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Colonic Anastomotic Leak: Risk Factors, Diagnosis, and Treatment
1152
Letters
was cost-effective as measured by cost per CBDI avoided and by comparison with the estimated cost of a CBDI repair.2 Livingston and colleagues use the terms cost and charge interchangeably in their study and did not apply the standard charge-to-cost ratio (which is close to 0.5). This led to a doubling of the estimated “cost” of an IOC. When applying this standard ratio to the charges of an IOC in this article (⬃$700), the actual cost is closer to ⬃$300 to $350, falling well within the range of cost-effectiveness demonstrated in our study. The often quoted $100,000 to $300,000 estimate for cost of CBDI repair might be an underestimate of the true, current cost, for several reasons. First, these estimates are derived from studies more than a decade old. Second, ⬎90% of CBDI repairs performed at nonreferral centers will require an operative revision or additional nonoperative interventions,3,4 all of which will be additive to the total financial burden on the health care system as a whole. There has also been a proliferation of nonoperative, interventional approaches to CBDI with repeated stenting, dilation, and radiologic studies, all of which add to the cost of CBDI management. No recent study has evaluated total cost attributable to subsequent procedures and readmissions for complications arising from repair of a CBDI. All appropriately sized studies evaluating this issue support routine IOC.5 High-risk industries, such as aviation and nuclear power, became safer over time by consistently applying interventions that prevent even rare, catastrophic outcomes. IOC is a simple and relatively inexpensive intervention that can sometimes prevent severe CBDI. Following the example of other high-risk industries, the surgical community should create a safety culture where even rare events like CBDI are accounted for by better training and standard use of safety measures such as IOC.
REFERENCES 1. Livingston EH, Miller JA, Coan B, Rege RV. Costs and utilization of intraoperative cholangiography. J Gastrointest Surg 2007;11: 1162–1167. 2. Flum DR, Flowers C, Veenstra DL. A cost-effectiveness analysis of intraoperative cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy. J Am Coll Surg 2003;196:385–393. 3. Lillemoe KD, Martin SA, Cameron JL, et al. Major bile duct injuries during laparoscopic cholecystectomy. Follow-up after combined surgical and radiologic management. Ann Surg 1997; 225:459–471. 4. Woods MS, Traverso LW, Kozarek RA, et al. Characteristics of biliary tract complications during laparoscopic cholecystectomy: a multi-institutional study. Am J Surg 1994;167:27–34. 5. Massarweh NN, Flum DR. Role of intraoperative cholangiography in avoiding bile duct injury. J Am Coll Surg 2007;204: 656–664.
J Am Coll Surg
Colonic Anastomotic Leak: Risk Factors, Diagnosis, and Treatment Giuseppe Brisinda, MD, Serafino Vanella, MD, Federica Cadeddu, MD, Pasquale Mazzeo, MD Rome, Italy We read with interest the very excellent collective review by Kingham and Pachter.1 The authors have clearly identified risk factors contributing to intestinal anastomotic breakdown and delineate methods of diagnosis and treatment of this universally dreaded complication. Remarkable progress has been made in the treatment of rectal cancer. The main goal of rectal operations for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual and urinary function.1-6 Sphincter-saving procedures associated with partial or total mesorectal excision for the treatment of mid and distal rectal cancer have become increasingly prevalent because their safety and efficacy have been proved.3-5 Introduction of circular stapling devices is largely responsible for their increasing popularity and use. According to the authors, we believe that the incidence of anastomotic leak varies widely, depending on the anastomosis type and distance from the anal verge.1,6 In a recent study,6 early and late postoperative complications in 77 T1-T2 rectal cancer patients who underwent rectal resection with stapled end to end anastomosis or end to side anastomosis have been evaluated. Postoperative outcomes of the two procedures, clinicopathological features between patients with and without anastomotic leakage, have been compared. In 37 patients, an end to end anastomosis was performed and in 40 patients an end to side anastomosis was done. The overall incidence of anastomotic leakage was 16.8% (13 of 77 patients). Anastomotic leakage after end to end anastomosis was 29.2%, and after end to side anastomosis was 5% (p ⫽ 0.005). In the end to end group, 11 patients had anastomotic leaks: 9 patients needed a reintervention with colostomy creation; 2 patients were treated with local washouts and IV antibiotics. Two patients from the end to side group experienced anastomotic leakage and were successfully treated with local washouts and antibiotics for 6 weeks. Incomplete bowel preparation and blood transfusions were significantly related to the development of the anastomotic leakage. On the basis of the distal section of the rectum, we divided anastomosis in two groups: medium rectum anastomosis and low rectum anastomosis. Thirty-eight medium rectum anastomosis (18 end to end and 20 end to side) and 39 low rectum anastomosis (19 end to end and 20 end to side) were performed. Anastomotic level was significantly related (p ⫽ 0.001) to the leakage rate. Patients who
Vol. 208, No. 6, June 2009
underwent total mesorectal excision had a significantly higher leakage rate than patients who underwent partial mesorectal excision (30.7% versus 2.6%; p ⫽ 0.001). In this prospective study, outcomes were compared between end to end and end to side anastomosis in anterior resection with mesorectal excision for T1-T2 rectal cancer. The patients studied currently were those with a potentially resectable tumor without signs of spread and where restorative operation was deemed possible to perform. Patients were randomized at a late stage of operation. After a total mesorectal excision had been performed, and if there were no macroscopical signs of local residual disease, both methods had to be deemed possible to perform before randomization took place. The technique used to fashion a colorectal anastomosis is based largely on surgeon preference. To achieve an adequate anastomosis with a low rate of postoperative leak, certain basic surgical principles must be met.
