Laparotomy Clinical Trial
— PROXIOfficial title:
Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)
Verified date | November 2012 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Observational |
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.
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). |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Lars S. Rasmussen |
Denmark,
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
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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