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

NCT01723280 | Completed

• 3 other identifiers: 2006-001710-32-follow-upGCP-2006-101KF 02 306766
• Study Type: observational
• Target: 1,386
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparotomy

Outcome Measures

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

  36-60 months after randomization

Secondary Outcomes (6)

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

  15-39 months after randomization

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

  36-60 months after randomization

• 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

• Frequency of patients with cancer as diagnosis code at a readmission

  36-60 months after randomization

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

  36-60 months after randomization

Other Outcomes (3)

• Type of new cancer registration

  15-39 months after randomization

• Histological type of new cancer specimen

  36-60 months after randomization

• Cause of death

  15-39 months after randomization

Study Arms (2)

80% oxygen group

Drug: Oxygen

30% oxygen group

Drug: Oxygen

Interventions

Oxygen DRUG

During and 2 hrs after surgery

30% oxygen group; 80% oxygen group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the PROXI trial

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lars S. Rasmussen: lead

Study Sites (1)

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

Copenhagen, DK-2100, Denmark

Location

Related Publications (3)

• Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Helto 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.

  PMID: 18945347 BACKGROUND

• Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall 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, Helto 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.

  PMID: 19826023 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 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Christian S Meyhoff, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD, DMSc

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: October 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2012
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

DK (1)