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No relevant difference in quality of life and functional outcome at 12 months’ follow-up—a randomised controlled trial comparing robot-assisted versus conventional laparoscopic Nissen fundoplication

  • Controlled Prospective Clinical Trials
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Abstract

Purpose

The present randomised pilot trial was designed to compare robot-assisted (RALF) and conventional laparoscopic fundoplication (CLF) focussing on post-operative quality of life (QOL) and functional outcome. Any long-lasting advantages for patients in this regard could be a justification for the use of RALF for the treatment of gastroesophageal reflux disease (GERD).

Methods

Forty patients with GERD were randomised to either RALF or to CLF. During a follow-up period of 12 months, patients’ QOL and functional outcome were investigated using disease-specific questionnaires.

Results

There were no significant differences in the mean QOL (1.3 versus 1.1; P = 0.374) and functional outcome (1.27 versus 1.3; P = 0.913) between both groups. Minor side effects such as bloating and persistent diarrhoea were present in four patients of each group.

Conclusion

The present study did not show any benefit for RALF over CLF regarding QOL and functional outcome at 12 months’ follow-up.

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Acknowledgement

The present study was conducted within the setting of the “Research training group 1126: Intelligent Surgery—Development of computer-based methods for the future workplace in surgery” funded by the German Research Foundation. The authors would like to thank Vasile V. Bintintan, MD for his assistance in the accomplishment of this trial.

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Authors and Affiliations

  1. Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany

    B. P. Müller-Stich, M. A. Reiter, A. Mehrabi, M. N. Wente, L. Fischer, J. Köninger & C. N. Gutt

Authors
  1. B. P. Müller-Stich
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  2. M. A. Reiter
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  3. A. Mehrabi
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  4. M. N. Wente
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  5. L. Fischer
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  6. J. Köninger
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  7. C. N. Gutt
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Corresponding author

Correspondence to C. N. Gutt.

Additional information

B. P. Müller-Stich and M. A. Reiter contributed equally to this work.

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Müller-Stich, B.P., Reiter, M.A., Mehrabi, A. et al. No relevant difference in quality of life and functional outcome at 12 months’ follow-up—a randomised controlled trial comparing robot-assisted versus conventional laparoscopic Nissen fundoplication. Langenbecks Arch Surg 394, 441–446 (2009). https://doi.org/10.1007/s00423-008-0446-8

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  • DOI: https://doi.org/10.1007/s00423-008-0446-8

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