A randomized controlled trial comparing single-incision laparoscopic cholecystectomy using a novel instrument to that using a common instrument.

Background: To evaluate the safety and feasibility of single incision laparoscopic cholecystectomy (SILC) using a novel instrument.

Methods: From September 2011 to June 2012, eligible patients (150 cases) were divided randomly into three groups: group A, SILC using a novel instrument; group B, SILC using a conventional instrument; and group C, conventional laparoscopic cholecystectomy (LC). Operative and postoperative outcomes were analyzed.

Results: The operative times for Group A [mean 40 min; rang 30-50 min] and Group B [mean 37.5 min; rang 25-50 min] demonstrated no significant differences (P = 0.610), but both times were longer than that in Group C [mean 25 min; rang 20-35 min] (Z = 25.165, P = 0.000; Z = 16.184, P = 0.000). There was no significant difference between the level of blood loss in Group A [mean 10.0 ml; range 5.0-20.0 ml] and Group B [mean 10.0 ml; range 5.0-20.0 ml] (P = 0.989), but the level in both groups was higher than that in Group C [mean 7.5 ml; range 5.0-10.0 ml] (Z = 12.571, P = 0.002; Z = 13.619, P = 0.001). There were no significant differences in patient satisfaction and pain scores (P = 0.519; P = 0.691) among the three groups. Complications occurred in 4 cases, including 1 case of bile injury and 3 cases of bile leakage. There were no complications in SILC with a novel instrument.

Conclusions: SILC require a longer operative time and more blood loss without benefit of patient satisfaction and pain scores. However, SILC with a novel instrument has fewer complications and a tendency to safer than SILC with a conservative instrument, and it could be a possible alternative in cholecystectomy.