LETTERs TO THE EDITOR
Preoperative Exposure to Biologics and Surgeons’ Attitude Toward the Surgical Approach in Ulcerative Colitis To the Editor—We read with interest the paper by Bikhchandani et al,1 who retrospectively examined data collected by the ACS-NSQIP between 2002 and 2011 and reported on the trends in the U.S. regarding 3-stage versus 2-stage ileal pouch-anal anastomosis (IPAA). The paper is interesting and its limitations are honestly disclosed. The authors reported that the frequency of the 3-stage approach declined between 2002 and 2006 and then remained stable thereafter. An additional strength of this study is that staged approaches are also the most frequently used in Europe, with 1-stage IPAA accounting for 20 mg prednisone or lower) for steroids at surgery is essential.4,8–10 We thank Bikhchandani et al for presenting these real-life data, but we believe that a more detailed analysis of many factors is required – among which is the central role biologics are likely to play in upcoming years – before drawing any conclusions concerning the advantages or disadvantages of one approach over another. REFERENCES 1. Bikhchandani J, Polites SF, Wagie AE, Habermann EB, Cima RR. National trends of 3- versus 2-stage restorative proctocolectomy for chronic ulcerative colitis. Dis Colon Rectum. 2015;58:199–204. 2. Pellino G, Sciaudone G, Canonico S, Selvaggi F. Role of ileostomy in restorative proctocolectomy. World J Gastroenterol. 2012;18:1703–1707. 3. Øresland T, Bemelman WA, Sampietro GM, et al.; European Crohn’s and Colitis Organisation (ECCO). European evidence based consensus on surgery for ulcerative colitis. J Crohns Colitis. 2015;9:4–25. 4. Selvaggi F, Sciaudone G, Limongelli P, et al. The effect of pelvic septic complications on function and quality of life after ileal pouch-anal anastomosis: a single center experience. Am Surg. 2010;76:428–435. 5. Tekkis PP, Heriot AG, Smith JJ, Das P, Canero A, Nicholls RJ. Long-term results of abdominal salvage surgery following restorative proctocolectomy. Br J Surg. 2006;93:231–237. 6. Gu J, Remzi FH, Shen B, Vogel JD, Kiran RP. Operative strategy modifies risk of pouch-related outcomes in patients with ulcerative colitis on preoperative anti-tumor necrosis factor-α therapy. Dis Colon Rectum. 2013;56:1243–1252. 7. Selvaggi F, Pellino G, Canonico S, Sciaudone G. Effect of preoperative biologic drugs on complications and function after restorative proctocolectomy with primary ileal pouch formation: systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:79–92. 8. Nicholls RJ, Holt SD, Lubowski DZ. Restorative proctocolectomy with ileal reservoir. Comparison of two-stage vs. threestage procedures and analysis of factors that might affect outcome. Dis Colon Rectum. 1989;32:323–326. 9. Lake JP, Firoozmand E, Kang JC, et al. Effect of high-dose steroids on anastomotic complications after proctocolectomy with ileal pouch-anal anastomosis. J Gastrointest Surg. 2004;8:547–551. 10. Lim M, Sagar P, Abdulgader A, Thekkinkattil D, Burke D. The impact of preoperative immunomodulation on pouch-related
e413
Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited.
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LEtters to the Editor
septic complications after ileal pouch-anal anastomosis. Dis Colon Rectum. 2007;50:943–951.
Gianluca Pellino, M.D. Francesco Selvaggi, M.D., E.B.S.Q. colo Naples, Italy
The Authors Reply To the Editor—The best surgical approach to IPAA in chronic ulcerative colitis has been long debated. In major tertiary centers, the pendulum seems to have shifted toward a 3-stage approach.1,2 Our study was designed based on a large nationwide database to understand the changes in practice patterns over time in North America and evaluate the outcomes of the 3-stage versus the 2-stage approach.3 As Pellino and colleagues correctly point out, the decision on which surgical approach is offered is based on a number of critical patient factors, including the duration of disease and the previous management strategies used. These include the types of medical therapy administered. Our results and interpretations of these findings need to be viewed in the light of the inherent limitations of the American College of Surgeons National Surgical Quality Improvement Program data set.4 Important IBD specific information; the preoperative use of biologic therapy, steroid dosing, and duration of use; and the anastomotic leak rate, as well as other data points, are not collected. Additionally, the aggregate data are all deidentified, making even hospitallevel comparisons difficult. We agree with our colleagues that these are critical questions to be answered to determine the best course of action. However, this was not the intent of our report. In the recent years, biologics have become the mainstay for the medical treatment of chronic ulcerative colitis. The impact of preoperative biologics on surgical outcomes of IPAA remains controversial, however. A single-institution case series retrospectively looked at the rates of pelvic sepsis 1 year after IPAA and found that the use of antitumor necrosis factor preoperatively was an independent predictor for postoperative pelvic sepsis (OR, 2.62; p < 0.05).2 A recently published meta-analysis, however, showed that the use of infliximab showed a trend toward higher total and infectious complications, but no statistically significant difference was observed.5 It is clear that the jury is still out on the issue. We agree with the authors of the letter that the use of biologics is a key factor that may play a role in proving the superiority of 1 approach over another. As previously mentioned, the American College of Surgeons National Surgical Quality Improvement Program data set does not include this information. This may explain why in our study, even though by objective
