- Email: [email protected]
Credentialing for Laparoscopic Bowel Operation: There Is No Substitute for Knowing the Outcomes
Credentialing for Laparoscopic Bowel Operation: There Is No Substitute for Knowing the Outcomes Neil Hyman, MD, FACS, Edward Borrazzo, MD, FACS, Gino Trevisani, MD, FACS, Turner Osler, MD, FACS, Steven Shackford, MD, FACS Case volume and training have been considered as reasonable surrogates for competency that can be used as a basis to grant privileges for performing laparoscopic operations. To determine the validity of this practice, we assessed the relationship of surgical volume and training to provider-related complications after laparoscopic bowel resection. STUDY DESIGN: All patients undergoing open or laparoscopic resection at a university hospital from July 2003 to June 2006 were entered into a prospectively maintained database. Complications were recorded by a specially trained nurse practitioner and adjudicated monthly by a team of gastrointestinal surgeons. Surgeon case volume, training, and operative indication were assessed for their ability to predict technical complications after laparoscopic resection using a logistic regression model. RESULTS: Six hundred twenty-four bowel resections were performed during the study period, of which 112 were performed laparoscopically. Of the four study surgeons, the percentage of laparoscopic versus open cases ranged from 8% to 56%. Individual surgeon complication rates varied from 9% to 47%. Surgical volume and training had no notable relationship to incidence of complications (19% high volume/fellowship training versus 10% low volume/no fellowship, p ⫽ 0.25). An inflammatory indication was a strong predictor of technical complications on univariate (p ⫽ 0.02) and multivariate (p ⫽ 0.01) analysis. CONCLUSIONS: Surgeon case volume and training had no relationship to the complication rate after laparoscopic bowel operation. Case selection is a critical confounding variable because surgeons vary so greatly in their indications for using laparoscopic technique. Although documentation of training is appropriately considered in granting privileges, actually tracking outcomes is likely the only reliable way to assess competency. (J Am Coll Surg 2007;205:576–580. © 2007 by the American College of Surgeons) BACKGROUND:
sought to assess the validity of these factors as predictors of provider-related surgical complications.
Numerous case series have been published attesting to the safety of laparoscopic colectomy in expert hands.1-8 Laparoscopic bowel resection (LR) is a complex procedure with a formidable learning curve.9-12 It is uncertain whether most surgeons have the necessary volume and training required to achieve and maintain technical proficiency, highlighting the difficulties inherent in responsible credentialing for these procedures. Surgical case volume and training are often used as convenient surrogates for competency that can be used to certify or grant credentials to surgeons seeking to perform LR.13,14 We
METHODS All patients undergoing open or LR at Fletcher Allen Health Care, the teaching hospital of the University of Vermont College of Medicine, from July 2003 through June 2006, were entered into a prospectively maintained database. This included all elective and urgent resections of the small and large bowel with anastomosis (laparoscopic CPT codes 44202, 44204, 44205, and 44207 and open CPT codes 44120, 44140, 44145, and 44160). Patients whose operations involved creation or closure of a stoma were excluded. Operations performed by four gastrointestinal surgeons on the same surgical service were selected for review. A single nurse practitioner rounded daily on these patients with surgical housestaff and recorded all complications as they were detected. Complications were explic-
Competing Interests Declared: None. Received February 28, 2007; Revised May 16, 2007; Accepted May 21, 2007. From the Department of Surgery, University of Vermont College of Medicine, Fletcher Allen Health Care, Burlington, VT. Correspondence address: Neil Hyman, MD, FACS, Medical Center Hospital of Vermont, Department of Surgery, Fletcher 301, University of Vermont College of Medicine, 111 Colchester Ave, Burlington, VT 05401. email: [email protected]
© 2007 by the American College of Surgeons Published by Elsevier Inc.
576
ISSN 1072-7515/07/$32.00 doi:10.1016/j.jamcollsurg.2007.05.022
Vol. 205, No. 4, October 2007
Hyman et al
Credentialing for Laparoscopic Bowel Operation
577
Table 1. Laparoscopic Versus Open Resection by Surgeon
Surgeon
1 2 3 4 Total
Laparoscopic cases
Advanced laparoscopic training?
