The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03429205
• Other study ID #: 4578-17-SMC
• Status: Terminated
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: November 21, 2022

Study information

• Verified date: April 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Hypothermia
• Morbid Obesity
• Obesity, Morbid

Intervention

Other:
• No external heating used during surgery
Deviation from external heating for all surgery standard
• External heating blanket used during surgery
Standard external heating plan used in all surgery types

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative core-temperature decline	Core-temperature will be continuously measured throughout surgery	Surgery duration, up to 2 hours from surgery start-time
Primary	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	Hypothermia events	Measurement of core temperature <35 C	3 hours from surgery start-time
Secondary	Intraoperative blood loss	Intraoperative bleeding score will be used	Surgery duration, up to 2 hours from surgery start-time
Secondary	Post operative complications	Complications after surgery (30 days), graded according to Clavien-Dindo classification	30 days postoperatively