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Prospective evaluation of transoral outlet reduction (TORe) after Roux-en-Y gastric bypass (RYGB) failure

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Abstract

Background and aims

Weight regain after RYGB is multifactorial including dilatation of the gastro-jejunal anastomosis. Transoral outlet reduction (TORe) procedure is a minimally invasive alternative to surgical anastomotic revision.

Methods

We conducted a prospective, multicenter, simple blind, randomized study in patients with weight regain following RYGB, comparing the efficacy of conventional nutritional and behavioral management associated with a TORe procedure (TORe group) with conventional management alone and a Sham procedure (Sham group). The main objective of this study was to evaluate the percentage of excess weight loss (%EWL) at 12 months after endoscopy.

Results

From January 2015 to January 2019, 73 subjects were randomized in four French Bariatric centers. The final analysis involved 50 subjects, 25 in each group, 44 women, 6 men, with an average BMI of 40.6 kg/m2.

At 12 months, the average %EWL was significantly higher in the TORe group than in the Sham group (13.5 ± 14.1 vs. − 0.77 ± 17.1; p = 0.002). Cohen’s d was 0.91, indicating a large effect size of the procedure on the %EWL.

There was no significant difference between groups concerning the improvement of obesity-related comorbidities (diabetes and dyslipidemia) and quality of life at 12 months. We report frequent adverse events in the TORe group (20% had adverse events related to the procedure). Three adverse events were serious, including two perforations of the gastro-jejunal anastomosis after TORe group that led to the premature termination of the study.

Conclusions

After RYGBP failure linked to the dilatation of the gastro-jejunal anastomosis, TORe procedure with nutritional management results in significantly higher %EWL at 12 months compared to patients with nutritional management alone. As surgery, this minimally invasive endoscopic procedure can be associated with severe adverse events.

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Acknowledgements

We thank Audrey Jaussent for careful data management.

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Authors and Affiliations

  1. Hepato-Gastro-Enterology, Montpellier University Hospital, Montpellier, France

    Jean-Christophe Valats & Franz Rudler

  2. Digestive Surgery, IRCAD Strasbourg Hospital, Strasbourg, France

    Silvana Perreta & Lee Swanstrom

  3. Digestive Surgery, Polyclinic Lyon-Nord Rillieux-La-Pape, Rillieux-La-Pape, France

    Jérôme Dargent

  4. Hepato-Gastro-Enterology, Lille University Hospital, Lille, France

    Julien Branche

  5. Clinical Research and Epidemiology Unit, INSERM, Centre d’Investigation Clinique 1411, CHU Montpellier, Univ Montpellier, 34 295, Montpellier Cedex 5, France

    Marie-Christine Picot

  6. Digestive Surgery, Montpellier University Hospital, Montpellier, France

    Andrew Currie, Marius Nedelcu & David Nocca

  7. Department of Biostatistics and Medical Information, Montpellier University Hospital, Montpellier, France

    Vera Georgescu

  8. Clinical Research and Epidemiology Unit, Montpellier University Hospital, Montpellier, France

    Valérie Macioce

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  1. Jean-Christophe Valats
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  2. Silvana Perreta
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  3. Lee Swanstrom
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  11. Franz Rudler
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  12. David Nocca
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Corresponding author

Correspondence to Jean-Christophe Valats.

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Disclosures

Jean-Christophe Valats, Silvana Perretta, Lee Swanstrom, Julien Branche, Marie-Christine PICOT, Andrew Currie, Vera Georgescu, Valérie Macioce, Marius Nedelcu, David Nocca have no conflicts of interest or financial ties to disclose.

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Valats, JC., Perreta, S., Swanstrom, L. et al. Prospective evaluation of transoral outlet reduction (TORe) after Roux-en-Y gastric bypass (RYGB) failure. Surg Endosc 38, 1454–1464 (2024). https://doi.org/10.1007/s00464-023-10650-5

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  • DOI: https://doi.org/10.1007/s00464-023-10650-5

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