Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)

Laparotomy Clinical Trial

Official title:

PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364741
• Other study ID #: 2006-001710-32
• Secondary ID: GCP-2006-101KF 0
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2006
• Last updated: October 15, 2009
• Start date: October 2006
• Est. completion date: November 2008

Study information

• Verified date: October 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laparotomy

Intervention

Drug:
• Oxygen
During and 2 hours after surgery

Locations

Country	Name	City	State
Denmark	Aarhus Sygehus	Aarhus
Denmark	Copenhagen University Hospital, Amager	Copenhagen
Denmark	Copenhagen University Hospital, Bispebjerg	Copenhagen
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen
Denmark	Copenhagen University Hospital, Gentofte	Hellerup
Denmark	Copenhagen University Hospital, Herlev	Herlev
Denmark	Holbaek Hospital	Holbaek
Denmark	Kolding Hospital	Kolding
Denmark	Naestved Hospital	Naestved
Denmark	Nykoebing Falster Hospital	Nykoebing Falster
Denmark	Slagelse Hospital	Slagelse
Denmark	Funen County Hospital	Svendborg
Denmark	Vejle Hospital	Vejle
Denmark	Viborg Hospital	Viborg

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Danish Medical Research Council

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, — 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
Primary	Surgical wound infection		14 days after surgery	No
Secondary	Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit.		30 days after surgery	Yes