The Efficacy of External Warming During Laparoscopic Bariatric Surgery

Not Applicable

Terminated

• Conditions: Bariatric Surgery Candidate; Morbid Obesity; Hypothermia
• Interventions: Other: No external heating used during surgery; Other: External heating blanket used during surgery

• Registration Number: NCT03429205
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-04
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Study Start: 2018-03-15
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No heating - Study group	No external heating used during surgery	Patient will undergo bariatric surgery without utilization of external heating device.
Heating - Control group	External heating blanket used during surgery	Patient will undergo bariatric surgery with utilization of external heating device.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel