Preoperative Hyperthermia in Major Abdominal Surgery Patients

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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