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

NCT06989346 | Completed

• 1 other identifier: OncO2
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrence; Survival Rate; Mortality; Colorectal Surgery; Hyperoxia

Keywords

Hyperoxia; Recurrence-free Survival; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  Follow-up period (at least 3 years since surgery)

Secondary Outcomes (1)

• Mortality

  3-year follow-up period

Study Arms (2)

Hyperoxia

Perioperative hyperoxia (FiO₂ \> 0.8)

Control

Conventional perioperative oxygen therapy (FiO₂ \< 0.4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with colorectal cancer, eligible for a scheduled colorectal surgery with a curative intention

You may qualify if:

• Patients over 18 years old;
• Scheduled for major elective colorectal surgery under general anaesthesia with tracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Related Publications (3)

• 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.

  PMID: 36282221 BACKGROUND

• 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.

  PMID: 27195634 BACKGROUND

• 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.

  PMID: 24860156 BACKGROUND

MeSH Terms

Conditions

Recurrence; Hyperoxia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Marc Sadurní, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Laura Castelltort, MD

  Hospital del Mar

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 25, 2025
• Study Start: May 17, 2024
• Primary Completion: December 17, 2024
• Study Completion: April 11, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

ES (1)