Melissa S Phillips, MD, Jeffrey M Marks, MD, Roberto Tacchino, MD, Kurt Roberts, MD, Raymond Onders, MD, George DeNoto, MD, Paraskevas Paraskeva, MD, Homero Rivas, MD, Arsalla Islam, MD, Nathaniel Soper, MD, Alexander Rosemurgy, MD, Sajani Shah, MD. University Hospitals Case Medical Center, Cleveland, OH, USA
Introduction: Since the first report of standard four port laparoscopic cholecystectomy (4PLC) in 1985, minimally invasive techniques have become an integral part of general surgery. 4PLC now is considered standard of care. Single incision laparoscopic cholecystectomy (SILC) was first described in 1997 with favorable outcomes in small series of non-randomized reports. This study presents a prospective randomized multi-center, single blinded trial of SILC versus 4PLC with the goal of assessing feasibility and safety.
Methods: Patients with biliary colic and documented gallstones or polyps, or those with biliary dyskinesia (documented EF < 30%) were randomized to SILC versus 4PLC in a 1.5-to-1 ratio. Patients were blinded for the first post-operative week. Data measures were operative time, estimated blood loss, length of hospital stay, adverse events, and conversion to 4PLC or laparotomy. Additionally, pain, satisfaction and cosmetic scoring was performed by the patient over the 12 month follow-up.
Results: 186 patients underwent randomization to SILC (n=111) or 4PLC (n=85). Patient characteristics were similar, except for body mass index which was significantly lower in the SILC group (28.9 vs. 31.0, p<0.0018). One patient randomized to SILC required conversion to 4PLC for intraoperative bleeding. There were no common bile duct injuries. Each arm had one port site hernia and one episode of retained common duct stones, treated with ERCP. SILC had a statistically significant longer operative time than 4PLC (57 vs. 45 min, p<0.0001), but no difference in operative blood loss. The SILC group had a statistically significant higher pain score (1 point difference) on days 3 and 5, however, there was no difference in the analgesic use amongst all days between the two groups and no difference in reported pain after day 5. The self-reported body image and confidence scores as well as the physician-reported Hollander scores were similar, except for at one month when body image scores favored SILC. The patient-evaluated scar rating photo questionnaires significantly favored SILC across all time points. In addition, the cosmetic scale was statistically significant favoring SILC at 1, 2, 4, and 12 weeks. Satisfaction scores, however, were in favor of 4PLC at 3 days and 4 weeks for the SF-8 and SF-12 respectively, but all other time points did not reach statistical difference.
Conclusions: In this randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar complication profile. Reported pain scores were higher for SILC patients in the early post-op period although analgesic use was comparable. Satisfaction scores were also higher initially in the 4PLC, possibly related to this. SILC showed increased self-reported cosmetic results up to 3 months when compared to 4PLC. In addition, patient preference and cosmesis scoring favored SILC. For patients preferring a more cosmetic outcome and accepting of possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC.
Program Number: S033