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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-17

Study Completion Date

2025-04-11

Brief Summary

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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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Detailed Description

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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

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Recurrence Survival Rate Mortality Colorectal Surgery Hyperoxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hyperoxia

Perioperative hyperoxia (FiO₂ \> 0.8)

No interventions assigned to this group

Control

Conventional perioperative oxygen therapy (FiO₂ \< 0.4)

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No