REFERENCES 1. Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg 2009;208:269–278. 2. Rullier E, Laurent C, Bretagnol F, et al. Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg 2005;241:465–469. 3. Murphy J, Hammond TM, Knowles CH, et al. Does anastomotic technique influence anorectal function after sphincter-saving rectal cancer resection? A systematic review of evidence from randomized trials. J Am Coll Surg 2007;204:673–680. 4. Yeh CY, Changchien CR, Wang JY, et al. Pelvic drainage and other risk factors for leakage after elective anterior resection in rectal cancer patients: a prospective study of 978 patients. Ann Surg 2005;241:9–13. 5. den Dulk M, Smit M, Peeters KC, et al. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol 2007;8:297–303. 6. Brisinda G, Vanella S, Cadeddu F, et al. End-to-end versus endto-side stapled anastomosed after anterior resection for rectal cancer. J Surg Oncol 2009;99:75–79.
Reply T Peter Kingham, MD, H Leon Pachter, MD, FACS New York, NY We appreciate the commentary by Brisinda in reference to our review “Colonic Anastomotic Leak: Risk Factors, Diagnosis, and Treatment.”1 Their study, in which 77 patients with T1 or T2 rectal cancers were randomized to end to end anastomoses or end to side anastomoses provides some in-
Letters 1153
teresting data about stapling technique.2 Leak rates were significantly lower for end to side anastomoses (5%) compared with end to end anastomoses (29.2%; p ⫽ 0.005). In addition, there was a higher leak rate in low rectal anastomoses (31%), defined as ⬍8 cm from the anal verge, compared with mid-rectal anastomoses (3%; p ⫽ 0.001). Another important finding was the difference in reoperations, with 24% of the end to end anastomoses group requiring reoperation, compared with 0% of the end to side group (p ⫽ 0.0008). One of the striking results in Brisinda’s study is the large difference in leak rate between patients who underwent total mesorectal excision (TME; 30.7%) compared with partial mesorectal excision (2.6%; p ⫽ 0.001). Although TME is thought to have a higher complication rate, there is generally not as large a disparity as is seen in this study.3 Because of the improved clearance of lymphovascular tissue surrounding the rectum and decreased local recurrence rates, we advocate TME for low rectal cancers. As described in our review, proximal diversion does not prevent anastomotic leaks. Diversion does decrease the clinical sequelae of a leak.4 In the study presented by Brisinda and colleagues, no diverting ostomies were used, even in low anastomoses. Had they been used, they might have decreased the considerable reoperative rate in the group of patients with an anastomotic leak. Technical considerations that are of paramount importance in low rectal anastomoses include tension-free proximal and distal stumps with adequate blood supply. The technique we favor for low rectal anastomoses is an end to end circular stapled anastomosis, with a purse string only on the proximal colonic limb. It is not surprising that there was a considerably higher leak rate in the group labeled end to end in Brisinda’s study, where a purse string was applied to the rectal stump, because this can be technically challenging to perform in low rectal patients and in male patients. More specifically, we believe the rectum is at times too big and the purse string never really brings the bowel wall onto the shaft of the end-to-end anastomotic stapler, leaving small gaps that are high-risk areas for leaks. Because of this technique, the study by Brisinda and colleagues does not definitively answer the question about whether end to side anastomoses have fewer complications than end to end anastomoses. It is much preferred to perform end to end anastomoses without using a distal purse string, and we use this as our standard rectal anastomosis. We instead submit that the appropriate conclusion from their trial is that low rectal anastomoses should not incorporate a rectal stump purse string, unless an ana-
Letters
was cost-effective as measured by cost per CBDI avoided and by comparison with the estimated cost of a CBDI repair.2 Livingston and colleagues use the terms cost and charge interchangeably in their study and did not apply the standard charge-to-cost ratio (which is close to 0.5). This led to a doubling of the estimated “cost” of an IOC. When applying this standard ratio to the charges of an IOC in this article (⬃$700), the actual cost is closer to ⬃$300 to $350, falling well within the range of cost-effectiveness demonstrated in our study. The often quoted $100,000 to $300,000 estimate for cost of CBDI repair might be an underestimate of the true, current cost, for several reasons. First, these estimates are derived from studies more than a decade old. Second, ⬎90% of CBDI repairs performed at nonreferral centers will require an operative revision or additional nonoperative interventions,3,4 all of which will be additive to the total financial burden on the health care system as a whole. There has also been a proliferation of nonoperative, interventional approaches to CBDI with repeated stenting, dilation, and radiologic studies, all of which add to the cost of CBDI management. No recent study has evaluated total cost attributable to subsequent procedures and readmissions for complications arising from repair of a CBDI. All appropriately sized studies evaluating this issue support routine IOC.5 High-risk industries, such as aviation and nuclear power, became safer over time by consistently applying interventions that prevent even rare, catastrophic outcomes. IOC is a simple and relatively inexpensive intervention that can sometimes prevent severe CBDI. Following the example of other high-risk industries, the surgical community should create a safety culture where even rare events like CBDI are accounted for by better training and standard use of safety measures such as IOC.
