Abstract
Background
Morbid obesity remains one of society’s significant medical dilemmas. It is rapidly worsening and expected to affect 35% of the US population by the year 2020. Common current bariatric procedures exist and include, but not limited to, the adjustable gastric band, gastric bypass, and the sleeve gastrectomy. Although beneficial to morbidly obese patients, they also alter the patient’s anatomy and involve resections, or require maintenance. The goal of the trial is to show a new minimally invasive vertical gastric clip technique that produces significant weight loss but requires no resection, no change in anatomy, and is reversible.
Methods
From November 2012 to February 2016, prospective collected data from 117 patients was included in the gastric clip trial. The clip consists of a silicone-covered titanium backbone with an inferior hinged opening that separates a medial lumen from an excluded lateral gastric pouch. The inferior opening allows the gastric juices to empty from the fundus and the body of the stomach into the distal antrum.
Results
Weight loss and comorbidities were evaluated among 117 patients over a 39-month period. 66.7% excess weight loss was seen with minimal adverse events. Average length of surgery was 69 min. Average length of stay was 1.3 days. Fifteen of the originally implanted clips were electively removed based on the original protocol, and the other two were removed for displacement of the device.
Conclusion
The vertical, gastric clip trial has shown that excellent weight loss can be achieved without some of the complications seen with historical bariatric procedures. This clip is placed without requiring stapling, resection, malabsorption, change in anatomy, or maintenance. It is also easily reversible.
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Conflict of Interest
Moises Jacobs: consultant for Ethicon Endo-Surgery and has equity in Advanced Bariatrics, L.L.C., the manufacturer of the gastric clip.
Natan Zundel: consultant for Ethicon Endo-Surgery, Medtronic, Olympus Surgical Technologies, and Apollo Endosurgery
Gustavo Plasencia: consultant for Ethicon Endo-Surgery and Intuitive Surgical, and has equity in Advanced Bariatrics.
Prospero Rodriguez-Pumarol declares no conflict of interest.
Eddie Gomez: consultant for Ethicon Endo-Surgery, Medtronic, and Apollo Endosurgery
James Leithead III declares no conflict of interest.
Ethical Approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
All applicable institutional and/or national guidelines for the care and use of animals were followed.
Informed Consent
Informed consent was obtained from all individual participants included in the study.
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Jacobs, M., Zundel, N., Plasencia, G. et al. A Vertically Placed Clip for Weight Loss: a 39-Month Pilot Study. OBES SURG 27, 1174–1181 (2017). https://doi.org/10.1007/s11695-016-2432-5
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DOI: https://doi.org/10.1007/s11695-016-2432-5
Keywords
- Vertical sleeve
- Lap band
- Reversible weight loss surgery clip
- Clamp
- Stomach stapling
- Gastric sleeve
- New surgical procedures for weight loss
- New surgical weight loss clip
- Reversible bariatric surgery
- Bariatric surgery
- Balloon
- Intragastric balloon
- Endoscopic gastroplasty
- Magenstrasse and Mill gastroplasty
- Gastric pacemaker