Highlights
- •The magnetic surgical system provides a safe and effective alternative for liver retraction.
- •The system can be used in patients with wide range of body mass index (BMI).
- •The magnetic surgical system reduces the need of a dedicated port for liver retraction.
Abstract
Background
Exposure of the surgical field is an essential component of minimally invasive surgery.
Liver retraction is an important element of bariatric procedures because visualization
of the stomach and gastroesophageal junction is key. The magnetic surgical system
provides a well-tolerated and effective option for adjustable liver retraction without
the use of a dedicated port.
Objective
The purpose of this study was to evaluate the safety profile and effectiveness of
the magnetic surgical system in patients undergoing bariatric procedures.
Setting
Two investigational sites in Chile.
Methods
A prospective, single-arm study (ClinicalTrials.gov NCT03508674) with adherence to Good Clinical Practices and ISO 14155:2011(E) was undertaken to
evaluate the safety profile and effectiveness of the magnetic surgical system in patients
undergoing bariatric surgery. Patient follow-up occurred at 7 and 30 days postprocedure.
Results
A total of 50 patients who met the inclusion criteria had a body mass index ranging
from 28.4 to 58.2 kg/m2. All procedures were completed without complications or conversions. The average
overall procedure time was 61 minutes, and the amount of coupling time between the
magnetic controller and the detachable grasper was 37 minutes. In all cases the device
was able to adequately retract the liver to achieve an effective exposure of the target
tissue and perform the bariatric procedure. A total of 24 adverse effects were reported
throughout the course of the study. All device-related adverse effects were mild in
severity and resolved with no clinical sequelae.
Conclusion
The magnetic surgical system is a well-tolerated and effective option for liver retraction
in minimally invasive and bariatric surgery in patients with a varying range of body
mass indexes.
Key words
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Article info
Publication history
Published online: August 26, 2020
Accepted:
August 12,
2020
Received:
January 7,
2020
Identification
Copyright
© 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