REFERENCES 1. Livingston EH, Miller JA, Coan B, Rege RV. Costs and utilization of intraoperative cholangiography. J Gastrointest Surg 2007;11: 1162–1167. 2. Flum DR, Flowers C, Veenstra DL. A cost-effectiveness analysis of intraoperative cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy. J Am Coll Surg 2003;196:385–393. 3. Lillemoe KD, Martin SA, Cameron JL, et al. Major bile duct injuries during laparoscopic cholecystectomy. Follow-up after combined surgical and radiologic management. Ann Surg 1997; 225:459–471. 4. Woods MS, Traverso LW, Kozarek RA, et al. Characteristics of biliary tract complications during laparoscopic cholecystectomy: a multi-institutional study. Am J Surg 1994;167:27–34. 5. Massarweh NN, Flum DR. Role of intraoperative cholangiography in avoiding bile duct injury. J Am Coll Surg 2007;204: 656–664.
J Am Coll Surg
Colonic Anastomotic Leak: Risk Factors, Diagnosis, and Treatment Giuseppe Brisinda, MD, Serafino Vanella, MD, Federica Cadeddu, MD, Pasquale Mazzeo, MD Rome, Italy We read with interest the very excellent collective review by Kingham and Pachter.1 The authors have clearly identified risk factors contributing to intestinal anastomotic breakdown and delineate methods of diagnosis and treatment of this universally dreaded complication. Remarkable progress has been made in the treatment of rectal cancer. The main goal of rectal operations for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual and urinary function.1-6 Sphincter-saving procedures associated with partial or total mesorectal excision for the treatment of mid and distal rectal cancer have become increasingly prevalent because their safety and efficacy have been proved.3-5 Introduction of circular stapling devices is largely responsible for their increasing popularity and use. According to the authors, we believe that the incidence of anastomotic leak varies widely, depending on the anastomosis type and distance from the anal verge.1,6 In a recent study,6 early and late postoperative complications in 77 T1-T2 rectal cancer patients who underwent rectal resection with stapled end to end anastomosis or end to side anastomosis have been evaluated. Postoperative outcomes of the two procedures, clinicopathological features between patients with and without anastomotic leakage, have been compared. In 37 patients, an end to end anastomosis was performed and in 40 patients an end to side anastomosis was done. The overall incidence of anastomotic leakage was 16.8% (13 of 77 patients). Anastomotic leakage after end to end anastomosis was 29.2%, and after end to side anastomosis was 5% (p ⫽ 0.005). In the end to end group, 11 patients had anastomotic leaks: 9 patients needed a reintervention with colostomy creation; 2 patients were treated with local washouts and IV antibiotics. Two patients from the end to side group experienced anastomotic leakage and were successfully treated with local washouts and antibiotics for 6 weeks. Incomplete bowel preparation and blood transfusions were significantly related to the development of the anastomotic leakage. On the basis of the distal section of the rectum, we divided anastomosis in two groups: medium rectum anastomosis and low rectum anastomosis. Thirty-eight medium rectum anastomosis (18 end to end and 20 end to side) and 39 low rectum anastomosis (19 end to end and 20 end to side) were performed. Anastomotic level was significantly related (p ⫽ 0.001) to the leakage rate. Patients who
Vol. 208, No. 6, June 2009
underwent total mesorectal excision had a significantly higher leakage rate than patients who underwent partial mesorectal excision (30.7% versus 2.6%; p ⫽ 0.001). In this prospective study, outcomes were compared between end to end and end to side anastomosis in anterior resection with mesorectal excision for T1-T2 rectal cancer. The patients studied currently were those with a potentially resectable tumor without signs of spread and where restorative operation was deemed possible to perform. Patients were randomized at a late stage of operation. After a total mesorectal excision had been performed, and if there were no macroscopical signs of local residual disease, both methods had to be deemed possible to perform before randomization took place. The technique used to fashion a colorectal anastomosis is based largely on surgeon preference. To achieve an adequate anastomosis with a low rate of postoperative leak, certain basic surgical principles must be met.