Y Y N N
Open cases
Total
n
%
n
%
n
%
34 49 17 11 111
56 54 19 8 29
27 42 74 130 273
44 46 81 92 71
61 91 91 141 384
100 100 100 100 100
N, no; Y, yes.
itly defined and the nurse practitioner had been trained in the application of these definitions as has been described previously.15 Monthly meetings of surgical attendings, housestaff, and the nurse practitioner were held to review complications and verify data accuracy. Surgical indications were noted and ultimately divided into three categories: benign (usually endoscopically unresectable polyps), malignant (usually colorectal cancer), or inflammatory (usually diverticulitis or Crohn’s disease). To be considered as a laparoscopic resection, the bowel had to be mobilized intracorporeally. Mesenteric division and anastomosis were performed intracorporeally or extracorporeally, based on surgeon preference. Individual surgeon volume and complications for each of the categories were noted. One of the surgeons had completed a fellowship in advanced laparoscopy and another had completed a colorectal fellowship in a program with considerable laparoscopic exposure. Both had performed more than 30 laparoscopic cases during the study period and their outcomes were grouped together (high-volume/fellowship trained). The two remaining surgeons had completed colon and rectal fellowships when laparoscopic resection was not being offered and each performed fewer than 20 cases during the study period. Their outcomes were also combined (lowvolume/nonfellowship trained). Univariate analysis (Fisher’s exact test) was used to evaluate the relationship between surgeon type (high-volume/ fellowship-trained laparoscopic versus low-volume/ nonlaparoscopic fellowship-trained) and occurrence of any complication and the distribution of surgical indications (ie, benign, malignant, inflammatory) by surgeon type. Multivariate logistic regression analysis with cluster (surgeon) correction was performed to determine the relative
contributions of volume/training and surgical indication on the incidence of postoperative technical complications.
RESULTS Six hundred twenty-four patients underwent bowel resection with anastomosis at Fletcher Allen Health Care during the 3-year study period. Three hundred eighty-six of these were performed by one of the four gastrointestinal surgeons and serve as the basis for this analysis. One hundred eleven (28.9%) of these resections were performed laparoscopically. The percentage of resections performed laparoscopically varied from 8% to 56% among the study surgeons. Fellowship-trained laparoscopic surgeons performed more than half of their resection laparoscopically (Table 1) and had a much higher distribution of inflammatory indications (Table 2). Fellowship-trained surgeons performed only 51% of the LR for benign disease, but they performed 91% of the LR for inflammatory indications (p ⬍ 0.0001 compared with nonfellowship-trained surgeons). There were 94 patients with complications in the open group (34.4%), and 37 patients with complications in the laparoscopic group (33.3%). Overall complication rate by surgeon for open and laparoscopic cases combined ranged from 30.5% to 43.9% (p ⫽ 0.17). Of the 43 total complications in the laparoscopic group, 19 were deemed to be technical complications (Table 3). Three of the complications required conversion to open operation, two in the fellowship-trained group. The technical complication rate varied notably by operative indication (Table 4); inflammatory conditions were associated with a markedly increased incidence of operative complications (28% versus 3%; p ⫽ 0.02). Overall
Table 2. Indication for Laparoscopic Resection Based on Fellowship Training Indication
n
Fellowship trained %
Nonfellowship-trained n %
n
%
Benign Malignant Inflammatory
18 26 39
51 79 91
17 7 4
35 33 43
100 100 100
49 21 9
Total
578
Hyman et al
Credentialing for Laparoscopic Bowel Operation
J Am Coll Surg
Table 3. Complications after Laparoscopic Bowel Resection (n ⫽ 111)
Table 4. Technical Complications by Surgical Indication
Complications
Benign Malignant Inflammatory
Technical Anastomotic leak Wound infection Intraperitoneal bleeding Inadvertent enterotomy Stapler misfiring Trocar-site bleeding Total Other Urinary retention/infection Arrhythmia Atelectasis Drug reaction Myocardial infection Pneumonia Small bowel obstruction Other Total
n
6 4 4 3 1 1 19 7 4 3 2 1 1 1 5 24
complication rate for LR varied from 9% to 47% among the study surgeons. Technical complication rate varied from 0% to 30%. Technical complication rate for the high-volume/fellowship-trained surgeons was 19%, versus 10% for the low-volume/nonfellowship-trained surgeons (p ⫽ 0.25). A multivariate logistic regression analysis with cluster correction (individual surgeon) demonstrated inflammatory indication to be a powerful predictor of technical complication after laparoscopic resection (p ⫽ 0.01), and surgeon volume/ training failed to be predict these complications (p ⫽ 0.77).
