The Efficacy of External Warming During Laparoscopic Bariatric Surgery

NCT ID: NCT03429205

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2022-11-21

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia Morbid Obesity Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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No heating - Study group

Patient will undergo bariatric surgery without utilization of external heating device.

Group Type EXPERIMENTAL

No external heating used during surgery

Intervention Type OTHER

Deviation from external heating for all surgery standard

Heating - Control group

Patient will undergo bariatric surgery with utilization of external heating device.

Group Type OTHER

External heating blanket used during surgery

Intervention Type OTHER

Standard external heating plan used in all surgery types

Interventions

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No external heating used during surgery

Deviation from external heating for all surgery standard

Intervention Type OTHER

External heating blanket used during surgery

Standard external heating plan used in all surgery types

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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David Goitein MD

Director, Bariatric and Metabolic Surgery, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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4578-17-SMC

Identifier Type: -

Identifier Source: org_study_id

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