RecurrenceOncO2NCT06989346
Impact of Perioperative Hyperoxia on Cancer Recurrence and Mortality After Elective Colorectal Cancer Surgery
An observational study of Recurrence and Survival Rate, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrence, Survival Rate, Mortality
- How many people
- 403 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2024to 11 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient diagnosed with colorectal cancer, eligible for a scheduled colorectal surgery with a curative intention
Who may be able to join
- Patients over 18 years old;
- Scheduled for major elective colorectal surgery under general anaesthesia with tracheal intubation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Hyperoxia, Recurrence-free Survival, Colorectal Surgery
- Medical subject headings
- Recurrence, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxia | Perioperative hyperoxia (FiO₂ > 0.8) | |
| Control | Conventional perioperative oxygen therapy (FiO₂ < 0.4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Follow-up period (at least 3 years since surgery)
Secondary outcomes (1)
Mortality
Percentage of global mortality (not exclusively related to the oncologic disease)
Measured: 3-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start17 May 2024
- Primary completion17 Dec 2024
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Sadurní, MD, Principal investigator, Hospital del MarLaura Castelltort, MD, Study director, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989346
- Sponsor's protocol ID
- OncO2
- Acronym
- OncO2
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We need to pursue additional conversations with our organization to request to share IPD.
Publications
Sadurni M, Castelltort L, Rivera P, Gallart L, Pascual M, Duran X, Grocott MP. Perioperative hyperoxia and myocardial injury after surgery: a randomized controlled trial. Minerva Anestesiol. 2023 Jan-Feb;89(1-2):40-47. doi: 10.23736/S0375-9393.22.16634-4. Epub 2022 Oct 25.
PubMed 36282221Podolyak A, Sessler DI, Reiterer C, Fleischmann E, Akca O, Mascha EJ, Greif R, Kurz A. Perioperative Supplemental Oxygen Does Not Worsen Long-Term Mortality of Colorectal Surgery Patients. Anesth Analg. 2016 Jun;122(6):1907-11. doi: 10.1213/ANE.0000000000001316.
PubMed 27195634Meyhoff CS, Jorgensen LN, Wetterslev J, Siersma VD, Rasmussen LS; PROXI Trial Group. Risk of new or recurrent cancer after a high perioperative inspiratory oxygen fraction during abdominal surgery. Br J Anaesth. 2014 Jul;113 Suppl 1:i74-i81. doi: 10.1093/bja/aeu110. Epub 2014 May 23.
PubMed 24860156
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Hyperoxia on Cancer Recurrence and Mortality After Elective Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06989346
- Acronym / sponsor ID
- OncO2 / OncO2
- Conditions
- Recurrence, Survival Rate, Mortality, Colorectal Surgery, Hyperoxia
- Keywords
- Hyperoxia, Recurrence-free Survival, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia | – | –Perioperative hyperoxia (FiO₂ > 0.8) |
| Control | – | –Conventional perioperative oxygen therapy (FiO₂ < 0.4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with colorectal cancer, eligible for a scheduled colorectal surgery with a curative intention
Key inclusion criteria (2 listed)
- Patients over 18 years old;
- Scheduled for major elective colorectal surgery under general anaesthesia with tracheal intubation.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Mortality
Time frame: 3-year follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 36282221Sadurni M, Castelltort L, Rivera P, Gallart L, Pascual M, Duran X, Grocott MP. Perioperative hyperoxia and myocardial injury after surgery: a randomized controlled trial. Minerva Anestesiol. 2023 Jan-Feb;89(1-2):40-47. doi: 10.23736/S0375-9393.22.16634-4. Epub 2022 Oct 25.
- Background: PubMed 27195634Podolyak A, Sessler DI, Reiterer C, Fleischmann E, Akca O, Mascha EJ, Greif R, Kurz A. Perioperative Supplemental Oxygen Does Not Worsen Long-Term Mortality of Colorectal Surgery Patients. Anesth Analg. 2016 Jun;122(6):1907-11. doi: 10.1213/ANE.0000000000001316.
- Background: PubMed 24860156Meyhoff CS, Jorgensen LN, Wetterslev J, Siersma VD, Rasmussen LS; PROXI Trial Group. Risk of new or recurrent cancer after a high perioperative inspiratory oxygen fraction during abdominal surgery. Br J Anaesth. 2014 Jul;113 Suppl 1:i74-i81. doi: 10.1093/bja/aeu110. Epub 2014 May 23.
- Individual participant dataSharing planned: Undecided. We need to pursue additional conversations with our organization to request to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Sadurní, MD principal investigator
Hospital del Mar
Laura Castelltort, MD study director
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrence and Survival Rate, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (time frame: Follow-up period (at least 3 years since surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.