Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy

Br J Surg. 2011 Dec;98(12):1695-702. doi: 10.1002/bjs.7689. Epub 2011 Sep 30.


Background: Conventional laparoscopy with three or more ports remains the 'gold standard' for cholecystectomy, but a laparoendoscopic single-site (LESS) approach is emerging, designed to decrease parietal trauma and improve cosmesis. This study compared conventional laparoscopic (CL) with LESS cholecystectomy, with short-term clinical results as the main outcomes.

Methods: A randomized trial of CL and LESS cholecystectomies involving 150 patients was undertaken. Follow-up was for 1 month after surgery. The primary endpoint was body image results evaluated by means of validated scales. Secondary endpoints were: postoperative pain measured on a visual analogue scale, analgesia requirement, morbidity, quality of life (QoL) measured with Short Form 12, duration of operation, hospital stay, time to return to work and cost analysis.

Results: Operating times and complications were similar in the two groups. Two LESS procedures (3 per cent) were converted to two-port laparoscopy owing to difficulties with exposure, and one CL operation was achieved through a single port because extensive fibrous peritoneal adhesions prevented placement of other ports. There were three and four port-site seroma/haematomas in the LESS and CL groups respectively. Better pain profiles and lower analgesia requirements were recorded in the LESS group (P < 0·001). QoL, body image and scar scale results were also better (P < 0·001). Operative costs were higher for LESS procedures (P < 0·001), although median time to return to work was shorter (P = 0·003).

Conclusion: LESS is an alternative to CL cholecystectomy associated with better cosmesis, body image, QoL and an improved postoperative pain profile.

Trial registration: ClinicalTrials.gov NCT00904865.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Body Image
  • Cholecystectomy, Laparoscopic / economics
  • Cholecystectomy, Laparoscopic / methods*
  • Cholecystectomy, Laparoscopic / psychology
  • Cholecystitis / economics
  • Cholecystitis / psychology
  • Cholecystitis / surgery*
  • Female
  • Gallstones / economics
  • Gallstones / psychology
  • Gallstones / surgery*
  • Humans
  • Longevity
  • Male
  • Middle Aged
  • Pancreatitis / economics
  • Pancreatitis / surgery*
  • Postoperative Complications / economics
  • Postoperative Complications / etiology*
  • Postoperative Complications / psychology
  • Quality of Life
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT00904865