Validation of the Individual Metabolic Surgery Score for Bariatric Procedure Selection in the Merged Data of Two Randomized Clinical Trials (SLEEVEPASS and SM-BOSS)


Footnotes

SUMMARY

In the 5-year merged individual patient-level data of SLEEVEPASS and SM-BOSS randomized clinical trials comparing sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) including 121 patients with obesity and type II diabetes (T2D), remission rates of diabetes were not statistically different after SG and RYGB among all patients and among patients with mild, moderate and severe diabetes stratified by the Individual Metabolic Surgery (IMS) score. However, the IMS score may be useful in predicting T2D remission after bariatric surgery.

ACKNOWLEDGEMENTS

Author Contributions

Drs Saarinen, Grönroos and Salminen had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analyses. Dr. Salminen had the final responsibility for the decision to submit the manuscript for publication.

Concept and design: Saarinen, Grönroos, Hurme, Strandberg, Peterli, Bueter, Wölnerhanssen, and Salminen

Acquisition, analysis, or interpretation of data: Saarinen, Grönroos, Hurme, Helmiö, Peterli, Bueter, Strandberg, Wölnerhanssen, and Salminen

Drafting of the manuscript: Saarinen, Grönroos, Hurme, Strandberg, and Salminen

Critical revision of the manuscript: Helmiö, Peterli, Wölnerhanssen, Bueter, Saarinen, Grönroos, Hurme, Strandberg, and Salminen

Statistical analyses: Saarinen, Grönroos, Hurme, and Salminen

Administrative, technical, or material support: Saarinen, Grönroos, Hurme, Helmiö, Peterli, Bueter, Strandberg, Wölnerhanssen and Salminen

Supervision: Salminen

Funding/Support

The SLEEVEPASS trial was supported by the Mary and Georg C. Ehrnrooth Foundation (Dr Salminen), by a government research grant from the EVO Foundation awarded to Turku University Hospital (Dr Salminen, Dr Helmiö), by the Gastroenterological Research Foundation (Dr Grönroos), and by The Finnish Medical Foundation (Dr Grönroos).

The SM-BOSS trial was funded by the Swiss National Science Foundation, and Ethicon Endo Surgery USA.

Role of the Funder/Sponsor

The study funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Conflict of Interest Disclosures

All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. No other authors reported disclosures.

Data sharing statement

The data will be made available by request from the corresponding author based on the request.

Additional contributions

The authors give their thanks to all trial patients. We thank all the collaborators in original trials: A. Juuti, A.C. Meyer-Gerspach, M. Slawik, P. Peromaa-Haavisto, T. Peters, D. Vetter, D. Kröll, Y. Borbely, B. Schultes, C. Beglinger, J. Drewe, M. Schiesser, P. Nett, J. Ovaska, M. Leivonen and M. Soinio. They also express thanks to M. Victorzon (Department of Surgery, University of Turku, and Vaasa Central Hospital, Vaasa, Finland) who was involved in this trial, but passed away before this work was submitted.



Source link

Home  Articles  Disclaimer  Contact Us