Preoperative Hyperthermia in Major Abdominal Surgery Patients

Medical University of Vienna

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colon Cancer

Treatments: Procedure: Normothermia; Procedure: Hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT00876954

PreopHypertherm1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Warming without increase in core temperature

Treatment:

Procedure: Normothermia

Hyperthermia

Active Comparator group

Description:

Hyperthermia for 2,5 hours (39 °C core temperature)

Treatment:

Procedure: Hyperthermia