The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 21, 2022

Interventions

  • Other: No external heating used during surgery
    • Deviation from external heating for all surgery standard
  • Other: External heating blanket used during surgery
    • Standard external heating plan used in all surgery types

Arms, Groups and Cohorts

  • Experimental: No heating – Study group
    • Patient will undergo bariatric surgery without utilization of external heating device.
  • Other: Heating – Control group
    • Patient will undergo bariatric surgery with utilization of external heating device.

Clinical Trial Outcome Measures

Primary Measures

  • Intraoperative core-temperature decline
    • Time Frame: Surgery duration, up to 2 hours from surgery start-time
    • Core-temperature will be continuously measured throughout surgery
  • Arrival temperature at post anesthesia care unit (PACU)
    • Time Frame: arrival to recovery room, up to 2 h from surgery start-time
    • Core temperature upon arrival to recovery room

Secondary Measures

  • Hypothermia events
    • Time Frame: 3 hours from surgery start-time
    • Measurement of core temperature <35 C
  • Intraoperative blood loss
    • Time Frame: Surgery duration, up to 2 hours from surgery start-time
    • Intraoperative bleeding score will be used
  • Post operative complications
    • Time Frame: 30 days postoperatively
    • Complications after surgery (30 days), graded according to Clavien-Dindo classification

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Goitein MD, Director, Bariatric and Metabolic Surgery, Principal Investigator – Sheba Medical Center

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