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Surgical Endoscopy

, Volume 31, Issue 7, pp 2872–2880 | Cite as

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

  • Alberto ArezzoEmail author
  • Roberto Passera
  • Alberto Bullano
  • Yoav Mintz
  • Asaf Kedar
  • Luigi Boni
  • 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
  • Mario Morino
Article

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.

Keywords

Cholecystectomy Single port surgery Randomized controlled trial 

Notes

Acknowledgments

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

Compliance with ethical standards

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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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Alberto Arezzo
    • 1
    Email author
  • Roberto Passera
    • 2
  • Alberto Bullano
    • 1
  • Yoav Mintz
    • 3
  • Asaf Kedar
    • 3
  • Luigi Boni
    • 4
  • Elisa Cassinotti
    • 4
  • Riccardo Rosati
    • 5
  • Uberto Fumagalli Romario
    • 6
  • Mario Sorrentino
    • 7
  • Marco Brizzolari
    • 7
  • Nicola Di Lorenzo
    • 8
  • Achille Lucio Gaspari
    • 8
  • Dario Andreone
    • 9
  • Elena De Stefani
    • 9
  • Giuseppe Navarra
    • 10
  • Salvatore Lazzara
    • 10
  • Maurizio Degiuli
    • 1
  • Kirill Shishin
    • 11
  • Igor Khatkov
    • 12
  • Ivan Kazakov
    • 12
  • Rudolf Schrittwieser
    • 13
  • Thomas Carus
    • 14
  • Alessio Corradi
    • 14
  • Guenther Sitzman
    • 15
  • Antonio Lacy
    • 16
  • Selman Uranues
    • 17
  • Amir Szold
    • 18
  • Mario Morino
    • 1
  1. 1.Department of Surgical SciencesUniversity of TorinoTurinItaly
  2. 2.Division of Nuclear MedicineUniversity of TorinoTurinItaly
  3. 3.Hadassah Hebrew University Medical Centre - General SurgeryJerusalemIsrael
  4. 4.Minimally Invasive Surgery Research Center, Department of Surgical and Morphological SciencesUniversity of InsubriaVareseItaly
  5. 5.Department of Gastrointestinal SurgeryUniversità Vita e Salute San RaffaeleMilanItaly
  6. 6.Department of SurgeryIstituto Clinico HumanitasRozzanoItaly
  7. 7.Department of Surgery, Latisana/Palmanova HospitalAAS2 Bassa-Friulana-IsontinaLatisanaItaly
  8. 8.Department of Experimental Medicine and SurgeryUniversità di Roma Tor VergataRomeItaly
  9. 9.Department of SurgeryOspedale San Luigi GonzagaOrbassanoItaly
  10. 10.Department of SurgeryUniversity Hospital G. MartinoMessinaItaly
  11. 11.Department of Endoscopic SurgeryA.V. Vishnevsky Institute of SurgeryMoscowRussia
  12. 12.Moscow Clinical Scientific CentreCentral Scientific Research Institute of GastroenterologyMoscowRussia
  13. 13.Department of SurgeryLKH Hochsteiermark/Standort Bruck an der MurBruck an der MurAustria
  14. 14.Klinik für Allgemein, Visceral und UnfallchirurgieKlinikum Bremen-OstBremenGermany
  15. 15.Department of SurgeryOspedale di BrunicoBrunicoItaly
  16. 16.Department of Gastrointestinal SurgeryHospital Clinic, University of BarcelonaBarcelonaSpain
  17. 17.Department of SurgeryMedical University of GrazGrazAustria
  18. 18.Department of SurgeryAssia Medical Group, Assuta Medical CenterTel AvivIsrael

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