Single-Incision Laparoscopic Cholecystectomy Is Associated with Improved Cosmesis Scoring at the Cost of Significantly Higher Hernia Rates: 1-Year Results of a Prospective Randomized, Multicenter, Single-Blinded Trial of Traditional Multiport Laparoscopic Cholecystectomy vs Single-Incision Laparoscopic Cholecystectomy - 17/05/13

Doi : 10.1016/j.jamcollsurg.2013.02.024

Jeffrey M. Marks, MD, FACS ^a,^⁎ , Melissa S. Phillips, MD ^b, Roberto Tacchino, MD ^c, Kurt Roberts, MD ^d, Raymond Onders, MD, FACS ^a, George DeNoto, MD, FACS ^e, Gary Gecelter, MD, FACS ^f, Eugene Rubach, MD ^f, Homero Rivas, MD, FACS ^g, Arsalla Islam, MD ^g, Nathaniel Soper, MD, FACS ^h, Paraskevas Paraskeva, MD, PhD, FRCS ⁱ, Alexander Rosemurgy, MD, FACS ^j, Sharona Ross, MD ^j, Sajani Shah, MD ^k
^a Department of Surgery, University Hospitals of Cleveland, Case Medical Center, Cleveland, OH
^b Department of Surgery, University of Tennessee Graduate School of Medicine, Knoxville, TN
^c Department of Surgery, Catholic University of Sacred Heart, Rome, Italy
^d Department of Surgery, Yale New Haven Medical Center, New Haven, CT
^e Department of Surgery, North Shore University Hospital, Manhasset, NY
^f Department of Surgery, St Francis Hospital, Roslyn, NY
^g Department of Surgery, UT Southwestern Medical Center, Dallas, TX
^h Department of Surgery, Northwestern Memorial Hospital, Chicago, IL
ⁱ Department of Surgery, Imperial College of London, London, UK
^j Department of Surgery, Tampa General Hospital, Tampa, FL
^k Department of Surgery, Tufts Medical Center, Boston, MA

Correspondence address: Jeffrey M Marks, MD, FACS, University Hospitals, Case Medical Center, 11100 Euclid Ave, Mail Stop 5047, Cleveland, OH 44106.

Abstract

Background

Minimally invasive techniques have become an integral part of general surgery with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents the final 1-year results of a prospective, randomized, multicenter, single-blinded trial of SILC vs multiport cholecystectomy (4PLC).

Study Design

Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC vs 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Patients were followed for 12 months.

Results

Two hundred patients underwent randomization to SILC (n = 119) or 4PLC (n = 81). Enrollment ranged from 1 to 50 patients with 4 sites enrolling >25 patients. Total adverse events were not significantly different between groups (36% 4PLC vs 45% SILC; p = 0.24), as were severe adverse events (4% 4PLC vs 10% SILC; p = 0.11). Incision-related adverse events were higher after SILC (11.7% vs 4.9%; p = 0.13), but all of these were listed as mild or moderate. Total hernia rates were 1.2% (1 of 81) in 4PLC patients vs 8.4% (10 of 119) in SILC patients (p = 0.03). At 1-year follow-up, cosmesis scores continued to favor SILC (p < 0.0001).

Conclusions

Results of this trial show SILC to be a safe and feasible procedure when compared with 4PLC, with similar total adverse events but with an identified significant increase in hernia formation. Cosmesis scoring and patient preference at 12 months continue to favor SILC, and more than half of the patients were willing to pay more for a single-site surgery over a standard laparoscopic procedure. Additional longer-term population-based studies are needed to clarify if this increased rate of hernia formation as compared with 4PLC will continue to hold true.

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Plan

Methods

Procedure

Single-incision laparoscopic cholecystectomy surgical technique

Multiport laparoscopic cholecystectomy surgical technique

Postoperative care

Statistics

Sample size considerations

Disclosure Information: This study was sponsored by Covidien (Norwalk, CT). Dr Rivas has received an honorarium as a speaker for Covidien. All other authors have nothing to disclose.