Preoperative Hyperthermia in Major Abdominal Surgery Patients

Phase 1

Completed

• Conditions: Colon Cancer

• Registration Number: NCT00876954
• Lead Sponsor: Medical University of Vienna

Brief Summary

The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Detailed Description

The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2010-10
• Study Completion: 2011-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male and female patients, age 18 - 75
• Open abdominal, curative cancer surgery > 2 h

Exclusion Criteria

• Pregnancy
• Chronic cortisone treatment
• Ongoing chemotherapy
• Acute infections, septic surgery
• Palliative surgery (e.g. debulking only)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immune Status	24 hours after surgery	LPS induced TNF-alpha

Trial Locations

Locations (1)

Oliver Kimberger M.D.; 🇦🇹 Vienna, Austria