DISCUSSION Laparoscopic bowel resection in expert hands has been shown to be safe and effective, with outcomes at least as good as open operation for selected indications.16-22 Laparoscopic colectomy has been associated with less pain, improved cosmesis, and shorter length of stay.23-25 The potential benefits of LR would clearly not be sufficient to justify an increase in life-threatening complications, such as anastomotic leak, major hemorrhage, or recurrent cancer that could occur in inexperienced hands. Laparoscopic bowel operation is a technically complex procedure that can be challenging from many perspectives. “Resection requires mobilization of a bulky structure, working in more than one quadrant of the abdomen, obtaining control of multiple large vessels, extraction of a large specimen and creation of a safe anastomosis, as noted in the Guidelines for Laparoscopic Resection of Curable Colon
Total
Complications
%
p Value
35 33 43
1 6 12
3 18 28
— 0.09 0.02
and Rectal Cancer, endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons and the American Society of Colon and Rectal Surgeons.”26 A learning curve of 30 to 50 laparoscopic cases has been suggested.9-13 A study examining the operative experience of recertifying general surgeons demonstrated that the mean number of partial colectomies performed on an annual basis was 11.27 It seems doubtful that most surgeons in practice would have the volume necessary to achieve and maintain competence in laparoscopic bowel operation. Rigorous and reliable credentialing is likely an important component of assuring patient safety. Our data demonstrate the complexities and nuances of assessing competency for laparoscopic bowel resection. The most potent predictor of a surgical complication was the indication for operation; specifically, resections performed for inflammatory disease processes had a higher technical complication rate than those performed for benign disease. Indeed, it seems intuitive that bleeding or conversion to an open procedure is more likely when an ileocolic resection is performed for recurrent Crohn’s disease with a thickened, foreshortened mesentery than for an endoscopically unresectable cecal polyp. Similarly, a sigmoid resection for an early cancer is more straightforward than a resection for multiple recurrent diverticulitis with phlegmon and a colovesicle fistula. In our series, surgeons who were fellowship-trained in advanced laparoscopic bowel operation performed most of their resections laparoscopically. The other two surgeons, who completed a colon and rectal fellowship before the advent of laparoscopic resection, performed a much smaller percentage of their cases laparoscopically. They typically performed laparoscopic resection on what they perceived to be “easier” cases (most often an endoscopically unresectable polyp) and either referred more complex cases to the laparoscopic surgeons or performed them using open technique. What does all this mean with respect to credentialing for laparoscopic bowel operation? The surgeon with the highest volume of colectomies performed only 9% laparoscopically, but had no technical complications. Because this surgeon performed only 11 laparoscopic cases during the 3-year study period, an almost certainly inadequate volume to be considered an “expert,” should privileges for laparoscopic operation be denied? Or, should we conclude from the good outcomes that this surgeon knows his limitations
Vol. 205, No. 4, October 2007
Hyman et al
with respect to LR, can be trusted to be selective in its application and perform it safely? Should the highvolume of open cases or completion of a colorectal fellowship somehow be considered to contribute to competency for LR? On the other hand, surgeons with the highest volume and highest percentage of laparoscopic resections had the highest complication rate. It is clear from multivariate analysis that this was related to their willingness to perform difficult cases laparoscopically; these surgeons did not have a higher complication rate for the “easier” cases. Certainly, looking at complication rates out of context would have led to some very misleading conclusions. The increased volume of difficult cases performed by these surgeons can be attributable to referrals from peers who perceive that these are highly skilled and competent laparoscopic surgeons. Using the complication rate alone as a basis for granting laparoscopic privileges might deny patients access to the best laparoscopic surgeons. Considering the complexities of modern practice and referral patterns, it is uncertain whether our experience can be generalized to other practice settings. Nonetheless, examining surgical volume, training, or crude complication rates without thoughtful scrutiny and careful analysis can have undesirable consequences for surgical practice and patient care. It seems clear that volume and training in isolation are inadequate surrogates for assessing competency to perform LR. In addition, complication rate without considering case complexity is also inappropriate. It is important to know the mix of cases the surgeon is performing both laparoscopically and open, because the indication for operation appears to be the single most important predictor of operative complications. A structured concurrent analysis of consecutive cases, whether done open or laparoscopically, is required. Each institution must track and carefully review their outcomes to assess and improve surgical practice and assure patient safety. Author Contributions
Study conception and design: Hyman, Borrazzo, Trevisani Acquisition of data: Hyman, Shackford Analysis and interpretation of data: Osler Drafting of manuscript: Hyman Critical revision: Borrazzo, Trevisani, Shackford
REFERENCES 1. Hoffman GC, Baker JW, Fitchett CW, Vansant JH. Laparoscopicassisted colectomy. Initial experience. Ann Surg 1994;219:732– 743.
