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Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation

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Abstract

Objective

To determine possible preoperative predictors for obtaining clinically meaningful weight loss with gastric electrical stimulation (GES) using the “Three-Factor Eating Questionnaire” (TFEQ) as well as epidemiological data.

Methods

Ninety-seven obese participants in a prospective multicenter randomized study conducted in nine European centers were implanted laparoscopically with the abiliti® closed-loop GES system (CLGES). Five clinical variables and three preoperative TFEQ factor scores (F1—cognitive-restraint, F2—disinhibition, and F3—hunger) were analyzed in order to determine predictors of weight loss success defined as excess weight loss (EWL) > 30% and failure defined as EWL < 20% at 12 months post-surgery.

Results

The mean 12-month %EWL with CLGES was 35.1 ± 19.7%, with a success rate of 52% and a failure rate of 19%. Significant predictors of success were body mass index (BMI) < 40 kg/m2 and age ≥ 50 years, increasing probability of success by 22 and 29%, respectively. A low F1—cognitive-restraint score was a significant predictor of failure (p = 0.004). The best predictive model for success included F1—cognitive-restraint, F2—disinhibition, BMI < 40, and age ≥ 50 (p = 0.002).

Conclusion

This retrospective analysis has shown that age, preoperative BMI, and F1—cognitive-restraint and F2—disinhibition scores from a preoperatively administered TFEQ are predictive of weight loss outcomes with CLGES and may be used for patient selection.

Trial Registration

ClinicalTrials.gov Identifier: NCT01448785.

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Acknowledgments

We would like to acknowledge the following investigators and site personnel who participated in the study: principal investigator: Thomas Horbach, MD, Stadtkrankenhaus Schwabach, Schwabach, Germany. Co-investigators: Spain: Salvador Morales Conde, MD and Isaías Alarcón del Agua, MD, Hospital Virgen del Rocio, Sevilla; Antonio José Torres, MD, Andrés Sanchez Pernaute, MD, and Miguel A. Rubio, MD, Complutense University of Madrid Hospital Clinico “San Carlos”, Madrid; Antonio José Torres, Fernando Lapuente, Felipe Acedo, and Antonio Picardo, Hospital Universitario Madrid Monteprincipe, Madrid. Germany: Günther Meyer, MD, Wolfart Klinik Adipositas Zentrum, München-Graefelfing; Christine Stroh, MD, SRH Wald-Klinikum Gera, Gera; Martin Susewind, MD, C Ev. Krankenhaus Hubertus, Berlin. France: Jerome Dargent, MD, Polyclinique de Rillieux, Clinique Lyon-Nord, RILLIEUX. Italy: Franco Favretti, MD, Vicenza Regional Hospital, Vicenza; Giuseppe M. Rovera, MD, San Luca Torino, Torino and Marco Anselmino, MD, University Hospital Pisa, Pisa.

The study was financially supported by the IntraPace Inc., San Jose, CA, USA. We would also like to thank sponsor personnel Rose Province for contribution to content and language editing, and Javier Sanchez for the support with data collection.

Author information

Authors and Affiliations

  1. Innovation and Minimal Invasive Surgery Unit, Virgen del Rocío, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain

    I. Alarcón del Agua, M. Socas-Macias, A. Barranco-Moreno, P. P. Garcia de Luna & S. Morales-Conde

  2. Department of Medicine – University of Padova, Center for the Study and the Integrated Management of Obesity, Clinica Medica 3 - Padova University Hospital, Via Giustiniani 2, 35128, Padova, Italy

    L. Busetto

  3. Hospital Clínico San Carlos, Calle Profesor Martín Lagos s/n, 28040, Madrid, Spain

    A. Torres-Garcia

Authors
  1. I. Alarcón del Agua
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  2. M. Socas-Macias
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  3. L. Busetto
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  4. A. Torres-Garcia
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  5. A. Barranco-Moreno
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  6. P. P. Garcia de Luna
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  7. S. Morales-Conde
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Corresponding author

Correspondence to I. Alarcón del Agua.

Ethics declarations

This study was conducted 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.

Conflict of Interest

Dr. Alarcón del Agua, Dr. Socas-Macias, Dr. Moreno-Barranco, Dr. García de Luna, and Dr. Morales-Conde have nothing to disclose. Dr. Torres-Garcia and Dr. Busetto report personal fees from IntraPace Inc., during the conduct of the study. Dr. Busetto also reports personal fees from Novo Nordisk, outside the submitted work.

Informed Consent

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

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Alarcón del Agua, I., Socas-Macias, M., Busetto, L. et al. Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation. OBES SURG 27, 1573–1580 (2017). https://doi.org/10.1007/s11695-016-2495-3

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  • DOI: https://doi.org/10.1007/s11695-016-2495-3

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