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

Laparotomy Clinical Trial

— PROXI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723280
• Other study ID #: 2006-001710-32-follow-up
• Secondary ID: GCP-2006-101KF 0
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 5, 2012
• Start date: October 2006
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1386
• Est. completion date: November 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laparotomy

Intervention

Drug:
• Oxygen
During and 2 hrs after surgery

Locations

Country	Name	City	State
Denmark	Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Lars S. Rasmussen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Høgdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Heltø K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452. — View Citation

Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Heltø K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial. Trials. 2008 Oct 22;9:58. doi: 10.1186/1745-6215-9-58. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type of new cancer registration		15-39 months after randomization	No
Other	Histological type of new cancer specimen		36-60 months after randomization	No
Other	Cause of death		15-39 months after randomization	No
Primary	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		36-60 months after randomization	No
Secondary	Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry		15-39 months after randomization	No
Secondary	Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm		36-60 months after randomization	No
Secondary	Frequency of patients with new histological specimen in the Danish Patobank showing neoplasm of a histological type not previously diagnosed		36-60 months after randomization	No
Secondary	Frequency of patients with cancer as diagnosis code at a readmission		36-60 months after randomization	No
Secondary	Frequency of patients with cancer as primary diagnosis code at a readmission		36-60 months after randomization	No
Secondary	Duration of cancer-free survival, as assessed by Kaplan-Meier statistics		36-60 months after randomization	No