Clinical trial · Observational
Impact of Perioperative Hyperoxia on Cancer Recurrence and Mortality After Elective Colorectal Cancer Surgery
NCT06989346CI-TRIAL-00090140OncO2completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Surgery | — | UNRESOLVED | — |
| Hyperoxia | — | UNRESOLVED | — |
| Mortality | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
| Survival Rate | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Hyperoxia
- description
- Perioperative hyperoxia (FiO₂ \> 0.8)
- label
- Control
- description
- Conventional perioperative oxygen therapy (FiO₂ \< 0.4)
Primary outcomes (1)
- measure
- Recurrence-free Survival
- timeFrame
- Follow-up period (at least 3 years since surgery)
- description
- 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)
- measure
- Mortality
- timeFrame
- 3-year follow-up period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDSadurni 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. PMID 36282221
- BACKGROUNDPodolyak 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. PMID 27195634
- BACKGROUNDMeyhoff 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. PMID 24860156