title: A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.
abstract: BACKGROUND
  The Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda. This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes.
  
  
  METHODS
  A double-blinded randomized controlled trial (NCT01489436) was conducted. Baseline data were obtained, standardized anesthesia was induced, and patients were randomized to single-port (SP) or 4-port (FP) laparoscopic cholecystectomy. Perioperative care was standardized. The outcomes were pain (Visual Analog Scale) on postoperative day 1 (primary) and quality of life (Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment), serum cytokines, and heart rate variability (secondary). Analysis was intention to treat. Using identical occlusive dressings, patients and the outcomes assessor remained blinded until postoperative day 2.
  
  
  RESULTS
  Fifty-five patients were randomized to each arm. There was no difference in demographics. Visual Analog Scale pain score on postoperative day 1 was significantly different from baseline in each group (SP: 1.6 ± 1.9 to 4.2 ± 2.4 vs FP: 1.8 ± 2.3 to 4.2 ± 2.2), but not different from each other (p = 0.83). Patients in the FP arm reported significantly less fatigue on postoperative day 7 than patients in the SP group (3.1 ± 2.1 vs 4.2 ± 2.2; p = 0.009). Fewer patients in the FP group required postoperative oral narcotics before discharge (40% vs 60%; p = 0.056). Cytokines levels and heart rate variability were similar between arms. In patients followed for >1 year, no difference in umbilical hernia rates was noted.
  
  
  CONCLUSIONS
  Early postoperative quality of life data captured differences in fatigue, indicating improved recovery after FP within a controlled trial. Physiologic measures were similar, suggesting that the differences between SP and FP are minimal.
authors.affiliation: Department of Surgery, Mayo Clinic, Rochester, MN. Electronic address: Bingenercasey.juliane@mayo.edu.
authors.forename: Juliane
authors.initials: J
authors.lastname: Bingener
authors.affiliation: Department of Surgery, Mayo Clinic, Rochester, MN.
authors.forename: Pam
authors.initials: P
authors.lastname: Skaran
authors.affiliation: Department of Surgery, Mayo Clinic, Rochester, MN.
authors.forename: Andrea
authors.initials: A
authors.lastname: McConico
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
authors.forename: Paul
authors.initials: P
authors.lastname: Novotny
authors.affiliation: Department of Surgery and Immunology, Mayo Clinic, Rochester, MN.
authors.forename: Peter
authors.initials: P
authors.lastname: Wettstein
authors.affiliation: Department of Neurology, Mayo Clinic, Rochester, MN.
authors.forename: David M
authors.initials: DM
authors.lastname: Sletten
authors.affiliation: Department of Surgery, Mayo Clinic, Rochester, MN.
authors.forename: Myung
authors.initials: M
authors.lastname: Park
authors.affiliation: Department of Neurology, Mayo Clinic, Rochester, MN.
authors.forename: Philip
authors.initials: P
authors.lastname: Low
authors.affiliation: Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
authors.forename: Jeff
authors.initials: J
authors.lastname: Sloan
mesh_terms: D000328:Adult; D000368:Aged; D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D057186:Comparative Effectiveness Research; D004311:Double-Blind Method; D005221:Fatigue / Q000175:diagnosis / Q000209:etiology; D005260:Female; D005705:Gallbladder Diseases / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology; D063868:Patient Outcome Assessment; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology; D011788:Quality of Life; D057566:Self Report