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Recruiting pace too slow.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No heating - Study group | Experimental | Patient will undergo bariatric surgery without utilization of external heating device. |
|
| Heating - Control group | Other | Patient will undergo bariatric surgery with utilization of external heating device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No external heating used during surgery | Other | Deviation from external heating for all surgery standard |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | 56261 | Israel |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009765 | Obesity |
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| External heating blanket used during surgery | Other | Standard external heating plan used in all surgery types |
|
| 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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |