Effects of Oxygen After Abdominal Oncological Surgery

Not Applicable

Completed

• Conditions: Abdominal Cancer
• Interventions: Procedure: Oxygen

• Registration Number: NCT06321874
• Lead Sponsor: Jules Bordet Institute

Brief Summary

The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery

Detailed Description

For anemia treatment in cancer patients, human recombinant erythropoietin is often used. However, its application is constrained due to high costs, side effects, and limited availability in some regions. This research and clinical exploration aim to identify an tool alternative to transfusion.

Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff.

Pre-surgery, all patients were administered an oral benzodiazepine. General anesthesia was employed, potentially combined with epidural techniques and standard anesthesia monitors were used. The choice of anesthesia technique was at the discretion of the anesthetist. During surgery, patients received 40-50% FiO2 ventilation and were extubated at the surgery's end. Post-surgery, patients were admitted to the ICU for at least 24 hours, receiving oxygen if saturation dropped below 98%. The oxygen protocol commenced 24 hours after ICU admission (day 1). The transfusion threshold was set at 8 g/dl with clinical signs.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2011-11-01
• Study Completion: 2011-11-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• patients undergoing abdominal oncological surgery

Exclusion Criteria

• GFR<60 ml/minute and/ or creatinine serum level > 2mg/dl
• Transfusion of red blood cells per or postoperatively
• Bleeding requiring repeated transfusions during or after surgery
• Severe respiratory syndrome necessitating continuous oxygen
• Intolerance to oxygen mask

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normobaric Oxygen Paradox (NOP) group	Oxygen	The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask.

Primary Outcome Measures

Name	Time	Method
Percentage change in reticulocyte count	6 days	Percentage change in reticulocyte count from baseline to day six within each group

Secondary Outcome Measures

Name	Time	Method
haemoglobin levels mesure	6 days	haemoglobin levels mesured at baseline and on day six
haematocrit levels mesure	6 days	haematocrit levels mesured at baseline and on day six

Trial Locations

Locations (1)

Khalife Maher; 🇧🇪 Brussels, Belgium