title: Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy.
abstract: BACKGROUND
  There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen.
  
  
  METHODS
  This patient- and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis. Outcomes were registered on the day of operation (day 0), on postoperative days 1, 2, 3 and 30, and 12 months after surgery. Blinding of the patients was maintained until day 3. The primary endpoint was pain on movement measured on a visual analogue scale, reported repeatedly by the patient until day 3.
  
  
  RESULTS
  The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group. There was no significant difference between the groups with regard to any of the pain-related outcomes, on-demand administration of opioids or general discomfort. Median duration of surgery was 32·5 min longer in the SLC group (P < 0·001). SLC was associated with a reduced incidence of vomiting on day 0 (7 versus 22 per cent; P = 0·019). The incidences of wound-related problems were comparable. One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography. The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups. Cosmetic rating was significantly improved after SLC at 1 and 12 months (P < 0·001).
  
  
  CONCLUSIONS
  SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care. SLC may reduce postoperative vomiting.
  
  
  BACKGROUND
  NCT01268748 (http://www.clinicaltrials.gov).
authors.affiliation: Departments of Surgery, Bispebjerg Hospital, Copenhagen.
authors.forename: L N
authors.initials: LN
authors.lastname: Jørgensen
authors.forename: J
authors.initials: J
authors.lastname: Rosenberg
authors.forename: H
authors.initials: H
authors.lastname: Al-Tayar
authors.forename: S
authors.initials: S
authors.lastname: Assaadzadeh
authors.forename: F
authors.initials: F
authors.lastname: Helgstrand
authors.forename: T
authors.initials: T
authors.lastname: Bisgaard
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects / Q000379:methods*; D041761:Cholecystolithiasis / Q000601:surgery*; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008875:Middle Aged; D061646:Operative Time; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control; D020250:Postoperative Nausea and Vomiting / Q000209:etiology; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid