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Multicenter Randomized Study of Obesity Treatment with Minimally Invasive Injection of Hyaluronic Acid Versus and Combined with Intragastric Balloon

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Abstract

Background

Research into minimally invasive techniques is worthwhile for greater acceptance in bariatric surgery, a useful first step being to evaluate the combination of these with current procedures. We suggest that intragastric balloon (IGB) can be performed with hyaluronic acid (HA) injections at the level of the gastroesophageal junction.

Methods

A submucosal restriction is created by circular injection of an absorbable material within a defined area based on endoscopic anatomy. We included 101 patients in a prospective multicenter randomized trial, with average body mass index (BMI) 33.4 (range 27–44), treated from April 2010 to April 2012 by IGB and/or HA injection, sequentially, and followed for two more years. Patients were divided into group 1 (IGB alone), group 2 (IGB followed by HA at IGB removal, at 6 months), and group 3 (HA and IGB at 6 months).

Results

BMI loss at 6 months was inferior in the HA group (32 patients) compared with the IGB groups (68 patients) (2.1 ± 0.4 versus 3.4 ± 0.3, p < 0.05). The efficacy of IGB alone compared with combined treatments (groups 2 and 3) was significantly inferior at 18 months only, but the impact of the treatment sequence (HA before or after IGB) on BMI loss was not statistically significant, although in favor of HA first.

Conclusions

This study did not demonstrate the efficacy of HA injections as an obesity treatment.

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Ethical Approval

All procedures performed in the 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.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Conflict of Interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Polyclinique Lyon-Nord, 941 Rue Capitaine Julien, 69140, Rillieux-la-Pape, France

    Jerome Dargent, Frédéric Pontette & Stéphane Angella

  2. Hôpital E. Herriot, 69437, Lyon, France

    François Mion, René Ecochard & Valentin Mion

  3. Clinique du Trocadéro, 75016, Paris, France

    Vianna Costil

Authors
  1. Jerome Dargent
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  2. François Mion
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  3. Vianna Costil
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  4. René Ecochard
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  5. Frédéric Pontette
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  6. Valentin Mion
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  7. Stéphane Angella
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Correspondence to Jerome Dargent.

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Dargent, J., Mion, F., Costil, V. et al. Multicenter Randomized Study of Obesity Treatment with Minimally Invasive Injection of Hyaluronic Acid Versus and Combined with Intragastric Balloon. OBES SURG 25, 1842–1847 (2015). https://doi.org/10.1007/s11695-015-1648-0

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  • DOI: https://doi.org/10.1007/s11695-015-1648-0

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