title: Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314.
abstract: BACKGROUND
  Single-incision minimally invasive surgery has previously been associated with incisions 2.0-3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar we previously described in six patients with short-term follow-up data. The objective of this phase II study was to evaluate the safety and feasibility of the platform in a larger collective and to evaluate 1-year follow-up data of the phase I trial.
  
  
  METHODS
  The technology features a multiple-use introducer, accommodating the articulating instruments, and is inserted through a 15-mm laparoscopic trocar. Cholecystectomy is performed through an umbilical incision. A prospective feasibility study was performed at a single center. Inclusion criteria were age of 18-75 years and biliary colic, exclusion criteria were acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m(2), or choledocholithiasis. Endpoints included complications, length of stay, pain medication, cosmetic results, and the presence of hernia.
  
  
  RESULTS
  Twenty-seven patients (23 females; phase I: 6 patients, phase II: 21 patients) with an average age of 41.7 years and BMI 26.6 kg/m(2) were recruited for the study. Umbilical incision length did not exceed 15 mm. There were no intraoperative complications. Average OR time decreased from 91 min for the first six cases to 56 min for the last six cases. Average length of stay was 7.8 h. Pain control was achieved with diclofenac for no more than 7 days. All patients had no adverse events at 5-month follow-up, and all phase I patients had no adverse events nor evidence of umbilical hernia at 1 year.
  
  
  CONCLUSIONS
  This study demonstrates that single-incision cholecystectomy with the platform is feasible, safe, and reproducible in a larger patient population. Long-term follow-up showed no hernias or other adverse events. Further studies will be needed to evaluate longer-term hernia rates.
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.|Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Martin
authors.initials: M
authors.lastname: Berducci
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA. hans-fuchs@freenet.de.|Department of Surgery, University of Cologne, Cologne, Germany. hans-fuchs@freenet.de.
authors.forename: Hans F
authors.initials: HF
authors.lastname: Fuchs
authors.affiliation: Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Pablo
authors.initials: P
authors.lastname: Omelanczuk
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.
authors.forename: Ryan C
authors.initials: RC
authors.lastname: Broderick
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.
authors.forename: Cristina R
authors.initials: CR
authors.lastname: Harnsberger
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.
authors.forename: Joshua
authors.initials: J
authors.lastname: Langert
authors.affiliation: Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Jorge
authors.initials: J
authors.lastname: Nefa
authors.affiliation: Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Pablo
authors.initials: P
authors.lastname: Jaureguiberry
authors.affiliation: Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Pablo
authors.initials: P
authors.lastname: Gomez
authors.affiliation: Hospital Italiano de Mendoza, Mendoza, Argentina.
authors.forename: Laura
authors.initials: L
authors.lastname: Miranda
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.
authors.forename: Garth R
authors.initials: GR
authors.lastname: Jacobsen
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.|VA Healthcare, San Diego, San Diego, CA, USA.
authors.forename: Bryan J
authors.initials: BJ
authors.lastname: Sandler
authors.affiliation: Division of Minimally Invasive Surgery, Department of Surgery, Center for the Future of Surgery, University of California, San Diego, 9500 Gilman Drive, MC 0740, La Jolla, CA, 92093-0740, USA.
authors.forename: Santiago
authors.initials: S
authors.lastname: Horgan
mesh_terms: D000328:Adult; D000368:Aged; D017081:Cholecystectomy, Laparoscopic / Q000295:instrumentation* / Q000379:methods*; D002764:Cholecystitis / Q000601:surgery; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011446:Prospective Studies; D014472:Umbilicus; D055815:Young Adult
keywords: Cholecystectomy; Laparoscopic cholecystectomy; Minimal access surgery; Minimally invasive surgery; New technology; Single-site surgery