<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723280</url>
  </required_header>
  <id_info>
    <org_study_id>2006-001710-32-follow-up</org_study_id>
    <secondary_id>GCP-2006-101</secondary_id>
    <secondary_id>KF 02 306766</secondary_id>
    <nct_id>NCT01723280</nct_id>
  </id_info>
  <brief_title>Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)</brief_title>
  <acronym>PROXI</acronym>
  <official_title>Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lars S. Rasmussen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and&#xD;
      after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis&#xD;
      at a long-term follow-up.&#xD;
&#xD;
      Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of&#xD;
      surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI&#xD;
      trial, found no difference in frequency of surgical site infection. In fact, long-term&#xD;
      mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80%&#xD;
      oxygen, and this appeared to be statistically significant in patients undergoing cancer&#xD;
      surgery, but not in non-cancer patients.&#xD;
&#xD;
      At this point, no convincing mechanism explains the observed increased mortality after&#xD;
      hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.&#xD;
&#xD;
      Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the&#xD;
      frequency of patients with a subsequent, new or recurrent, cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry</measure>
    <time_frame>15-39 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with new histological specimen in the Danish Patobank showing neoplasm of a histological type not previously diagnosed</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with cancer as diagnosis code at a readmission</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with cancer as primary diagnosis code at a readmission</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of cancer-free survival, as assessed by Kaplan-Meier statistics</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Type of new cancer registration</measure>
    <time_frame>15-39 months after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Histological type of new cancer specimen</measure>
    <time_frame>36-60 months after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cause of death</measure>
    <time_frame>15-39 months after randomization</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1386</enrollment>
  <condition>Laparotomy</condition>
  <arm_group>
    <arm_group_label>80% oxygen group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>30% oxygen group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>During and 2 hrs after surgery</description>
    <arm_group_label>30% oxygen group</arm_group_label>
    <arm_group_label>80% oxygen group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in the PROXI trial&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is&#xD;
             suspected (defined as risk of ovarian malignancy index &gt;200 or a specimen with&#xD;
             atypical or neoplastic cells).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other surgery within 30 days (except surgery in local anaesthesia).&#xD;
&#xD;
          -  Chemotherapy within 3 months.&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
&#xD;
          -  Inability to keep oxygen saturation above 90% without supplemental oxygen (measured&#xD;
             preoperatively by pulse oximetry).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian S Meyhoff, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Anesthesia, HOC, Copenhagen University Hospital, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>18945347</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19826023</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Lars S. Rasmussen</investigator_full_name>
    <investigator_title>Professor, MD, PhD, DMSc</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723280
org study id: 2006-001710-32-follow-up
secondary id: GCP-2006-101
secondary id: KF 02 306766
nct id: NCT01723280
lead sponsor: 
has dmc: No
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.
observational model: Case-Control
time perspective: Prospective
measure: 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
time frame: 36-60 months after randomization
measure: Frequency of patients with subsequent, new or recurrent, cancer registration at the Danish Cancer Registry
time frame: 15-39 months after randomization
measure: Frequency of patients with new histological specimen in the Danish Patobank showing any neoplasm
time frame: 36-60 months after randomization
measure: Frequency of patients with new histological specimen in the Danish Patobank showing neoplasm of a histological type not previously diagnosed
time frame: 36-60 months after randomization
measure: Frequency of patients with cancer as diagnosis code at a readmission
time frame: 36-60 months after randomization
measure: Frequency of patients with cancer as primary diagnosis code at a readmission
time frame: 36-60 months after randomization
measure: Duration of cancer-free survival, as assessed by Kaplan-Meier statistics
time frame: 36-60 months after randomization
measure: Type of new cancer registration
time frame: 15-39 months after randomization
measure: Histological type of new cancer specimen
time frame: 36-60 months after randomization
measure: Cause of death
time frame: 15-39 months after randomization
arm group label: 80% oxygen group
arm group label: 30% oxygen group
intervention type: Drug
intervention name: Oxygen
description: During and 2 hrs after surgery
arm group label: 30% oxygen group
arm group label: 80% oxygen group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian S Meyhoff, MD, PhD
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
citation: 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
citation: 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
responsible party type: Sponsor-Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Lars S. Rasmussen
investigator title: Professor, MD, PhD, DMSc