Impact of Perioperative Hyperoxia on Cancer Recurrence an... | NCT06989346

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

NCT06989346

Sponsor

Parc de Salut Mar

Status

Completed

Last Update Posted

May 25, 2025Actual

Enrollment

403Actual

Phase

Not provided

Conditions

Recurrence
Survival Rate
Mortality
Colorectal Surgery
Hyperoxia

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2024Actual

Primary Completion Date

Dec 17, 2024Actual

Completion Date

Apr 11, 2025Actual

First Submitted Date

May 17, 2025

First Submission Date that Met QC Criteria

May 17, 2025

First Posted Date

May 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2025

Last Update Posted Date

May 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

403Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperoxia		Perioperative hyperoxia (FiO₂ > 0.8)
Control		Conventional perioperative oxygen therapy (FiO₂ < 0.4)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mortality	Percentage of global mortality (not exclusively related to the oncologic disease)	3-year follow-up period

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Sadurní, MD	Hospital del Mar	Principal Investigator
Laura Castelltort, MD	Hospital del Mar	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital del Mar		Barcelona	Catalonia	08003	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36282221	Background	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.
27195634	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012818	Signs and Symptoms, Respiratory