Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study.

Noguera, José; Tejada, Silvia; Tortajada, Carmen; Sánchez, Anna; Muñoz, José

BACKGROUND Natural orifice transumbilical endoscopic surgery (NOTES) is a technique still in experimental development that requires clinical trials to assess its safety and efficacy. We present a pilot prospective, randomized, three-arm clinical trial of 1-year duration that was conducted as a noninferiority trial comparing single-incision laparoscopic surgery (SILS) and flexible single-incision surgery (FSIS) with conventional laparoscopy for elective cholecystectomy (NCT01558414). METHODS Sixty patients between aged 18 and 65 years who were eligible for elective cholecystectomy were randomly assigned in a 1:1:1 ratio (n = 20 per group): group A (SILS), single-incision endoscopic surgery using a transumbilical SILSâ„¢ device; group B (FSIS), single-incision transumbilical surgery using a flexible endoscope; and group C (CL), conventional laparoscopy. The main outcome variable of the study was "parietal complications" (wound infection, bleeding, and ventral hernia). The analysis was by intention to treat and attritions were not replaced. RESULTS Cholecystectomy was performed in 100 % of the cases; perioperative complications occurred in only 1.6 % of the cases, and umbilical surgical wound infection in 3.33 %, with no differences between groups. After a minimum follow-up of 1 year, no differences were noted in the frequency of parietal complications and no ventral hernias occurred. Postoperative pain, hospital length of stay, and downtime from work were similar in all three groups. Surgical time was longer in cases in which a single-incision transumbilical approach was used (58.95 min for SILS and 54.15 for FSIS vs. 49.21 for laparoscopy). CONCLUSIONS Single-incision transumbilical approaches are not inferior for safety or effectiveness compared with conventional laparoscopy. The transumbilical approach using a flexible endoscope is just as effective and safe as the other two procedures and is a promising single-incision approach.