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NCT Number: NCT01723280

Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)

Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up.

Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients.

At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.

Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.

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Key information

Conditions

Laparotomy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet

Copenhagen, DK-2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypical or neoplastic cells).

Exclusion criteria

  • Other surgery within 30 days (except surgery in local anaesthesia).
  • Chemotherapy within 3 months.
  • Inability to give informed consent.
  • Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).

Treatment and study plan

Oxygen

Drug

During and 2 hrs after surgery

Primary outcomes

  1. Frequency of patients with the composite outcome measure of either a subsequent, new or recurrent, cancer registration or a new histological specimen showing any neoplasm

    Time frame: 36-60 months after randomization

Secondary outcomes

  1. Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry

    Time frame: 15-39 months after randomization

  2. Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm

    Time frame: 36-60 months after randomization

  3. Frequency of patients with new histological specimen in the Danish Patobank showing neoplasm of a histological type not previously diagnosed

    Time frame: 36-60 months after randomization

  4. Frequency of patients with cancer as diagnosis code at a readmission

    Time frame: 36-60 months after randomization

  5. Frequency of patients with cancer as primary diagnosis code at a readmission

    Time frame: 36-60 months after randomization

  6. Duration of cancer-free survival, as assessed by Kaplan-Meier statistics

    Time frame: 36-60 months after randomization

Other outcomes

  1. Type of new cancer registration

    Time frame: 15-39 months after randomization

  2. Histological type of new cancer specimen

    Time frame: 36-60 months after randomization

  3. Cause of death

    Time frame: 15-39 months after randomization

Sponsors and collaborators

Lead sponsor

Lars S. Rasmussen

Other

Registry information

Official study title

Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)

Acronym: PROXI

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Nov 7, 2012
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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