Credentialing for Laparoscopic Bowel Operation
579
2. Franklin ME Jr, Rosenthal D, Abrego-Medina D, et al. Prospective comparison of open vs. laparoscopic colon surgery for carcinoma. Five-year results. Dis Colon Rectum 1996;39:S35–46. 3. Bouvet M, Mansfield PF, Skibber JM, et al. Clinical, pathologic, and economic parameters of laparoscopic colon resection for cancer. Am J Surg 1998;176:554–558. 4. Khalili TM, Fleshner PR, Hiatt JR, et al. Colorectal cancer: comparison of laparoscopic with open approaches. Dis Colon Rectum 1998;41:832–838. 5. Santoro E, Carlini M, Carboni F, Feroce A. Colorectal carcinoma: laparoscopic versus traditional open surgery. A clinical trial. Hepatogastroenterology 1999;46:900–904. 6. Hong D, Tabet J, Anvari M. Laparoscopic vs. open resection for colorectal adenocarcinoma. Dis Colon Rectum 2001;44:10–18. 7. Patankar SK, Larach SW, Ferrara A, et al. Prospective comparison of laparoscopic vs. open resections for colorectal adenocarcinoma over a ten-year period. Dis Colon Rectum 2003;46: 601–611. 8. Duepree HJ, Senagore AJ, Delaney CP, Fazio VW. Does means of access affect the incidence of small bowel obstruction and ventral hernia after bowel resection? Laparoscopy versus laparotomy. J Am Coll Surg 2003;197:177–181. 9. Lezoche E, Feliciotti F, Paganini AM, et al. Laparoscopic vs. open hemicolectomy for colon cancer. Surg Endosc 2002;16: 596–602. 10. Senagore AJ, Luchtefeld MA, Mackeigan JM. What is the learning curve for laparoscopic colectomy? Am Surg 1995;61:681– 685. 11. Bennett CL, Stryker SJ, Ferreira MR, et al. The learning curve for laparoscopic colorectal surgery. Preliminary results from a prospective analysis of 1194 laparoscopic-assisted colectomies. Arch Surg 1997;132:41–45. 12. Simons AJ, Anthone GJ, Ortega AE, et al. Laparoscopic-assisted colectomy learning curve. Dis Colon Rectum 1995;38:600– 603. 13. Schlachta CM, Mamazza J, Gregoire R, et al. Predicting conversion in laparoscopic colorectal surgery. Fellowship training may be an advantage. Surg Endosc 2003;17:1288–1291. 14. Kuhry E, Bonjer HJ, Haglind E, et al. Impact of hospital case volume on short-term outcome after laparoscopic operation for colonic cancer. Surg Endosc 2005;19:687–692. 15. Healey MA, Shackford SR, Osler TM, et al. Complications in surgical patients. Arch Surg 2002;137:611–618. 16. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004;350:2050–2059. 17. Vukasin P, Ortega AE, Greene FL, et al. Wound recurrence following laparoscopic colon cancer resection. Results of the American Society of Colon and Rectal Surgeons Laparoscopic Registry. Dis Colon Rectum 1996;39:S20–S23. 18. Leung KL, Kwok SP, Lam SC, et al. Laparoscopic resection of rectosigmoid carcinoma: prospective randomised trial. Lancet 2004;363:1187–1192. 19. Monson JR, Darzi A, Carey PD, et al. Prospective evaluation of laparoscopic-assisted colectomy in an unselected group of patients. Lancet 1992;340:831–833. 20. Lacy AM, Garcia-Valdecasas JC, Delgado S, et al. Laparoscopyassisted colectomy versus open colectomy for treatment of nonmetastatic colon cancer: a randomised trial. Lancet 2002; 359:2224–2229. 21. Guillou PJ, Quirke P, Thorpe H, et al. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients
580
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Credentialing for Laparoscopic Bowel Operation
with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 2005;365:1718–1726. 22. Veldkamp R, Kuhry E, Hop WC, et al. Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 2005;6:477–484. 23. Braga M, Vignali A, Gianotti L, et al. Laparoscopic versus open colorectal surgery: a randomized trial on short-term outcome. Ann Surg 2002;236:759–766. 24. Liang JT, Shieh MJ, Chen CN, et al. Prospective evaluation of laparoscopy-assisted colectomy versus laparotomy with resec-
J Am Coll Surg
tion for management of complex polyps of the sigmoid colon. World J Surg 2002;26:377–383. 25. Weeks JC, Nelson H, Gelber S, et al. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs. open colectomy for colon cancer: a randomized trial. JAMA 2002;287:321–328. 26. Guidelines for laparoscopic resection of curable colon and rectal cancer. Available at: http://www.sages.org/sagespublication. php?doc⫽32. Accessed: November 1, 2006. 27. Hyman N. How much colorectal surgery do general surgeons do? J Am Coll Surg 2002;194:37–39.