criteria the patients who undergo a 3-stage surgery were healthier at the time of IPAA, nonetheless, there was no statistically significant difference in the complication rate in the 2 approaches.3 The authors have also rightly pointed out the lack of information on the dose of steroids used preoperatively in our study.3 Again, this is clearly vital but unavailable from the data set we used. This may explain the findings that, in a multivariate regression model, the use of preoperative steroids did not influence the risk of developing 30-day postoperative infectious complications. Ileal pouch-anal anastomosis has become the standard for surgical treatment of medically refractory chronic ulcerative colitis. The future goal should be to fine tune the timing of surgery to maximize success and minimize complications, specifically infectious complications related to anastomotic leak, because they impact long-term pouch function. A prospective randomized study may provide a lot of answers but will need a multicenter multi-institution trial with a large number of patients that might require years of recruiting. Furthermore, as the pace of change in the number and types of biologic agents available to treat ulcerative colitis increases, such a study would become very difficult to interpret. In the meantime, the data available to us do support the use of a 3-stage approach to IPAA, the downside being an additional surgery with its cost and economic implications that we did not attempt to quantify. We thank the authors for all their comments and interest in our work. REFERENCES 1. Pandey S, Luther G, Umanskiy K, et al. Minimally invasive pouch surgery for ulcerative colitis: is there a benefit in staging? Dis Colon Rectum. 2011;54:306–310. 2. Gu J, Remzi FH, Shen B, Vogel JD, Kiran RP. Operative strategy modifies risk of pouch-related outcomes in patients with ulcerative colitis on preoperative anti-tumor necrosis factor-α therapy. Dis Colon Rectum. 2013;56:1243–1252. 3. Bikhchandani J, Polites SF, Wagie AE, Habermann EB, Cima RR. National trends of 3- versus 2-stage restorative proctocolectomy for chronic ulcerative colitis. Dis Colon Rectum. 2015;58:199–204. 4. American College of Surgeons. Participant use file. http:// site. acsnsqip.org/participant-use-data-file/. Accessed April 14, 2014. 5. Selvaggi F, Pellino G, Canonico S, Sciaudone G. Effect of preoperative biologic drugs on complications and function after restorative proctocolectomy with primary ileal pouch formation: systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:79–92.
Jai Bikhchandani, M.D. Robert R. Cima, M.D. Rochester, MN
Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited.
Preoperative Exposure to Biologics and Surgeons’ Attitude Toward the Surgical Approach in Ulcerative Colitis To the Editor—We read with interest the paper by Bikhchandani et al,1 who retrospectively examined data collected by the ACS-NSQIP between 2002 and 2011 and reported on the trends in the U.S. regarding 3-stage versus 2-stage ileal pouch-anal anastomosis (IPAA). The paper is interesting and its limitations are honestly disclosed. The authors reported that the frequency of the 3-stage approach declined between 2002 and 2006 and then remained stable thereafter. An additional strength of this study is that staged approaches are also the most frequently used in Europe, with 1-stage IPAA accounting for 20 mg prednisone or lower) for steroids at surgery is essential.4,8–10 We thank Bikhchandani et al for presenting these real-life data, but we believe that a more detailed analysis of many factors is required – among which is the central role biologics are likely to play in upcoming years – before drawing any conclusions concerning the advantages or disadvantages of one approach over another. REFERENCES 1. Bikhchandani J, Polites SF, Wagie AE, Habermann EB, Cima RR. National trends of 3- versus 2-stage restorative proctocolectomy for chronic ulcerative colitis. Dis Colon Rectum. 2015;58:199–204. 2. Pellino G, Sciaudone G, Canonico S, Selvaggi F. Role of ileostomy in restorative proctocolectomy. World J Gastroenterol. 2012;18:1703–1707. 3. Øresland T, Bemelman WA, Sampietro GM, et al.; European Crohn’s and Colitis Organisation (ECCO). European evidence based consensus on surgery for ulcerative colitis. J Crohns Colitis. 2015;9:4–25. 4. Selvaggi F, Sciaudone G, Limongelli P, et al. The effect of pelvic septic complications on function and quality of life after ileal pouch-anal anastomosis: a single center experience. Am Surg. 2010;76:428–435. 5. Tekkis PP, Heriot AG, Smith JJ, Das P, Canero A, Nicholls RJ. Long-term results of abdominal salvage surgery following restorative proctocolectomy. Br J Surg. 2006;93:231–237. 6. Gu J, Remzi FH, Shen B, Vogel JD, Kiran RP. Operative strategy modifies risk of pouch-related outcomes in patients with ulcerative colitis on preoperative anti-tumor necrosis factor-α therapy. Dis Colon Rectum. 2013;56:1243–1252. 7. Selvaggi F, Pellino G, Canonico S, Sciaudone G. Effect of preoperative biologic drugs on complications and function after restorative proctocolectomy with primary ileal pouch formation: systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:79–92. 8. Nicholls RJ, Holt SD, Lubowski DZ. Restorative proctocolectomy with ileal reservoir. Comparison of two-stage vs. threestage procedures and analysis of factors that might affect outcome. Dis Colon Rectum. 1989;32:323–326. 9. Lake JP, Firoozmand E, Kang JC, et al. Effect of high-dose steroids on anastomotic complications after proctocolectomy with ileal pouch-anal anastomosis. J Gastrointest Surg. 2004;8:547–551. 10. Lim M, Sagar P, Abdulgader A, Thekkinkattil D, Burke D. The impact of preoperative immunomodulation on pouch-related
e413
Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited.
