- Email: [email protected]
How should single-access or natural orifice cholecystectomy be introduced?
HPB
DOI:10.1111/j.1477-2574.2010.00208.x
EDITORIAL
How should single-access or natural orifice cholecystectomy be introduced? Saxon J. Connor Department of Surgery, Christchurch Hospital, Christchurch, New Zealand
Correspondence Saxon J. Connor, Department of Surgery, Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand. Tel: + 64 3 364 0640. Fax: + 64 3 364 0352. E-mail: [email protected]
At the recent International Hepato-Pancreato-Biliary Association (IHPBA) world congress in Buenos Aires, numerous presentations1–11 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 Surprisingly, the authors’ conclusions are similar to those of authors reporting other smaller series: namely, that this procedure is safe.1,4,5 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 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 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 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.12–16 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
HPB 2010, 12, 437–438
life, with an average reduction in life expectancy of 9 years.17 Although the incidence of bile duct injury may be considered low, Flum et al.17 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 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 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 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
© 2010 International Hepato-Pancreato-Biliary Association
HPB
438
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.
with common laparoscopic instruments, preliminary results. HPB 12 (Suppl. 1):355. 7. Pellegrino Falcone A, Taronna La Torre I. (2010) Without scar: transumbilical laparoscopy cholecystectomy technique for single incision. HPB 12 (Suppl. 1):357. 8. Shivaram HV. (2010) Single-incision laparoscopic cholecystectomy: is it possible using conventional laparoscopic instruments. HPB 12 (Suppl. 1):357. 9. Srikanth G, Shetty N, Prasad Babu TLVD, Sikora SS. (2010) Single-incision laparoscopic cholecystectomy without the use of a single-port device. HPB 12 (Suppl. 1):453. 10. Starkov Y, Shishin K, Solodina E, Domarev L, Nedoluzhko L, Dzhantukhanova S et al. (2010) Endoscopic transumbilical and transvaginal cholecystectomy using various types of flexible endoscopes, including R scope. HPB 12 (Suppl. 1):457. 11. Park IL, Sohn BS, Kim SJ, Lee SK, Kim KH, You Young KY et al. (2010) Laparoscopic cholecystectomy via a transvaginal approach – hybrid NOTES cholecystectomy. HPB 12 (Suppl. 1):457. 12. Fletcher DR, Hobbs MS, Tan P, Valinsky LJ, Hockey RL, Pikora TJ et al. (1999) Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a
Conflicts of interest None declared.
population-based study. Ann Surg 229:449–457. 13. Cohen MM, Young W, Theriault ME, Hernandez R. (1996) Has laparoscopic cholecystectomy changed patterns of practice and patient
References
outcome in Ontario? CMAJ 154:491–500.
1. You YK, Lee SK, Hong TH, Lee KH, Park JH, Yoon YC et al. (2010)
14. Russell JC, Walsh SJ, Mattie AS, Lynch JT. (1996) Bile duct injuries,
Single-port laparoscopic cholecystectomy: comparative study in initial
1989–1993. A statewide experience. Connecticut Laparoscopic Chole-
106 cases. HPB 12 (Suppl. 1):60.
cystectomy Registry. Arch Surg 131:382–388.
2. Ferreres AR, Rondan A, Gimenez ME, Gutierrez VP. (2010) Attaining the
15. Richardson MC, Bell G, Fullarton GM. (1996) Incidence and nature of bile
critical view of safety in single-incision laparoscopic cholecystectomy.
duct injuries following laparoscopic cholecystectomy: an audit of 5913
HPB 12 (Suppl. 1):104.
cases. West of Scotland Laparoscopic Cholecystectomy Audit Group.
3. Chang SKY, Tay CW, Bicol RA, Lee YY, Madhavan K. (2010) Single-
Br J Surg 83:1356–1360.
incision laparoscopic cholecystectomy: the first comparative study of
16. Flum DR, Dellinger EP, Cheadle A, Chan L, Koepsell T. (2003) Intra-
postoperative pain with the standard laparoscopic cholecystectomy.
operative cholangiography and risk of common bile duct injury during
HPB 12 (Suppl. 1):105.
cholecystectomy. JAMA 289:1639–1644.
4. Lawenko M, Lee-Ong A, Lopez-Gutierrez J, Chan S, Ganpathi IS,
17. Flum DR, Cheadle A, Prela C, Dellinger EP, Chan L. (2003) Bile duct injury
Lomanto D. (2010) Prospective observational study of single-port
during cholecystectomy and survival in Medicare beneficiaries. JAMA
cholecystectomy vs. standard laparoscopic cholecystectomy. HPB 12 (Suppl. 1):106. 5. Matteotti R, Chouillard E, Rassi WE, Gumbs AA. (2010) Single-incision cholecystectomy using gel port device. HPB 12 (Suppl. 1):133. 6. Almau H, Mejias J, Arellano J, De La Fuente R, Garcia N, Henrandez J et al. (2010) NOTES: transvaginal cholecystectomy video-assisted,
HPB 2010, 12, 437–438
290:2168–2173. 18. Yap C-H, Colson ME, Watters DA. (2007) Cumulative sum techniques for surgeons: a brief review. ANZ J Surg 77:583–586. 19. Hugh TB. (2002) New strategies to prevent laparoscopic bile duct injury – surgeons can learn from pilots. Surgery 132:826– 835.
