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

Phase 4

Completed

• Conditions: Laparotomy
• Interventions: Drug: Oxygen

• Registration Number: NCT00364741
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-15
• Study First Submitted QC: 2006-08-15
• Study First Posted: 2006-08-16
• Study Start: 2006-10
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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).

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Oxygen	FiO2 = 0.80
A	Oxygen	Fraction of inspired oxygen (FiO2) = 0.30

Primary Outcome Measures

Name	Time	Method
Surgical wound infection	14 days after surgery

Secondary Outcome Measures

Name	Time	Method
Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit.	30 days after surgery

Trial Locations

Locations (14)

Copenhagen University Hospital, Bispebjerg; 🇩🇰 Copenhagen, 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, Denmark

Aarhus Sygehus; 🇩🇰 Aarhus, Denmark

Copenhagen University Hospital, Gentofte; 🇩🇰 Hellerup, Denmark

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Holbaek Hospital; 🇩🇰 Holbaek, Denmark

Copenhagen University Hospital, Amager; 🇩🇰 Copenhagen, Denmark

Copenhagen University Hospital, Herlev; 🇩🇰 Herlev, Denmark