e414
LEtters to the Editor
septic complications after ileal pouch-anal anastomosis. Dis Colon Rectum. 2007;50:943–951.
Gianluca Pellino, M.D. Francesco Selvaggi, M.D., E.B.S.Q. colo Naples, Italy
The Authors Reply To the Editor—The best surgical approach to IPAA in chronic ulcerative colitis has been long debated. In major tertiary centers, the pendulum seems to have shifted toward a 3-stage approach.1,2 Our study was designed based on a large nationwide database to understand the changes in practice patterns over time in North America and evaluate the outcomes of the 3-stage versus the 2-stage approach.3 As Pellino and colleagues correctly point out, the decision on which surgical approach is offered is based on a number of critical patient factors, including the duration of disease and the previous management strategies used. These include the types of medical therapy administered. Our results and interpretations of these findings need to be viewed in the light of the inherent limitations of the American College of Surgeons National Surgical Quality Improvement Program data set.4 Important IBD specific information; the preoperative use of biologic therapy, steroid dosing, and duration of use; and the anastomotic leak rate, as well as other data points, are not collected. Additionally, the aggregate data are all deidentified, making even hospitallevel comparisons difficult. We agree with our colleagues that these are critical questions to be answered to determine the best course of action. However, this was not the intent of our report. In the recent years, biologics have become the mainstay for the medical treatment of chronic ulcerative colitis. The impact of preoperative biologics on surgical outcomes of IPAA remains controversial, however. A single-institution case series retrospectively looked at the rates of pelvic sepsis 1 year after IPAA and found that the use of antitumor necrosis factor preoperatively was an independent predictor for postoperative pelvic sepsis (OR, 2.62; p < 0.05).2 A recently published meta-analysis, however, showed that the use of infliximab showed a trend toward higher total and infectious complications, but no statistically significant difference was observed.5 It is clear that the jury is still out on the issue. We agree with the authors of the letter that the use of biologics is a key factor that may play a role in proving the superiority of 1 approach over another. As previously mentioned, the American College of Surgeons National Surgical Quality Improvement Program data set does not include this information. This may explain why in our study, even though by objective
criteria the patients who undergo a 3-stage surgery were healthier at the time of IPAA, nonetheless, there was no statistically significant difference in the complication rate in the 2 approaches.3 The authors have also rightly pointed out the lack of information on the dose of steroids used preoperatively in our study.3 Again, this is clearly vital but unavailable from the data set we used. This may explain the findings that, in a multivariate regression model, the use of preoperative steroids did not influence the risk of developing 30-day postoperative infectious complications. Ileal pouch-anal anastomosis has become the standard for surgical treatment of medically refractory chronic ulcerative colitis. The future goal should be to fine tune the timing of surgery to maximize success and minimize complications, specifically infectious complications related to anastomotic leak, because they impact long-term pouch function. A prospective randomized study may provide a lot of answers but will need a multicenter multi-institution trial with a large number of patients that might require years of recruiting. Furthermore, as the pace of change in the number and types of biologic agents available to treat ulcerative colitis increases, such a study would become very difficult to interpret. In the meantime, the data available to us do support the use of a 3-stage approach to IPAA, the downside being an additional surgery with its cost and economic implications that we did not attempt to quantify. We thank the authors for all their comments and interest in our work. REFERENCES 1. Pandey S, Luther G, Umanskiy K, et al. Minimally invasive pouch surgery for ulcerative colitis: is there a benefit in staging? Dis Colon Rectum. 2011;54:306–310. 2. Gu J, Remzi FH, Shen B, Vogel JD, Kiran RP. Operative strategy modifies risk of pouch-related outcomes in patients with ulcerative colitis on preoperative anti-tumor necrosis factor-α therapy. Dis Colon Rectum. 2013;56:1243–1252. 3. Bikhchandani J, Polites SF, Wagie AE, Habermann EB, Cima RR. National trends of 3- versus 2-stage restorative proctocolectomy for chronic ulcerative colitis. Dis Colon Rectum. 2015;58:199–204. 4. American College of Surgeons. Participant use file. http:// site. acsnsqip.org/participant-use-data-file/. Accessed April 14, 2014. 5. Selvaggi F, Pellino G, Canonico S, Sciaudone G. Effect of preoperative biologic drugs on complications and function after restorative proctocolectomy with primary ileal pouch formation: systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:79–92.
Jai Bikhchandani, M.D. Robert R. Cima, M.D. Rochester, MN
Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited.
