The Efficacy of External Warming During Laparoscopic Bariatric Surgery

April 14, 2023 updated by: David Goitein MD, Sheba Medical Center

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 56261
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No heating - Study group
Patient will undergo bariatric surgery without utilization of external heating device.
Other: No external heating used during surgery
Deviation from external heating for all surgery standard
Other: Heating - Control group
Patient will undergo bariatric surgery with utilization of external heating device.
Other: External heating blanket used during surgery
Standard external heating plan used in all surgery types

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative core-temperature decline
Time Frame: Surgery duration, up to 2 hours from surgery start-time
Core-temperature will be continuously measured throughout surgery
Surgery duration, up to 2 hours from surgery start-time
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
arrival to recovery room, up to 2 h from surgery start-time

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4578-17-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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