Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial

J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.


Background: Laparoscopy through a single umbilical incision is an emerging technique supported by case series, but prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing single site umbilical laparoscopic cholecystectomy to 4-port laparoscopic cholecystectomy.

Methods: After IRB approval, patients were randomized to laparoscopic cholecystectomy via a single umbilical incision or standard 4-port access. The primary outcome variable was operative time. Utilizing a power of 0.8 and an alpha of 0.05, 30 patients were calculated for each arm. Patients with complicated disease or weight over 100 kg were excluded. Post-operative management was controlled. Surgeons subjectively scored degree of technical difficulty from 1=easy to 5=difficult.

Results: From 8/2009 through 7/2011, 60 patients were enrolled. There were no differences in patient characteristics. Operative time and degree of difficulty were greater with the single site approach. There were more doses of analgesics used and greater hospital charges in the single site group that trended toward significance.

Conclusion: Single site laparoscopic cholecystectomy produces longer operative times with a greater degree of difficulty as assessed by the surgeon. There was a trend toward more doses of post-operative analgesics and greater hospital charges with the single site approach.

Trial registration: NCT00981604.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Cholecystectomy, Laparoscopic / methods*
  • Female
  • Gallbladder Diseases / surgery*
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Operative Time
  • Pain, Postoperative / etiology
  • Prospective Studies
  • Treatment Outcome

Associated data