Dennis Leung, MS, Woody Denham, MD, Mohammad Salabat, MD, Zeeshan Butt, PhD, Ermilo Barrera, MD, Michael Ujiki, MD. NorthShore University HealthSystem, Chicago, IL.
Introduction: Single-incision laparoscopic surgery was developed with the aim of decreasing post-operative pain and improving cosmesis. Several retrospective studies have shown feasibility of the technique; however, randomized trials comparing single-incision to multiple-incision laparoscopic surgery are lacking. We report a prospective randomized single-blinded trial comparing single-incision to multi-incision laparoscopic cholecystectomy.
Methods: After obtaining Institutional Review Board approval, patients with chronic cholecystitis, acute cholecystitis, or biliary dyskinesia were offered participation in this multi-hospital, multi-surgeon trial. A computer randomization program placed consenting patients in either a transumbilical single-incision (SI) or standard multi-incision (MI) group. Baseline quality of life and pain scores were obtained prior to surgery. Four dressings were placed in order to blind patients to their operation for one week. Patients were asked to complete pain and quality of life scores as well as record analgesic use throughout the post-operative period. Patients were followed for one year postoperatively.
Results: Over a one year period, 49 patients (26 SI) participated. Operating time was significantly less in the MI group (MI 34.8 vs. SI 69.2mins, p<0.0001). Blood loss was no different (MI 22.5 ± 36.6 vs. SI 16.3 ± 30.2mls, p=0.26) and there were no complications in either group. Post-operative pain scores and analgesic use were no different. Length of stay and return to work were similar. Return to daily activities was significantly longer in the SI group (MI 4.9 vs. SI 7.4 days, p=0.025). Post-operative quality of life scores were equivalent for fatigue (MI 13.68 ± 6.299 vs. SI 15.14 ± 4.565), pain (MI 8.53 ± 4.659 vs. SI 8.57 ± 3.025), and physical function (MI 33.5 ± 4.004 vs. SI 33.25 ± 3.683). Average follow-up was equivalent (MI 99.8 ± 99.6 vs. SI 90.2 ± 104.1 days, p=0.37).
Conclusions: Single-incision laparoscopic cholecystectomy results in longer operative time with similar post-operative pain and quality of life scores.
Program Number: P019