JACS CME-1 PROGRAM 1.0 credit is earned for completing both questions for each article. Completion of all four articles (8 questions) earns 4 CME-1 credits each month.
www.jacscme.facs
sought to assess the validity of these factors as predictors of provider-related surgical complications.
Numerous case series have been published attesting to the safety of laparoscopic colectomy in expert hands.1-8 Laparoscopic bowel resection (LR) is a complex procedure with a formidable learning curve.9-12 It is uncertain whether most surgeons have the necessary volume and training required to achieve and maintain technical proficiency, highlighting the difficulties inherent in responsible credentialing for these procedures. Surgical case volume and training are often used as convenient surrogates for competency that can be used to certify or grant credentials to surgeons seeking to perform LR.13,14 We
METHODS All patients undergoing open or LR at Fletcher Allen Health Care, the teaching hospital of the University of Vermont College of Medicine, from July 2003 through June 2006, were entered into a prospectively maintained database. This included all elective and urgent resections of the small and large bowel with anastomosis (laparoscopic CPT codes 44202, 44204, 44205, and 44207 and open CPT codes 44120, 44140, 44145, and 44160). Patients whose operations involved creation or closure of a stoma were excluded. Operations performed by four gastrointestinal surgeons on the same surgical service were selected for review. A single nurse practitioner rounded daily on these patients with surgical housestaff and recorded all complications as they were detected. Complications were explic-
Competing Interests Declared: None. Received February 28, 2007; Revised May 16, 2007; Accepted May 21, 2007. From the Department of Surgery, University of Vermont College of Medicine, Fletcher Allen Health Care, Burlington, VT. Correspondence address: Neil Hyman, MD, FACS, Medical Center Hospital of Vermont, Department of Surgery, Fletcher 301, University of Vermont College of Medicine, 111 Colchester Ave, Burlington, VT 05401. email: [email protected]
© 2007 by the American College of Surgeons Published by Elsevier Inc.
576
ISSN 1072-7515/07/$32.00 doi:10.1016/j.jamcollsurg.2007.05.022
Vol. 205, No. 4, October 2007
Hyman et al
Credentialing for Laparoscopic Bowel Operation
577
Table 1. Laparoscopic Versus Open Resection by Surgeon
Surgeon
1 2 3 4 Total
Laparoscopic cases
Advanced laparoscopic training?
Y Y N N
Open cases
Total
n
%
n
%
n
%
34 49 17 11 111
56 54 19 8 29
27 42 74 130 273
44 46 81 92 71
61 91 91 141 384
100 100 100 100 100
N, no; Y, yes.
