Surgical Endoscopy

, Volume 26, Issue 5, pp 1296–1303

Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy

Authors

    • Department of SurgeryUniversity Hospitals Case Medical Center, Case Western Reserve University
  • Jeffrey M. Marks
    • Department of SurgeryUniversity Hospitals Case Medical Center, Case Western Reserve University
  • Kurt Roberts
    • Yale School of Medicine
  • Roberto Tacchino
    • Catholic University of Sacred Heart
  • Raymond Onders
    • Department of SurgeryUniversity Hospitals Case Medical Center, Case Western Reserve University
  • George DeNoto
    • North Shore University Hospital
  • Homero Rivas
    • University of Texas Southwestern Medical Center
  • Arsalla Islam
    • University of Texas Southwestern Medical Center
  • Nathaniel Soper
    • Northwestern Memorial Hospital
  • Gary Gecelter
    • St. Francis Hospital
  • Eugene Rubach
    • St. Francis Hospital
  • Paraskevas Paraskeva
    • Imperial College of London
  • Sajani Shah
    • Tufts Medical Center
Article

DOI: 10.1007/s00464-011-2028-z

Cite this article as:
Phillips, M.S., Marks, J.M., Roberts, K. et al. Surg Endosc (2012) 26: 1296. doi:10.1007/s00464-011-2028-z

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 a prospective, randomized, multicenter, single-blind trial of SILC compared with four-port cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes.

Methods

Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months.

Results

Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p < 0.0001), but outcomes, including total adverse events, were similar (34% vs. 38%, p = 0.55). Cosmesis scores favored SILC (p < 0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p < 0.028) despite equal analgesia use. Wound complications were greater after SILC (10% vs. 3%, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3% vs. 3.4%, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores.

Conclusions

In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.

Keywords

Laparoscopic cholecystectomySingle incisionSILC

Copyright information

© Springer Science+Business Media, LLC 2011