Clinical trial NCT06989346: Impact of Perioperative Hyperoxia on Cancer Recurrence and Mortality After Elective Colorectal Cancer Surgery
Official title: Impact of Perioperative Hyperoxia on Cancer Recurrence and Mortality After Elective Colorectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrence
Survival Rate
Mortality
Colorectal Surgery
Hyperoxia
Keywords: Hyperoxia
Recurrence-free Survival
Colorectal Surgery
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed with colorectal cancer, eligible for a scheduled colorectal surgery with a curative intention

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free Survival
timeFrame: Follow-up period (at least 3 years since surgery)
Secondary outcomes:
measure: Mortality
timeFrame: 3-year follow-up period
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
Study officials:
affiliation: Hospital del Mar
name: Marc Sadurní, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Laura Castelltort, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Podolyak 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.
citation: Meyhoff 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.