Alberto Arezzo1, Roberto Passera2, Alberto Bullano3, Yoav Mintz4, Asaf Kedar4, Luigi Boni5, Elisa Cassinotti5, Riccardo Rosati6, Uberto Fumagalli Romario7, Mario Sorrentino8, Marco Brizzolari8, Nicola Di Lorenzo9, Achille Lucio Gaspari9, Dario Andreone10, Elena De Stefani10, Giuseppe Navarra11, Salvatore Lazzara11, Maurizio Degiuli3, Kirill Shishin12, Igor Khatkov13, Ivan Kazakov13, Rudolf Schrittwieser14, Thomas Carus15, Alessio Corradi15, Guenther Sitzman16, Antonio Lacy17, Selman Uranues18, Amir Szold19, Mario Morino3. 1. Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy. alberto.arezzo@unito.it. 2. Division of Nuclear Medicine, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy. 3. Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126, Turin, Italy. 4. Hadassah Hebrew University Medical Centre - General Surgery, Jerusalem, Israel. 5. Minimally Invasive Surgery Research Center, Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy. 6. Department of Gastrointestinal Surgery, Università Vita e Salute San Raffaele, Milan, Italy. 7. Department of Surgery, Istituto Clinico Humanitas, Rozzano, Italy. 8. Department of Surgery, Latisana/Palmanova Hospital, AAS2 Bassa-Friulana-Isontina, Latisana, UD, Italy. 9. Department of Experimental Medicine and Surgery, Università di Roma Tor Vergata, Rome, Italy. 10. Department of Surgery, Ospedale San Luigi Gonzaga, Orbassano, TO, Italy. 11. Department of Surgery, University Hospital G. Martino, Messina, Italy. 12. Department of Endoscopic Surgery, A.V. Vishnevsky Institute of Surgery, Moscow, Russia. 13. Moscow Clinical Scientific Centre, Central Scientific Research Institute of Gastroenterology, Moscow, Russia. 14. Department of Surgery, LKH Hochsteiermark/Standort Bruck an der Mur, Bruck an der Mur, Austria. 15. Klinik für Allgemein, Visceral und Unfallchirurgie, Klinikum Bremen-Ost, Bremen, Germany. 16. Department of Surgery, Ospedale di Brunico, Brunico, Italy. 17. Department of Gastrointestinal Surgery, Hospital Clinic, University of Barcelona, Barcelona, Spain. 18. Department of Surgery, Medical University of Graz, Graz, Austria. 19. Department of Surgery, Assia Medical Group, Assuta Medical Center, Tel Aviv, Israel.
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 painVAS 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.
RCT Entities:
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.
Entities:
Keywords:
Cholecystectomy; Randomized controlled trial; Single port surgery
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