itly defined and the nurse practitioner had been trained in the application of these definitions as has been described previously.15 Monthly meetings of surgical attendings, housestaff, and the nurse practitioner were held to review complications and verify data accuracy. Surgical indications were noted and ultimately divided into three categories: benign (usually endoscopically unresectable polyps), malignant (usually colorectal cancer), or inflammatory (usually diverticulitis or Crohn’s disease). To be considered as a laparoscopic resection, the bowel had to be mobilized intracorporeally. Mesenteric division and anastomosis were performed intracorporeally or extracorporeally, based on surgeon preference. Individual surgeon volume and complications for each of the categories were noted. One of the surgeons had completed a fellowship in advanced laparoscopy and another had completed a colorectal fellowship in a program with considerable laparoscopic exposure. Both had performed more than 30 laparoscopic cases during the study period and their outcomes were grouped together (high-volume/fellowship trained). The two remaining surgeons had completed colon and rectal fellowships when laparoscopic resection was not being offered and each performed fewer than 20 cases during the study period. Their outcomes were also combined (lowvolume/nonfellowship trained). Univariate analysis (Fisher’s exact test) was used to evaluate the relationship between surgeon type (high-volume/ fellowship-trained laparoscopic versus low-volume/ nonlaparoscopic fellowship-trained) and occurrence of any complication and the distribution of surgical indications (ie, benign, malignant, inflammatory) by surgeon type. Multivariate logistic regression analysis with cluster (surgeon) correction was performed to determine the relative
contributions of volume/training and surgical indication on the incidence of postoperative technical complications.
RESULTS Six hundred twenty-four patients underwent bowel resection with anastomosis at Fletcher Allen Health Care during the 3-year study period. Three hundred eighty-six of these were performed by one of the four gastrointestinal surgeons and serve as the basis for this analysis. One hundred eleven (28.9%) of these resections were performed laparoscopically. The percentage of resections performed laparoscopically varied from 8% to 56% among the study surgeons. Fellowship-trained laparoscopic surgeons performed more than half of their resection laparoscopically (Table 1) and had a much higher distribution of inflammatory indications (Table 2). Fellowship-trained surgeons performed only 51% of the LR for benign disease, but they performed 91% of the LR for inflammatory indications (p ⬍ 0.0001 compared with nonfellowship-trained surgeons). There were 94 patients with complications in the open group (34.4%), and 37 patients with complications in the laparoscopic group (33.3%). Overall complication rate by surgeon for open and laparoscopic cases combined ranged from 30.5% to 43.9% (p ⫽ 0.17). Of the 43 total complications in the laparoscopic group, 19 were deemed to be technical complications (Table 3). Three of the complications required conversion to open operation, two in the fellowship-trained group. The technical complication rate varied notably by operative indication (Table 4); inflammatory conditions were associated with a markedly increased incidence of operative complications (28% versus 3%; p ⫽ 0.02). Overall
Table 2. Indication for Laparoscopic Resection Based on Fellowship Training Indication
n
Fellowship trained %
Nonfellowship-trained n %
n
%
Benign Malignant Inflammatory
18 26 39
51 79 91
17 7 4
35 33 43
100 100 100
49 21 9
Total
578
Hyman et al
Credentialing for Laparoscopic Bowel Operation
J Am Coll Surg
Table 3. Complications after Laparoscopic Bowel Resection (n ⫽ 111)
Table 4. Technical Complications by Surgical Indication
Complications
Benign Malignant Inflammatory
Technical Anastomotic leak Wound infection Intraperitoneal bleeding Inadvertent enterotomy Stapler misfiring Trocar-site bleeding Total Other Urinary retention/infection Arrhythmia Atelectasis Drug reaction Myocardial infection Pneumonia Small bowel obstruction Other Total
n
6 4 4 3 1 1 19 7 4 3 2 1 1 1 5 24
complication rate for LR varied from 9% to 47% among the study surgeons. Technical complication rate varied from 0% to 30%. Technical complication rate for the high-volume/fellowship-trained surgeons was 19%, versus 10% for the low-volume/nonfellowship-trained surgeons (p ⫽ 0.25). A multivariate logistic regression analysis with cluster correction (individual surgeon) demonstrated inflammatory indication to be a powerful predictor of technical complication after laparoscopic resection (p ⫽ 0.01), and surgeon volume/ training failed to be predict these complications (p ⫽ 0.77).
