title: Randomized clinical trial of single-port, minilaparoscopic and conventional laparoscopic cholecystectomy.
abstract: BACKGROUND
  This three-armed randomized clinical trial, with blinding of patients and outcome assessors, tested the hypothesis that single-port (SP) and/or minilaparoscopic (ML) cholecystectomy are superior to conventional laparoscopic (CL) cholecystectomy.
  
  
  METHODS
  Patients eligible for elective laparoscopic cholecystectomy were randomized to SP, ML or CL procedures. The primary outcome was pain measured on a visual analogue scale twice daily during the blinded period. Secondary outcomes included duration of operation, technical performance score, complications, quality of life, cosmesis and patient satisfaction. Postoperative follow-up lasted 1 year.
  
  
  RESULTS
  A total of 105 patients were randomized, 35 in each group. One conversion from a SP to a CL technique was necessary in a patient with chronic cholecystitis. Pain intensity was similar in the three groups, both during the blinded period (day 0 to 3; P = 0·865) and over the whole 7-day evaluation period (P = 0·911). The presence of clinically relevant between-group differences was ruled out (95 per cent confidence interval + 1·0 to - 0·5 for difference in pain scores between SP and CL groups, and - 0·8 to + 0·6 between ML and CL groups). Operating time was significantly longer for SP and ML than for CL cholecystectomy (P = 0·001). Postoperative complications included injury to the diaphragm (1), choledocholithiasis (1), wound infection (5) and hernia (1), all after SP cholecystectomy (P = 0·001). Twelve-month follow-up was complete in 99 patients (94·3 per cent). Cosmesis as rated by patients was significantly better at 6 months after SP and ML procedures (P = 0·043), but no difference was observed at 12 months (P = 0·229).
  
  
  CONCLUSIONS
  SP and ML cholecystectomy had no advantage over the CL approach in terms of postoperative outcome.
  
  
  BACKGROUND
  DRKS00000302 (German Registry of Clinical Trials).
authors.affiliation: Department of General Surgery, Clinic Gummersbach, Academic Hospital University Cologne, Gummersbach, Germany. stefansaad@aol.com
authors.forename: S
authors.initials: S
authors.lastname: Saad
authors.forename: V
authors.initials: V
authors.lastname: Strassel
authors.forename: S
authors.initials: S
authors.lastname: Sauerland
mesh_terms: D000704:Analysis of Variance; D017081:Cholecystectomy, Laparoscopic / Q000379:methods*; D041761:Cholecystolithiasis / Q000601:surgery*; D002983:Clinical Competence / Q000592:standards; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology; D011788:Quality of Life; D016896:Treatment Outcome