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Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial)

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Abstract

Background

Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC).

Methods

This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727).

Results

The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25–265) vs. 55 min (range 22–185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups.

Conclusions

In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

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Acknowledgments

The study was supported by a research grant from the European Association for Endoscopic Surgery in 2011.

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Authors and Affiliations

  1. Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy

    Alberto Arezzo, Alberto Bullano, Maurizio Degiuli & Mario Morino

  2. Division of Nuclear Medicine, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy

    Roberto Passera

  3. Hadassah Hebrew University Medical Centre - General Surgery, Jerusalem, Israel

    Yoav Mintz & Asaf Kedar

  4. Minimally Invasive Surgery Research Center, Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy

    Luigi Boni & Elisa Cassinotti

  5. Department of Gastrointestinal Surgery, Università Vita e Salute San Raffaele, Milan, Italy

    Riccardo Rosati

  6. Department of Surgery, Istituto Clinico Humanitas, Rozzano, Italy

    Uberto Fumagalli Romario

  7. Department of Surgery, Latisana/Palmanova Hospital, AAS2 Bassa-Friulana-Isontina, Latisana, UD, Italy

    Mario Sorrentino & Marco Brizzolari

  8. Department of Experimental Medicine and Surgery, Università di Roma Tor Vergata, Rome, Italy

    Nicola Di Lorenzo & Achille Lucio Gaspari

  9. Department of Surgery, Ospedale San Luigi Gonzaga, Orbassano, TO, Italy

    Dario Andreone & Elena De Stefani

  10. Department of Surgery, University Hospital G. Martino, Messina, Italy

    Giuseppe Navarra & Salvatore Lazzara

  11. Department of Endoscopic Surgery, A.V. Vishnevsky Institute of Surgery, Moscow, Russia

    Kirill Shishin

  12. Moscow Clinical Scientific Centre, Central Scientific Research Institute of Gastroenterology, Moscow, Russia

    Igor Khatkov & Ivan Kazakov

  13. Department of Surgery, LKH Hochsteiermark/Standort Bruck an der Mur, Bruck an der Mur, Austria

    Rudolf Schrittwieser

  14. Klinik für Allgemein, Visceral und Unfallchirurgie, Klinikum Bremen-Ost, Bremen, Germany

    Thomas Carus & Alessio Corradi

  15. Department of Surgery, Ospedale di Brunico, Brunico, Italy

    Guenther Sitzman

  16. Department of Gastrointestinal Surgery, Hospital Clinic, University of Barcelona, Barcelona, Spain

    Antonio Lacy

  17. Department of Surgery, Medical University of Graz, Graz, Austria

    Selman Uranues

  18. Department of Surgery, Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel

    Amir Szold

Authors
  1. Alberto Arezzo
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  2. Roberto Passera
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  3. Alberto Bullano
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  4. Yoav Mintz
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  5. Asaf Kedar
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  6. Luigi Boni
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  7. Elisa Cassinotti
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  8. Riccardo Rosati
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  9. Uberto Fumagalli Romario
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  10. Mario Sorrentino
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  11. Marco Brizzolari
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  12. Nicola Di Lorenzo
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  13. Achille Lucio Gaspari
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  14. Dario Andreone
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  15. Elena De Stefani
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  16. Giuseppe Navarra
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  17. Salvatore Lazzara
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  18. Maurizio Degiuli
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  19. Kirill Shishin
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  20. Igor Khatkov
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  21. Ivan Kazakov
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  22. Rudolf Schrittwieser
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  23. Thomas Carus
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  24. Alessio Corradi
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  25. Guenther Sitzman
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  26. Antonio Lacy
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  27. Selman Uranues
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  28. Amir Szold
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  29. Mario Morino
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Corresponding author

Correspondence to Alberto Arezzo.

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Disclosures

Dr. Alberto Arezzo reports having received a grant from the European Association for Endoscopic Surgery to conduct this study. Dr. Luigi Boni reports having received travel grants from Karl Storz during this study. Drs. Roberto Passera, Alberto Bullano, Yoav Mintz, Asaf Kedar, Elisa Cassinotti, Riccardo Rosati, Uberto Fumagalli Romario, Mario Sorrentino, Marco Brizzolari, Nicola Di Lorenzo, Achille Lucio Gaspari, Dario Andreone, Elena De Stefani, Giuseppe Navarra, Salvatore Lazzara, Maurizio Degiuli, Kirill Shishin, Igor Khatkov, Ivan Kazakov, Rudolf Schrittwieser, Thomas Carus, Alessio Corradi, Guenther Sitzman, Antonio Lacy, Selman Uranues, Amir Szold, and Mario Morino have no conflicts of interest or financial ties to disclose.

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Arezzo, A., Passera, R., Bullano, A. et al. Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial). Surg Endosc 31, 2872–2880 (2017). https://doi.org/10.1007/s00464-016-5298-7

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  • DOI: https://doi.org/10.1007/s00464-016-5298-7

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