Bariatric Surgery Candidate, Hypothermia, Morbid Obesity
Conditions
Keywords
Sleeve gastrectomy, Roux-Y gastric bypass, Single anastomosis gastric bypass, Hypothermia, External heating blanket
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.
Interventions
OTHERNo external heating used during surgery
Deviation from external heating for all surgery standard
OTHERExternal heating blanket used during surgery
Standard external heating plan used in all surgery types
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Outcome results
None listed