DISCUSSION Laparoscopic bowel resection in expert hands has been shown to be safe and effective, with outcomes at least as good as open operation for selected indications.16-22 Laparoscopic colectomy has been associated with less pain, improved cosmesis, and shorter length of stay.23-25 The potential benefits of LR would clearly not be sufficient to justify an increase in life-threatening complications, such as anastomotic leak, major hemorrhage, or recurrent cancer that could occur in inexperienced hands. Laparoscopic bowel operation is a technically complex procedure that can be challenging from many perspectives. “Resection requires mobilization of a bulky structure, working in more than one quadrant of the abdomen, obtaining control of multiple large vessels, extraction of a large specimen and creation of a safe anastomosis, as noted in the Guidelines for Laparoscopic Resection of Curable Colon
Total
Complications
%
p Value
35 33 43
1 6 12
3 18 28
— 0.09 0.02
and Rectal Cancer, endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons and the American Society of Colon and Rectal Surgeons.”26 A learning curve of 30 to 50 laparoscopic cases has been suggested.9-13 A study examining the operative experience of recertifying general surgeons demonstrated that the mean number of partial colectomies performed on an annual basis was 11.27 It seems doubtful that most surgeons in practice would have the volume necessary to achieve and maintain competence in laparoscopic bowel operation. Rigorous and reliable credentialing is likely an important component of assuring patient safety. Our data demonstrate the complexities and nuances of assessing competency for laparoscopic bowel resection. The most potent predictor of a surgical complication was the indication for operation; specifically, resections performed for inflammatory disease processes had a higher technical complication rate than those performed for benign disease. Indeed, it seems intuitive that bleeding or conversion to an open procedure is more likely when an ileocolic resection is performed for recurrent Crohn’s disease with a thickened, foreshortened mesentery than for an endoscopically unresectable cecal polyp. Similarly, a sigmoid resection for an early cancer is more straightforward than a resection for multiple recurrent diverticulitis with phlegmon and a colovesicle fistula. In our series, surgeons who were fellowship-trained in advanced laparoscopic bowel operation performed most of their resections laparoscopically. The other two surgeons, who completed a colon and rectal fellowship before the advent of laparoscopic resection, performed a much smaller percentage of their cases laparoscopically. They typically performed laparoscopic resection on what they perceived to be “easier” cases (most often an endoscopically unresectable polyp) and either referred more complex cases to the laparoscopic surgeons or performed them using open technique. What does all this mean with respect to credentialing for laparoscopic bowel operation? The surgeon with the highest volume of colectomies performed only 9% laparoscopically, but had no technical complications. Because this surgeon performed only 11 laparoscopic cases during the 3-year study period, an almost certainly inadequate volume to be considered an “expert,” should privileges for laparoscopic operation be denied? Or, should we conclude from the good outcomes that this surgeon knows his limitations
Vol. 205, No. 4, October 2007
Hyman et al
with respect to LR, can be trusted to be selective in its application and perform it safely? Should the highvolume of open cases or completion of a colorectal fellowship somehow be considered to contribute to competency for LR? On the other hand, surgeons with the highest volume and highest percentage of laparoscopic resections had the highest complication rate. It is clear from multivariate analysis that this was related to their willingness to perform difficult cases laparoscopically; these surgeons did not have a higher complication rate for the “easier” cases. Certainly, looking at complication rates out of context would have led to some very misleading conclusions. The increased volume of difficult cases performed by these surgeons can be attributable to referrals from peers who perceive that these are highly skilled and competent laparoscopic surgeons. Using the complication rate alone as a basis for granting laparoscopic privileges might deny patients access to the best laparoscopic surgeons. Considering the complexities of modern practice and referral patterns, it is uncertain whether our experience can be generalized to other practice settings. Nonetheless, examining surgical volume, training, or crude complication rates without thoughtful scrutiny and careful analysis can have undesirable consequences for surgical practice and patient care. It seems clear that volume and training in isolation are inadequate surrogates for assessing competency to perform LR. In addition, complication rate without considering case complexity is also inappropriate. It is important to know the mix of cases the surgeon is performing both laparoscopically and open, because the indication for operation appears to be the single most important predictor of operative complications. A structured concurrent analysis of consecutive cases, whether done open or laparoscopically, is required. Each institution must track and carefully review their outcomes to assess and improve surgical practice and assure patient safety. Author Contributions
Study conception and design: Hyman, Borrazzo, Trevisani Acquisition of data: Hyman, Shackford Analysis and interpretation of data: Osler Drafting of manuscript: Hyman Critical revision: Borrazzo, Trevisani, Shackford
REFERENCES 1. Hoffman GC, Baker JW, Fitchett CW, Vansant JH. Laparoscopicassisted colectomy. Initial experience. Ann Surg 1994;219:732– 743.
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