Stefano Partelli1,2, Giuliano Barugola1, Alberto Sartori1, Stefano Crippa1,2, Massimo Falconi1,2, Giacomo Ruffo3. 1. Department of Surgery, Ospedale "Sacro Cuore-Don Calabria", Via Don Sempreboni, 5, 37024, Negrar (Vr), Italy. 2. Polytechnic University of Marche Region, Ancona, Italy. 3. Department of Surgery, Ospedale "Sacro Cuore-Don Calabria", Via Don Sempreboni, 5, 37024, Negrar (Vr), Italy. giacomo.ruffo@sacrocuore.it.
Abstract
PURPOSES: Traditional laparoscopic cholecystectomy (TLC) is performed widely; however, single-incision cholecystectomy (SILC) has been proposed as a better and less traumatic procedure. METHODS: In this prospective, double-blinded, randomized study, patients were randomized to undergo either elective SILC or TLC. The primary endpoint was the level of pain after surgery and the secondary endpoints were complications, cosmetic outcomes, and patient satisfaction. RESULTS: A total of 59 patients were enrolled (SILC, n = 30; TLC, n = 29). The median operative time was longer for the SILC group (55 vs. 40 min; P < 0.0001). Patients in the SILC group had a lower median VAS pain score 4 h after surgery (20 mm for the TLC group vs. 15 mm for the SILC group). Complications were distributed equally. Twenty-eight of the 30 patients in the SILC group vs. 23 of the 29 patients in the TLC group were very satisfied with their operation (P = 0.032). The cosmetic results of SILC were better than those of TLC, with visible scars in 21 patients from the TLC group vs. 3 patients from the SILC group (P = 0.0001). CONCLUSIONS: We found SILC to be a safe, feasible, and adaptable surgical technique. The pain scores at 4 h were significantly better for SILC than for TLC.
RCT Entities:
PURPOSES: Traditional laparoscopic cholecystectomy (TLC) is performed widely; however, single-incision cholecystectomy (SILC) has been proposed as a better and less traumatic procedure. METHODS: In this prospective, double-blinded, randomized study, patients were randomized to undergo either elective SILC or TLC. The primary endpoint was the level of pain after surgery and the secondary endpoints were complications, cosmetic outcomes, and patient satisfaction. RESULTS: A total of 59 patients were enrolled (SILC, n = 30; TLC, n = 29). The median operative time was longer for the SILC group (55 vs. 40 min; P < 0.0001). Patients in the SILC group had a lower median VAS pain score 4 h after surgery (20 mm for the TLC group vs. 15 mm for the SILC group). Complications were distributed equally. Twenty-eight of the 30 patients in the SILC group vs. 23 of the 29 patients in the TLC group were very satisfied with their operation (P = 0.032). The cosmetic results of SILC were better than those of TLC, with visible scars in 21 patients from the TLC group vs. 3 patients from the SILC group (P = 0.0001). CONCLUSIONS: We found SILC to be a safe, feasible, and adaptable surgical technique. The pain scores at 4 h were significantly better for SILC than for TLC.
Entities:
Keywords:
Cholecystectomy; Laparoscopic; Outcomes; Pain; Randomized; Single incision
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