This months expert is Dr. David Rattner from Massachusetts General Hospital. He is also a Professor of Surgery at Harvard Medical School. His summary of this article and questions for you to ponder follow.
Article Summary: Randomized Controlled Trial Comparing Single-Port Laparoscopic Cholecystectomy and Four-Port Laparoscopic Cholecystectomy. Authors: Ma J, Cassera M, Spaun GO, Hammill CW, Hansen PD, Aliabadi-Wahle S. Ann Surg 2011;254:22-27.
Ma and colleagues performed a prospective randomized trial comparing Single Port laparoscopic cholecystectomy (SPLC) with traditional Four-Port laparoscopic cholecstectomy (CLC). The study population included patients willing to submit to randomization who had appropriate indications for an elective laparoscopic cholecystectomy, BMI < 40 kg/m2, and no evidence pre-operatively of choledocholithiasis. The primary outcome was pain measured by a 10 point visual analogue scale administered at the time of discharge and at a follow up visit. Secondary outcomes included operative time, length of stay, post operative morbidity, Quality of Life measured by SF-36, as well as overall and cosmetic satisfaction.
This study demonstrated that patients undergoing SPLC had more pain at the time of discharge than those undergoing CLC although the difference did not quite reach statistical significance ( p = .06). At the time of the postoperative visit- more than 14 days post op- there was no difference in pain between the two groups of patients. SPLC provided neither higher overall patient satisfaction nor cosmetic satisfaction. The operative time for SPLC was significantly longer than CLC, but there was clear evidence of a learning curve effect. The mean operative time for SPLC declined from an average of 100 minutes in the first seven cases to 82 minutes in the last seven cases although this difference did not achieve statistical significance. The presence of a learning curve effect in this study is further supported by the need to use an additional instrument through a separate puncture site for gallbladder retraction more frequently in the earlier cases in this series. Patients undergoing SPLC sustained more complications including a port site hernia and post-operative port site hemorrhage. The authors provide no cost data. The authors conclude that “the potential superiority [of SPLC] and advantages over CLC still awaits examination by larger RCT’s.”
1) If you were the Chief Medical Officer of a health care organization at risk financially for providing surgical care to patients with gallbladder disease would you restrict the use of SPLC? If so, what criteria would you develop to determine the providers and patients that are best served by this technique?
2) Is it beneficial to perform “Single Port Surgery” if additional ports are sometimes required? What evidence exists demonstrating that using fewer trocars (5mm or less) is associated with better outcomes either in terms of pain or cosmesis for procedures other than cholecystectomy? Conversely, is there evidence of increased morbidity due to the use of too few trocars?
3) The authors of this series included patients with BMI>30 and also had performed relatively few SPLC prior to enrolling patients in this trial. If the same surgeons were required to have performed 25 SPLC in order to participate in the trial and patients with BMI>30 were excluded do you think the results of this trial would have been different? If so is there existing literature to support your point of view?
We hope you will find the Journal Club not only enlightening and engaging, but also entertaining and thoughtful. Of course, we look forward to hearing from you.
Layton F. Rikkers, M.D., Emeritus Editor-in-Chief