© 2010 International Hepato-Pancreato-Biliary Association
DOI:10.1111/j.1477-2574.2010.00208.x
EDITORIAL
How should single-access or natural orifice cholecystectomy be introduced? Saxon J. Connor Department of Surgery, Christchurch Hospital, Christchurch, New Zealand
Correspondence Saxon J. Connor, Department of Surgery, Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand. Tel: + 64 3 364 0640. Fax: + 64 3 364 0352. E-mail: [email protected]
At the recent International Hepato-Pancreato-Biliary Association (IHPBA) world congress in Buenos Aires, numerous presentations1–11 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 Surprisingly, the authors’ conclusions are similar to those of authors reporting other smaller series: namely, that this procedure is safe.1,4,5 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 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 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 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.12–16 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
HPB 2010, 12, 437–438
life, with an average reduction in life expectancy of 9 years.17 Although the incidence of bile duct injury may be considered low, Flum et al.17 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 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 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 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
© 2010 International Hepato-Pancreato-Biliary Association
HPB
438
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.
with common laparoscopic instruments, preliminary results. HPB 12 (Suppl. 1):355. 7. Pellegrino Falcone A, Taronna La Torre I. (2010) Without scar: transumbilical laparoscopy cholecystectomy technique for single incision. HPB 12 (Suppl. 1):357. 8. Shivaram HV. (2010) Single-incision laparoscopic cholecystectomy: is it possible using conventional laparoscopic instruments. HPB 12 (Suppl. 1):357. 9. Srikanth G, Shetty N, Prasad Babu TLVD, Sikora SS. (2010) Single-incision laparoscopic cholecystectomy without the use of a single-port device. HPB 12 (Suppl. 1):453. 10. Starkov Y, Shishin K, Solodina E, Domarev L, Nedoluzhko L, Dzhantukhanova S et al. (2010) Endoscopic transumbilical and transvaginal cholecystectomy using various types of flexible endoscopes, including R scope. HPB 12 (Suppl. 1):457. 11. Park IL, Sohn BS, Kim SJ, Lee SK, Kim KH, You Young KY et al. (2010) Laparoscopic cholecystectomy via a transvaginal approach – hybrid NOTES cholecystectomy. HPB 12 (Suppl. 1):457. 12. Fletcher DR, Hobbs MS, Tan P, Valinsky LJ, Hockey RL, Pikora TJ et al. (1999) Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a
Conflicts of interest None declared.
population-based study. Ann Surg 229:449–457. 13. Cohen MM, Young W, Theriault ME, Hernandez R. (1996) Has laparoscopic cholecystectomy changed patterns of practice and patient
References
outcome in Ontario? CMAJ 154:491–500.
1. You YK, Lee SK, Hong TH, Lee KH, Park JH, Yoon YC et al. (2010)
14. Russell JC, Walsh SJ, Mattie AS, Lynch JT. (1996) Bile duct injuries,
Single-port laparoscopic cholecystectomy: comparative study in initial
1989–1993. A statewide experience. Connecticut Laparoscopic Chole-
106 cases. HPB 12 (Suppl. 1):60.
cystectomy Registry. Arch Surg 131:382–388.
2. Ferreres AR, Rondan A, Gimenez ME, Gutierrez VP. (2010) Attaining the
15. Richardson MC, Bell G, Fullarton GM. (1996) Incidence and nature of bile
critical view of safety in single-incision laparoscopic cholecystectomy.
duct injuries following laparoscopic cholecystectomy: an audit of 5913
HPB 12 (Suppl. 1):104.
cases. West of Scotland Laparoscopic Cholecystectomy Audit Group.
3. Chang SKY, Tay CW, Bicol RA, Lee YY, Madhavan K. (2010) Single-
Br J Surg 83:1356–1360.
incision laparoscopic cholecystectomy: the first comparative study of
16. Flum DR, Dellinger EP, Cheadle A, Chan L, Koepsell T. (2003) Intra-
postoperative pain with the standard laparoscopic cholecystectomy.
operative cholangiography and risk of common bile duct injury during
HPB 12 (Suppl. 1):105.
cholecystectomy. JAMA 289:1639–1644.
4. Lawenko M, Lee-Ong A, Lopez-Gutierrez J, Chan S, Ganpathi IS,
17. Flum DR, Cheadle A, Prela C, Dellinger EP, Chan L. (2003) Bile duct injury
Lomanto D. (2010) Prospective observational study of single-port
during cholecystectomy and survival in Medicare beneficiaries. JAMA
cholecystectomy vs. standard laparoscopic cholecystectomy. HPB 12 (Suppl. 1):106. 5. Matteotti R, Chouillard E, Rassi WE, Gumbs AA. (2010) Single-incision cholecystectomy using gel port device. HPB 12 (Suppl. 1):133. 6. Almau H, Mejias J, Arellano J, De La Fuente R, Garcia N, Henrandez J et al. (2010) NOTES: transvaginal cholecystectomy video-assisted,
HPB 2010, 12, 437–438
290:2168–2173. 18. Yap C-H, Colson ME, Watters DA. (2007) Cumulative sum techniques for surgeons: a brief review. ANZ J Surg 77:583–586. 19. Hugh TB. (2002) New strategies to prevent laparoscopic bile duct injury – surgeons can learn from pilots. Surgery 132:826– 835.
© 2010 International Hepato-Pancreato-Biliary Association