An observational study in Recurrence, Survival Rate and Mortality, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Parc de Salut Mar · Observational
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.
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.
115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.
This study's enrollment of 403 is above the median of 104 across 32 observational studies indexed under Hyperoxia.
Browse Hyperoxia studies →Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 25 are open to participants now.
Compared within Hyperoxia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patient diagnosed with colorectal cancer, eligible for a scheduled colorectal surgery with a curative intention
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Perioperative hyperoxia (FiO₂ \> 0.8)
Conventional perioperative oxygen therapy (FiO₂ \< 0.4)
Recurrence-free Survival
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
Time frame: Follow-up period (at least 3 years since surgery)
Mortality
Percentage of global mortality (not exclusively related to the oncologic disease)
Time frame: 3-year follow-up period
Plan to share: Undecided — We need to pursue additional conversations with our organization to request to share IPD.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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