TY - JOUR
T1 - Multi-port versus single-port cholecystectomy
T2 - results of a multi-centre, randomised controlled trial (MUSIC trial)
AU - Arezzo, Alberto
AU - Passera, Roberto
AU - Bullano, Alberto
AU - Mintz, Yoav
AU - Kedar, Asaf
AU - Boni, Luigi
AU - Cassinotti, Elisa
AU - Rosati, Riccardo
AU - Fumagalli Romario, Uberto
AU - Sorrentino, Mario
AU - Brizzolari, Marco
AU - Di Lorenzo, Nicola
AU - Gaspari, Achille Lucio
AU - Andreone, Dario
AU - De Stefani, Elena
AU - Navarra, Giuseppe
AU - Lazzara, Salvatore
AU - Degiuli, Maurizio
AU - Shishin, Kirill
AU - Khatkov, Igor
AU - Kazakov, Ivan
AU - Schrittwieser, Rudolf
AU - Carus, Thomas
AU - Corradi, Alessio
AU - Sitzman, Guenther
AU - Lacy, Antonio
AU - Uranues, Selman
AU - Szold, Amir
AU - Morino, Mario
N1 - Publisher Copyright:
© 2016, Springer Science+Business Media New York.
PY - 2017/7/1
Y1 - 2017/7/1
N2 - 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.
AB - 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.
KW - Cholecystectomy
KW - Randomized controlled trial
KW - Single port surgery
UR - https://www.scopus.com/pages/publications/84992221795
U2 - 10.1007/s00464-016-5298-7
DO - 10.1007/s00464-016-5298-7
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C2 - 27778171
AN - SCOPUS:84992221795
SN - 0930-2794
VL - 31
SP - 2872
EP - 2880
JO - Surgical Endoscopy
JF - Surgical Endoscopy
IS - 7
ER -