The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Sponsor

Sheba Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03429205

Collaborator

(none)

100

Enrollment

Location

Arms

68.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia Morbid Obesity Bariatric Surgery Candidate	Other: No external heating used during surgery Other: External heating blanket used during surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Actual Study Start Date :

Mar 15, 2018

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intraoperative core-temperature decline [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) [arrival to recovery room, up to 2 h from surgery start-time]
Core temperature upon arrival to recovery room

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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