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How should single-access or natural orifice cholecystectomy be introduced?

2010; Elsevier BV; Volume: 12; Issue: 7 Linguagem: Inglês

10.1111/j.1477-2574.2010.00208.x

1477-2574

Saxon Connor,

Pancreatic and Hepatic Oncology Research

At the recent International Hepato-Pancreato-Biliary Association (IHPBA) world congress in Buenos Aires, numerous presentations1.You Y.K. Lee S.K. Hong T.H. Lee K.H. Park J.H. Yoon Y.C. Single-port laparoscopic cholecystectomy: comparative study in initial 106 cases.HPB. 2010; 12: 60Google Scholar, 2.Ferreres A.R. Rondan A. Gimenez M.E. Gutierrez V.P. Attaining the critical view of safety in single-incision laparoscopic cholecystectomy.HPB. 2010; 12: 104Google Scholar, 3.Chang S.K.Y. Tay C.W. Bicol R.A. Lee Y.Y. Madhavan K. Single-incision laparoscopic cholecystectomy: the first comparative study of postoperative pain with the standard laparoscopic cholecystectomy.HPB. 2010; 12: 105Google Scholar, 4.Lawenko M. Lee-Ong A. Lopez-Gutierrez J. Chan S. Ganpathi I.S. Lomanto D. Prospective observational study of single-port cholecystectomy vs. standard laparoscopic cholecystectomy.HPB. 2010; 12: 106Google Scholar, 5.Matteotti R. Chouillard E. Rassi W.E. Gumbs A.A. Single-incision cholecystectomy using gel port device.HPB. 2010; 12: 133Google Scholar, 6.Almau H. Mejias J. Arellano J. De La Fuente R. Garcia N. Henrandez J. NOTES: transvaginal cholecystectomy video-assisted, with common laparoscopic instruments, preliminary results.HPB. 2010; 12: 355Google Scholar, 7.Pellegrino Falcone A. Taronna La Torre I. Without scar: transumbilical laparoscopy cholecystectomy technique for single incision.HPB. 2010; 12: 357Google Scholar, 8.Shivaram H.V. Single-incision laparoscopic cholecystectomy: is it possible using conventional laparoscopic instruments.HPB. 2010; 12: 357Google Scholar, 9.Srikanth G. Shetty N. Prasad Babu T.L.V.D. Sikora S.S. Single-incision laparoscopic cholecystectomy without the use of a single-port device.HPB. 2010; 12: 453Google Scholar, 10.Starkov Y. Shishin K. Solodina E. Domarev L. Nedoluzhko L. Dzhantukhanova S. Endoscopic transumbilical and transvaginal cholecystectomy using various types of flexible endoscopes, including R scope.HPB. 2010; 12: 457Google Scholar, 11.Park I.L. Sohn B.S. Kim S.J. Lee S.K. Kim K.H. You Young K.Y. Laparoscopic cholecystectomy via a transvaginal approach – hybrid NOTES cholecystectomy.HPB. 2010; 12: 457Google Scholar addressed various aspects of single-port access or natural orifice endoscopic cholecystectomy. The largest series is of particular importance in that this study of 106 patients undergoing single-port cholecystectomy reported a bile duct injury.1.You Y.K. Lee S.K. Hong T.H. Lee K.H. Park J.H. Yoon Y.C. Single-port laparoscopic cholecystectomy: comparative study in initial 106 cases.HPB. 2010; 12: 60Google Scholar Surprisingly, the authors' conclusions are similar to those of authors reporting other smaller series: namely, that this procedure is safe.1.You Y.K. Lee S.K. Hong T.H. Lee K.H. Park J.H. Yoon Y.C. Single-port laparoscopic cholecystectomy: comparative study in initial 106 cases.HPB. 2010; 12: 60Google Scholar, 4.Lawenko M. Lee-Ong A. Lopez-Gutierrez J. Chan S. Ganpathi I.S. Lomanto D. Prospective observational study of single-port cholecystectomy vs. standard laparoscopic cholecystectomy.HPB. 2010; 12: 106Google Scholar, 5.Matteotti R. Chouillard E. Rassi W.E. Gumbs A.A. Single-incision cholecystectomy using gel port device.HPB. 2010; 12: 133Google Scholar These reports raise a number of issues. Patient selection was not often apparent, but it seemed evident that only uncomplicated gallbladder disease was reported. Several variations in technique were described, which suggests a lack of standardization; variations included differences in access points and instruments used. Lawenko et al.4.Lawenko M. Lee-Ong A. Lopez-Gutierrez J. Chan S. Ganpathi I.S. Lomanto D. Prospective observational study of single-port cholecystectomy vs. standard laparoscopic cholecystectomy.HPB. 2010; 12: 106Google Scholar compared seven patients undergoing single-port cholecystectomy with an identical number undergoing conventional laparoscopic cholecystectomy. Operating time in the former was almost twice that of the standard procedure (114 min vs. 68 min; P= 0.001) and there was no difference in hospital stay. You et al.1.You Y.K. Lee S.K. Hong T.H. Lee K.H. Park J.H. Yoon Y.C. Single-port laparoscopic cholecystectomy: comparative study in initial 106 cases.HPB. 2010; 12: 60Google Scholar have, however, shown a learning curve with this procedure and so this difference in operating time may diminish as experience accumulates. Chang et al.3.Chang S.K.Y. Tay C.W. Bicol R.A. Lee Y.Y. Madhavan K. Single-incision laparoscopic cholecystectomy: the first comparative study of postoperative pain with the standard laparoscopic cholecystectomy.HPB. 2010; 12: 105Google Scholar performed a similar comparative study and measured outcomes in terms of pain and time taken to return to normal activities. They found no difference in pain scores, but the single-port group returned to work 1.7 days earlier. However, in many other countries, this type of elective surgery is undertaken on a day case basis and it seems unreasonable to use length of hospital stay or return to work as outcome measures. Interestingly, these studies made no objective assessment of cosmetic outcome, which would seem to be one of the prime considerations in the decision to submit to the procedure. These studies raise several critical issues for the profession of surgery. It is almost three decades since the ad hoc introduction of laparoscopic cholecystectomy into surgical practice led to a significant increase in bile duct injuries.12.Fletcher D.R. Hobbs M.S. Tan P. Valinsky L.J. Hockey R.L. Pikora T.J. Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a population-based study.Ann Surg. 1999; 229: 449-457Crossref PubMed Scopus (441) Google Scholar, 13.Cohen M.M. Young W. Theriault M.E. Hernandez R. Has laparoscopic cholecystectomy changed patterns of practice and patient outcome in Ontario?.CMAJ. 1996; 154: 491-500PubMed Google Scholar, 14.Russell J.C. Walsh S.J. Mattie A.S. Lynch J.T. Bile duct injuries, 1989–1993. A statewide experience. Connecticut Laparoscopic Cholecystectomy Registry.Arch Surg. 1996; 131: 382-388Crossref PubMed Scopus (197) Google Scholar, 15.Richardson M.C. Bell G. Fullarton G.M. Incidence and nature of bile duct injuries following laparoscopic cholecystectomy: an audit of 5913 cases. West of Scotland Laparoscopic Cholecystectomy Audit Group.Br J Surg. 1996; 83: 1356-1360Crossref PubMed Scopus (271) Google Scholar, 16.Flum D.R. Dellinger E.P. Cheadle A. Chan L. Koepsell T. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy.JAMA. 2003; 289: 1639-1644Crossref PubMed Scopus (375) Google Scholar This is a devastating complication for patient, society and surgeon. In particular, the patient pays a huge price in terms of both quality and duration of life, with an average reduction in life expectancy of 9 years.17.Flum D.R. Cheadle A. Prela C. Dellinger E.P. Chan L. Bile duct injury during cholecystectomy and survival in Medicare beneficiaries.JAMA. 2003; 290: 2168-2173Crossref PubMed Scopus (394) Google Scholar Although the incidence of bile duct injury may be considered low, Flum et al.17.Flum D.R. Cheadle A. Prela C. Dellinger E.P. Chan L. Bile duct injury during cholecystectomy and survival in Medicare beneficiaries.JAMA. 2003; 290: 2168-2173Crossref PubMed Scopus (394) Google Scholar reported rates as high as one in 200 patients undergoing cholecystectomy (7911 in 1 570 361 procedures); thus, the prevalence is high given the frequency with which cholecystectomy is performed. Thus, any subtle change to the underlying incidence can have significant effects on its prevalence. There is an onus on the surgical profession to ensure that any new procedures are introduced in such a way that patients are not put at increased risk for serious complications. Large series will struggle to determine the safety of these new techniques, given the low incidence of bile duct injury. Furthermore, randomized trials will need to include so many patients that the costs and practicalities of performing such studies will prove prohibitive. However, alternative strategies exist, such as the establishing of a mandatory national or international database to which statistical process control methodology could be applied.18.Yap C.-.H. Colson M.E. Watters D.A. Cumulative sum techniques for surgeons: a brief review.ANZ J Surg. 2007; 77: 583-586Crossref PubMed Scopus (102) Google Scholar Thus, rather than measuring the incidence of bile duct injury (when disaster has already occurred), a safety checklist can be designed to ensure the critical view19.Hugh T.B. New strategies to prevent laparoscopic bile duct injury – surgeons can learn from pilots.Surgery. 2002; 132: 826-835Abstract Full Text Full Text PDF PubMed Scopus (185) Google Scholar is achieved safely by establishing a set of criteria to be fulfilled. Any decrease in frequency with which this was achieved could subsequently be detected prior to an increase in the incidence of bile duct injury. Ferreres et al.2.Ferreres A.R. Rondan A. Gimenez M.E. Gutierrez V.P. Attaining the critical view of safety in single-incision laparoscopic cholecystectomy.HPB. 2010; 12: 104Google Scholar have adopted a similar approach and should be congratulated on their efforts. They describe 60 single-incision laparoscopic cholecystectomies in which the procedure was recorded and reviewed by independent observers. The primary endpoint was safe dissection and display of the critical view within Calot's triangle. Of the 60 patients reported, the critical view was obtained in 55 (91.7%) patients. This demonstration that the critical view can be attained is paramount to the safe introduction of this technique and the prevention of bile duct injuries. Modern technology and the creation of web-based repositories for the submission of recorded procedures would allow for the subsequent review and assessment of predefined criteria by independent observers. So who is responsible for regulating the introduction of this new technology? Several institutions, bodies and professional societies may need to consider their role in ensuring that new technology is rolled out safely. Should industry ensure that new technologies are safe by mandating the compulsory reporting of predetermined outcomes to be overseen by independent data assessment committees? Should ethical committees ensure that adequate consideration has been given to both the power of studies and the proposed primary endpoint such that meaningful interpretation of results is possible? Given that the apparent benefit of this new technique would seem to be only cosmetic, it is important that patients are aware of what a small increase in the risk for bile duct injury implies and what the likely benefit of the new procedure actually is. Therefore, do prospective investigators need to reflect on how they intend to obtain informed consent from patients for small studies? An IHPBA position statement on how the development of this technology should be introduced and monitored should also be given consideration. Failure to address this issue risks the credibility of the profession with the public if history is repeated. None declared.