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Standardization of Surgical Technique in Antireflux Surgery: The LOTUS Trial Experience

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Abstract

Background

To date, it has been difficult to compare medical therapy for gastroesophageal reflux disease with that of surgical management from a scientific viewpoint, mainly because of the lack of standardization of the operative technique. This study was designed to identify a methodology for standardization of surgical technique and to measure the effectiveness of this standardization.

Methods

Surgeons contributing to a major international multicenter trial comparing optimum medical therapy with surgical therapy for treatment of gastroesophageal reflux attempted to optimize their surgical techniques so that a realistic comparison could be made that may aid clinical decision-making. The surgeons met, shared their techniques using video, and produced a standardized set of criteria for the surgical centers and a common operative technique. Data collection methods ensured accuracy of the records of the procedure applied and the data were analyzed for consistency with set surgical standards.

Results

There was a high degree of conformity (>95%) between the recommended method of performing a Nissen fundoplication as defined in the trial protocol, and variations were restricted to isolated individuals. The operations were completed without mortality, few conversions, and with very low postoperative morbidity.

Conclusions

This study has shown that, contrary to commonly held belief, surgeons are able to standardize their work for the purposes of measuring the outcome of an operative procedure within the context of a randomized, controlled trial.

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Acknowledgments

The LOTUS study was funded by AstraZeneca. The authors thank all AstraZeneca personnel involved in the excellent planning and coordination of the study and acknowledge the high level of expertise and commitment provided by all of the principal investigators and participating centers, and also acknowledge Dr. Madeline Frame of AstraZeneca for medical writing assistance with the manuscript preparation.

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Authors and Affiliations

  1. Department of Surgery, Northumbria Healthcare, North Tyneside Hospital, Rake Lane, North Shields, NE29 8NH, United Kingdom

    Stephen E. A. Attwood

  2. Department of Surgery, Karolinska University Hospital, Stockholm, Sweden

    Lars Lundell

  3. Department of Internal Medicine II, Dr. Horst Schmidt Kliniken, D-65199, Wiesbaden, Germany

    Christian Ell

  4. Department of Hepatogastroenterology, Hotel Dieu- CHU de Nantes, F-44035, Nantes Cedex, France

    Jean-Paul Galmiche

  5. Institute of Medicine, Haukeland University Hospital, University of Bergen, N-5021, Bergen, Norway

    Jan Hatlebakk

  6. Department of Surgical and Morphological Sciences, Division of Anatomical Pathology, University of Genoa, Genoa, Italy

    Roberto Fiocca

  7. AstraZeneca R&D, 43183, Mölndal, Sweden

    Tore Lind, Stefan Eklund & Ola Junghard

Authors
  1. Stephen E. A. Attwood
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  2. Lars Lundell
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  3. Christian Ell
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  4. Jean-Paul Galmiche
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  5. Jan Hatlebakk
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  6. Roberto Fiocca
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  7. Tore Lind
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  8. Stefan Eklund
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  9. Ola Junghard
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Consortia

The LOTUS Trial Group

Corresponding author

Correspondence to Stephen E. A. Attwood.

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Attwood, S.E.A., Lundell, L., Ell, C. et al. Standardization of Surgical Technique in Antireflux Surgery: The LOTUS Trial Experience. World J Surg 32, 995–998 (2008). https://doi.org/10.1007/s00268-007-9409-4

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  • DOI: https://doi.org/10.1007/s00268-007-9409-4

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