Back to resultsThe Efficacy of External Warming During Laparoscopic Bariatric Surgery
Primary Purpose
Hypothermia, Morbid Obesity, Bariatric Surgery Candidate
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
No external heating used during surgery
External heating blanket used during surgery
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia focused on measuring Sleeve gastrectomy, Roux-Y gastric bypass, Single anastomosis gastric bypass, Hypothermia, External heating blanket
Eligibility Criteria
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
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
No heating - Study group
Heating - Control group
Arm Description
Patient will undergo bariatric surgery without utilization of external heating device.
Patient will undergo bariatric surgery with utilization of external heating device.
Outcomes
Primary Outcome Measures
Intraoperative core-temperature decline
Core-temperature will be continuously measured throughout surgery
Arrival temperature at post anesthesia care unit (PACU)
Core temperature upon arrival to recovery room
Secondary Outcome Measures
Hypothermia events
Measurement of core temperature <35 C
Intraoperative blood loss
Intraoperative bleeding score will be used
Post operative complications
Complications after surgery (30 days), graded according to Clavien-Dindo classification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429205
Brief Title
The Efficacy of External Warming During Laparoscopic Bariatric Surgery
Official Title
The Efficacy of External Warming During Laparoscopic Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruiting pace too slow.
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Morbid Obesity, Bariatric Surgery Candidate
Keywords
Sleeve gastrectomy, Roux-Y gastric bypass, Single anastomosis gastric bypass, Hypothermia, External heating blanket
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No heating - Study group
Arm Type
Experimental
Arm Description
Patient will undergo bariatric surgery without utilization of external heating device.
Arm Title
Heating - Control group
Arm Type
Other
Arm Description
Patient will undergo bariatric surgery with utilization of external heating device.
Intervention Type
Other
Intervention Name(s)
No external heating used during surgery
Intervention Description
Deviation from external heating for all surgery standard
Intervention Type
Other
Intervention Name(s)
External heating blanket used during surgery
Intervention Description
Standard external heating plan used in all surgery types
Primary Outcome Measure Information:
Title
Intraoperative core-temperature decline
Description
Core-temperature will be continuously measured throughout surgery
Time Frame
Surgery duration, up to 2 hours from surgery start-time
Title
Arrival temperature at post anesthesia care unit (PACU)
Description
Core temperature upon arrival to recovery room
Time Frame
arrival to recovery room, up to 2 h from surgery start-time
Secondary Outcome Measure Information:
Title
Hypothermia events
Description
Measurement of core temperature <35 C
Time Frame
3 hours from surgery start-time
Title
Intraoperative blood loss
Description
Intraoperative bleeding score will be used
Time Frame
Surgery duration, up to 2 hours from surgery start-time
Title
Post operative complications
Description
Complications after surgery (30 days), graded according to Clavien-Dindo classification
Time Frame
30 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
56261
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of External Warming During Laparoscopic Bariatric Surgery
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