REFERENCES 1. Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg 2009;208:269–278. 2. Rullier E, Laurent C, Bretagnol F, et al. Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg 2005;241:465–469. 3. Murphy J, Hammond TM, Knowles CH, et al. Does anastomotic technique influence anorectal function after sphincter-saving rectal cancer resection? A systematic review of evidence from randomized trials. J Am Coll Surg 2007;204:673–680. 4. Yeh CY, Changchien CR, Wang JY, et al. Pelvic drainage and other risk factors for leakage after elective anterior resection in rectal cancer patients: a prospective study of 978 patients. Ann Surg 2005;241:9–13. 5. den Dulk M, Smit M, Peeters KC, et al. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol 2007;8:297–303. 6. Brisinda G, Vanella S, Cadeddu F, et al. End-to-end versus endto-side stapled anastomosed after anterior resection for rectal cancer. J Surg Oncol 2009;99:75–79.
Reply T Peter Kingham, MD, H Leon Pachter, MD, FACS New York, NY We appreciate the commentary by Brisinda in reference to our review “Colonic Anastomotic Leak: Risk Factors, Diagnosis, and Treatment.”1 Their study, in which 77 patients with T1 or T2 rectal cancers were randomized to end to end anastomoses or end to side anastomoses provides some in-
Letters 1153
teresting data about stapling technique.2 Leak rates were significantly lower for end to side anastomoses (5%) compared with end to end anastomoses (29.2%; p ⫽ 0.005). In addition, there was a higher leak rate in low rectal anastomoses (31%), defined as ⬍8 cm from the anal verge, compared with mid-rectal anastomoses (3%; p ⫽ 0.001). Another important finding was the difference in reoperations, with 24% of the end to end anastomoses group requiring reoperation, compared with 0% of the end to side group (p ⫽ 0.0008). One of the striking results in Brisinda’s study is the large difference in leak rate between patients who underwent total mesorectal excision (TME; 30.7%) compared with partial mesorectal excision (2.6%; p ⫽ 0.001). Although TME is thought to have a higher complication rate, there is generally not as large a disparity as is seen in this study.3 Because of the improved clearance of lymphovascular tissue surrounding the rectum and decreased local recurrence rates, we advocate TME for low rectal cancers. As described in our review, proximal diversion does not prevent anastomotic leaks. Diversion does decrease the clinical sequelae of a leak.4 In the study presented by Brisinda and colleagues, no diverting ostomies were used, even in low anastomoses. Had they been used, they might have decreased the considerable reoperative rate in the group of patients with an anastomotic leak. Technical considerations that are of paramount importance in low rectal anastomoses include tension-free proximal and distal stumps with adequate blood supply. The technique we favor for low rectal anastomoses is an end to end circular stapled anastomosis, with a purse string only on the proximal colonic limb. It is not surprising that there was a considerably higher leak rate in the group labeled end to end in Brisinda’s study, where a purse string was applied to the rectal stump, because this can be technically challenging to perform in low rectal patients and in male patients. More specifically, we believe the rectum is at times too big and the purse string never really brings the bowel wall onto the shaft of the end-to-end anastomotic stapler, leaving small gaps that are high-risk areas for leaks. Because of this technique, the study by Brisinda and colleagues does not definitively answer the question about whether end to side anastomoses have fewer complications than end to end anastomoses. It is much preferred to perform end to end anastomoses without using a distal purse string, and we use this as our standard rectal anastomosis. We instead submit that the appropriate conclusion from their trial is that low rectal anastomoses should not incorporate a rectal stump purse string, unless an ana-