Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,386
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
80% oxygen group
干预措施: Oxygen (Drug)
30% oxygen group
干预措施: Oxygen (Drug)
结局指标
主要结局
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
时间窗: 36-60 months after randomization
次要结局
- 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)
- 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)
研究者
Lars S. Rasmussen
Professor, MD, PhD, DMSc
Rigshospitalet, Denmark