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The Efficacy of External Warming During Laparoscopic Bariatric Surgery

S

Sheba Medical Center

Status

Terminated

Conditions

Bariatric Surgery Candidate
Morbid Obesity
Hypothermia

Treatments

Other: External heating blanket used during surgery
Other: No external heating used during surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03429205
4578-17-SMC

Details and patient eligibility

About

External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.

The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.

The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last <2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Eligible for bariatric surgery
  • Surgery time estimated to be < 2 hours

Exclusion criteria

  • Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
  • Surgery time estimated to be more than 2 hours

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

No heating - Study group
Experimental group
Description:
Patient will undergo bariatric surgery without utilization of external heating device.
Treatment:
Other: No external heating used during surgery
Heating - Control group
Other group
Description:
Patient will undergo bariatric surgery with utilization of external heating device.
Treatment:
Other: External heating blanket used during surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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