title: Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy.
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.
authors.affiliation: Department of Surgery, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Ave., Lakeside 7, Mailstop 5047, Cleveland, OH 44106, USA. Phillips.Melissa@gmail.com
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Phillips
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Marks
authors.forename: Kurt
authors.initials: K
authors.lastname: Roberts
authors.forename: Roberto
authors.initials: R
authors.lastname: Tacchino
authors.forename: Raymond
authors.initials: R
authors.lastname: Onders
authors.forename: George
authors.initials: G
authors.lastname: DeNoto
authors.forename: Homero
authors.initials: H
authors.lastname: Rivas
authors.forename: Arsalla
authors.initials: A
authors.lastname: Islam
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Soper
authors.forename: Gary
authors.initials: G
authors.lastname: Gecelter
authors.forename: Eugene
authors.initials: E
authors.lastname: Rubach
authors.forename: Paraskevas
authors.initials: P
authors.lastname: Paraskeva
authors.forename: Sajani
authors.initials: S
authors.lastname: Shah
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000601:surgery*; D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D014472:Umbilicus; D055815:Young Adult
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