title: Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).
abstract: 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).
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
authors: Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy. alberto.arezzo@unito.it.
authors: Alberto
authors: 0000-0002-2110-4082
authors: A
authors: Arezzo
authors: Division of Nuclear Medicine, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy.
authors: Roberto
authors: R
authors: Passera
authors: Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy.
authors: Alberto
authors: A
authors: Bullano
authors: Hadassah Hebrew University Medical Centre - General Surgery, Jerusalem, Israel.
authors: Yoav
authors: Y
authors: Mintz
authors: Hadassah Hebrew University Medical Centre - General Surgery, Jerusalem, Israel.
authors: Asaf
authors: A
authors: Kedar
authors: Minimally Invasive Surgery Research Center, Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
authors: Luigi
authors: L
authors: Boni
authors: Minimally Invasive Surgery Research Center, Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
authors: Elisa
authors: E
authors: Cassinotti
authors: Department of Gastrointestinal Surgery, Università Vita e Salute San Raffaele, Milan, Italy.
authors: Riccardo
authors: R
authors: Rosati
authors: Department of Surgery, Istituto Clinico Humanitas, Rozzano, Italy.
authors: Uberto
authors: U
authors: Fumagalli Romario
authors: Department of Surgery, Latisana/Palmanova Hospital, AAS2 Bassa-Friulana-Isontina, Latisana, UD, Italy.
authors: Mario
authors: M
authors: Sorrentino
authors: Department of Surgery, Latisana/Palmanova Hospital, AAS2 Bassa-Friulana-Isontina, Latisana, UD, Italy.
authors: Marco
authors: M
authors: Brizzolari
authors: Department of Experimental Medicine and Surgery, Università di Roma Tor Vergata, Rome, Italy.
authors: Nicola
authors: N
authors: Di Lorenzo
authors: Department of Experimental Medicine and Surgery, Università di Roma Tor Vergata, Rome, Italy.
authors: Achille Lucio
authors: AL
authors: Gaspari
authors: Department of Surgery, Ospedale San Luigi Gonzaga, Orbassano, TO, Italy.
authors: Dario
authors: D
authors: Andreone
authors: Department of Surgery, Ospedale San Luigi Gonzaga, Orbassano, TO, Italy.
authors: Elena
authors: E
authors: De Stefani
authors: Department of Surgery, University Hospital G. Martino, Messina, Italy.
authors: Giuseppe
authors: G
authors: Navarra
authors: Department of Surgery, University Hospital G. Martino, Messina, Italy.
authors: Salvatore
authors: S
authors: Lazzara
authors: Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy.
authors: Maurizio
authors: M
authors: Degiuli
authors: Department of Endoscopic Surgery, A.V. Vishnevsky Institute of Surgery, Moscow, Russia.
authors: Kirill
authors: K
authors: Shishin
authors: Moscow Clinical Scientific Centre, Central Scientific Research Institute of Gastroenterology, Moscow, Russia.
authors: Igor
authors: I
authors: Khatkov
authors: Moscow Clinical Scientific Centre, Central Scientific Research Institute of Gastroenterology, Moscow, Russia.
authors: Ivan
authors: I
authors: Kazakov
authors: Department of Surgery, LKH Hochsteiermark/Standort Bruck an der Mur, Bruck an der Mur, Austria.
authors: Rudolf
authors: R
authors: Schrittwieser
authors: Klinik für Allgemein, Visceral und Unfallchirurgie, Klinikum Bremen-Ost, Bremen, Germany.
authors: Thomas
authors: T
authors: Carus
authors: Klinik für Allgemein, Visceral und Unfallchirurgie, Klinikum Bremen-Ost, Bremen, Germany.
authors: Alessio
authors: A
authors: Corradi
authors: Department of Surgery, Ospedale di Brunico, Brunico, Italy.
authors: Guenther
authors: G
authors: Sitzman
authors: Department of Gastrointestinal Surgery, Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors: Antonio
authors: A
authors: Lacy
authors: Department of Surgery, Medical University of Graz, Graz, Austria.
authors: Selman
authors: S
authors: Uranues
authors: Department of Surgery, Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.
authors: Amir
authors: A
authors: Szold
authors: Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy.
authors: Mario
authors: M
authors: Morino
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017081:Cholecystectomy, Laparoscopic / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005705:Gallbladder Diseases / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
keywords: Cholecystectomy; Randomized controlled trial; Single port surgery