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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


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
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