The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Conditions
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Hypothermia, Morbid Obesity, Bariatric Surgery Candidate

Intervention / Treatment
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* Other: No external heating used during surgery
* Other: External heating blanket used during surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve gastrectomy, Roux-Y gastric bypass, Single anastomosis gastric bypass, Hypothermia, External heating blanket