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OpenTrials
Completed

NCT Number: NCT06989346

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years old;
  • Scheduled for major elective colorectal surgery under general anaesthesia with tracheal intubation.

Exclusion criteria

  • Non-oncologic surgery or non-curative oncological surgery
  • Pregnant or breastfeeding women
  • Chronic obstructive pulmonary disease (forced expiratory volume in one second <50% or in need of domiciliary oxygen thera-py)
  • Acute coronary event or stroke during the previous six weeks (before the surgery)
  • Chronic renal failure requiring renal replacement therapy;
  • Predicted length of stay of less than one day;
  • Any patient that has received general anaesthesia during the previous month.

Treatment and study plan

Primary outcomes

  1. Recurrence-free Survival

    Time frame: Follow-up period (at least 3 years since surgery)

    Length of time from the end of primary treatment (surgery in this case) until the evidence of cancer recurrence (locoregional or systemic) or death in the last follow-up

Secondary outcomes

  1. Mortality

    Time frame: 3-year follow-up period

    Percentage of global mortality (not exclusively related to the oncologic disease)

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Acronym: OncO2

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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