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Preoperative Hyperthermia in Major Abdominal Surgery Patients

Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00876954
Enrollment
20
Registered
2009-04-07
Start date
2009-04-30
Completion date
2011-07-31
Last updated
2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

PROCEDURENormothermia

Warming without increase in core temperature

PROCEDUREHyperthermia

Core hyperthermia (39 °C) for 2,5 hours

Sponsors

Braun Stiftung
CollaboratorUNKNOWN
Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Immune Status24 hours after surgeryLPS induced TNF-alpha

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026