration | 15-39 months after randomization |
| Histological type of new cancer specimen | 36-60 months after randomization |
Countries
Denmark
Outcome results
None listed