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

• Sponsor: Lars S. Rasmussen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01723280
• Collaborator: (none)
• Enrollment: 1,386
• Location: 1
• Duration (Months): 73
• Patients Per Site Per Month: 19

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparotomy	Drug: Oxygen

Study Design

• Study Type: Observational
• Actual Enrollment: 1386 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
80% oxygen group	Drug: Oxygen; During and 2 hrs after surgery
30% oxygen group	Drug: Oxygen; During and 2 hrs after surgery

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry [15-39 months after randomization]

2. Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm [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 [36-60 months after randomization]

4. Frequency of patients with cancer as diagnosis code at a readmission [36-60 months after randomization]

5. Frequency of patients with cancer as primary diagnosis code at a readmission [36-60 months after randomization]

6. Duration of cancer-free survival, as assessed by Kaplan-Meier statistics [36-60 months after randomization]

Other Outcome Measures

1. Type of new cancer registration [15-39 months after randomization]

2. Histological type of new cancer specimen [36-60 months after randomization]

3. Cause of death [15-39 months after randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet	Copenhagen		Denmark	DK-2100

Sponsors and Collaborators

• Lars S. Rasmussen

Investigators

• Principal Investigator: Christian S Meyhoff, MD, PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Lars S. Rasmussen, Professor, MD, PhD, DMSc, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT01723280
• Other Study ID Numbers: 2006-001710-32-follow-up; GCP-2006-101; KF 02 306766
• First Posted: Nov 7, 2012
• Last Update Posted: Nov 7, 2012
• Last Verified: Nov 1, 2012

Study Results

No Results Posted as of Nov 7, 2012