Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Laparotomy
Both
Laparotomy
Trial Information
Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
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).
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
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
Outcome Time Frame:
36-60 months after randomization
Safety Issue:
No
Principal Investigator
Christian S Meyhoff, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rigshospitalet, Denmark
Authority:
Denmark: National Board of Health
Study ID:
2006-001710-32-follow-up
NCT ID:
NCT01723280
Start Date:
October 2006
Completion Date:
November 2012
Related Keywords:
- Laparotomy
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