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Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay

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Abstract

Introduction

There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery.

Method

Prospective randomised study of patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm), where an IGB was inserted within the 6 months before surgery, and the control arm (C-arm).

Results

The study included 66 patients: 65.6% women, 69.6% with bypass. Age: 43 years (SD 10.2) B-arm and 42.6 years (SD 9.2) in the C-arm. We found 34.4% therapeutic failures in IGB. The mean body weight loss, %EWL and BMI reduction before surgery was 16.2 kg (SD 9.84) B-arm versus 4.7 (SD 8.70) in the C-arm, 23.6% versus 4.7% (p < 0.001) and 6.04 versus 1 (p < 0.001), respectively. The hospital stay was 7 days (p25–75: 5–8) B-arm and 7 days (p25–75: 5–9) in the C-arm (p = 0.937). Post-surgical morbidity with IGB was 25% versus 29.5% in the C-arm, p = 0.689. The number needed to treat (NNT) to prevent of post-surgical morbidity was 23 patients. The B-arm presented 54.5% moderate-severe post-surgical adverse events (12.5%) versus 82.6% in the C-arm (23.5%), p = 0.111. The cost of placing a balloon was more than 4000 Euros each.

Conclusions

The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations. The balloon achieves a higher weight loss result when compared to a diet programme, its added cost must also be given due consideration.

Trail Registry

This study has been registered on ClinicalTrials.gov with the Identifier: NCT01998243 (November 28, 2013).

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Acknowledgements

The authors express their gratitude to the four nurses Concepción Cuevas, Anabel Isabel García, Susana Álvarez and Beatriz Rodríguez who helped us and assisted in all the endoscopic procedures.

Funding

This study was supported by and funded by a National Grant coming from the Spanish Healthcare System P1070682.

Author information

All authors helped in performing the research and approved the manuscript. This study was conceived, designed, reviewed and the manuscript was edited by LRRT and CV. The endoscopic procedures were performed and the data base was filled up by LRRT, DCP and MPF. The adverse events were analysed and revised (following the criteria of the simplified classification “Accordion Severity Grading System”) as by external researchers: MAR and LACH. Materials/analysis tools were contributed by: MDMR and RBM. The surgical team performed all the surgical procedures: JRM, JV-E and NHM.

Correspondence to Luis R. Rabago Torre.

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Disclosure

Cristina Vicente Martin, Luis R. Rabago Torre, Luis A. Castillo Herrera, Marisa Arias Rivero, Miguel Perez Ferrer, David Collado Pacheco, Maria Dolores Martin Rios, Raquel Barba Martin, Javier Ramiro Martin, Jaime Vazquez‑Echarri, and Norberto Herrera Merino declare that they have no conflicts of interest or financial ties to disclose.

Ethical approval

The clinical research was approved by the Research and Ethics Committee of the Hospital Severo Ochoa, Leganes.

Informed consent

Written informed consents were obtained from the patients for using their data in scientific studies while protecting their anonymity before the procedure.

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Vicente Martin, C., Rabago Torre, L.R., Castillo Herrera, L.A. et al. Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay. Surg Endosc (2019). https://doi.org/10.1007/s00464-019-07061-w

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Keywords

  • Morbid obesity
  • Intragastric balloon
  • Surgical morbidity
  • Laparoscopic bariatric surgery
  • Gastric bypass
  • Vertical gastrectomy