A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
NCT ID: NCT03896061
Last Updated: 2020-06-24
Study Results
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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COMPLETED
62 participants
OBSERVATIONAL
2019-04-15
2019-12-31
Brief Summary
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Detailed Description
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Data collected for the study consists of videography imaging and audio. Video recordings (no subject identifiers) will involve the use of two cameras providing:
1. Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and
2. Audio of the procedure to record the motor noise of the device while firing (audio will help identify the surgeon's pulsing technique during the procedure).
Surgeon satisfaction with transection technique will also be collected. Videography will be evaluated for staple line hemostasis and need for surgical intervention at the staple line (defined in Criteria for Evaluation).
Conditions
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Study Design
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OTHER
OTHER
Interventions
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Laparoscopic sleeve procedures
Laparoscopic sleeve procedures with powered stapler
Eligibility Criteria
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Inclusion Criteria
* Scheduled for a laparoscopic sleeve gastrectomy procedure.
Exclusion Criteria
* Other staple line reinforcement
ALL
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Locations
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Surgical Specialists of Louisiana
Metairie, Louisiana, United States
State University of New York at Buffalo
Buffalo, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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ESC-2018-01
Identifier Type: -
Identifier Source: org_study_id
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