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Clinical Trial
. 2017 Jul;31(7):2872-2880.
doi: 10.1007/s00464-016-5298-7. Epub 2016 Oct 24.

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

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

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

Alberto Arezzo et al. Surg Endosc. 2017 Jul.

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; Randomized controlled trial; Single port surgery.

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