NCT06989346

Impact of Perioperative Hyperoxia on Cancer Recurrence and Mortality After Elective Colorectal Cancer Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 403 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate whether perioperative hyperoxia (FiO₂ \> 0.8), compared to conventional oxygen therapy (FiO₂ \< 0.4), is associated with increased cancer recurrence and mortality in patients undergoing curative elective colorectal cancer surgery.

Detailed description

In 2016, the World Health Organization (WHO) recommended the use of perioperative hyperoxia (FiO₂ \> 0.8) to reduce the risk of postoperative surgical site infections (SSIs). However, the WHO also highlighted potential adverse effects associated with hyperoxia, including increased cancer recurrence and mortality. This study aims to evaluate whether perioperative hyperoxia (FiO₂ \> 0.8), compared to conventional oxygen therapy (FiO₂ \< 0.4), is associated with increased cancer recurrence and mortality in patients undergoing curative elective colorectal cancer surgery. This study is a follow-up of a previously published cohort originally designed to assess whether FiO₂ \> 0.8 was associated with a higher incidence of perioperative cardiovascular complications. In this follow-up, oncological recurrence and mortality events were recorded at least three years after the index surgery. The primary outcome was recurrence-free survival over the follow-up period, analyzed using Kaplan-Meier curves and a Cox proportional hazards model. The secondary outcome was the 3-year mortality rate, analyzed using the Chi-square test.

Conditions

• Recurrence
• Survival Rate
• Mortality
• Colorectal Surgery
• Hyperoxia

Timeline

• Start date: 2024-05-17
• Primary completion: 2024-12-17
• Completion: 2025-04-11
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: Spain