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Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use?

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Abstract

Background

Postoperative ileus (POI) is a major cause of morbidity, increased length of stay (LOS) and hospital cost after colorectal surgery. Alvimopan is a µ-opioid antagonist used to accelerate upper and lower gastrointestinal function after bowel resection. We hypothesized that alvimopan would reduce LOS in patients undergoing colorectal resection with stoma, a situation that has not been evaluated.

Methods

A retrospective review (2010–2015) identified 58 patients who underwent colorectal resection for benign or malignant disease with stoma creation and received alvimopan. They were case-matched to 58 non-alvimopan patients based on age, BMI, baseline comorbidities, stoma type created and surgical approach. We compared overall LOS, incidence of POI and other postoperative complications.

Results

There were equal numbers of laparoscopic (N = 18) and open resections (N = 40) in the alvimopan group and non-alvimopan group. There were also equal numbers of patients with an ileostomy (N = 37) or colostomy (N = 21) in each group. Overall, 41 patients underwent resection for malignant disease in the alvimopan group compared to 37 in the non-alvimopan group. There was a significant reduction in median LOS overall (alvimopan 5 (4–7) versus control 6 (4.75–9.25) days, P = 0.03). While the 6-day median LOS was similar for patients undergoing ileostomy creation (P = 0.25), alvimopan patients had a 3-day decreased median LOS that approached statistical significance (P = 0.06). The overall 30-day complication rate was higher in the control group (41.4 vs. 51.7%, P = 0.26), but the readmission rate within 30 days was higher in the alvimopan group (19 vs. 13.8%, P = 0.45). Neither of these differences reached statistically significance.

Conclusion

The use of alvimopan in patients undergoing colorectal resection with stoma is associated with a significantly shorter LOS, but the increased readmission rate warrants further study. Based on these data, alvimopan should be evaluated in a controlled setting for patients undergoing colorectal resection with colostomy creation.

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References

  1. Behm B, Stollman N (2003) Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol 1:71–80. doi:10.1053/cgh.2003.50012

    Article  PubMed  Google Scholar 

  2. Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA, Alvimopan Postoperative Ileus Study G (2005) Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum 48:1114–1119. doi:10.1007/s10350-005-0035-7

    Article  PubMed  Google Scholar 

  3. Absher RK, Gerkin TM, Banares LW (2010) Alvimopan use in laparoscopic and open bowel resections: clinical results in a large community hospital system. Ann Pharmacother 44:1701–1708. doi:10.1345/aph.1P260

    Article  CAS  PubMed  Google Scholar 

  4. Kelley SR, Wolff BG, Lovely JK, Larson DW (2013) Fast-track pathway for minimally invasive colorectal surgery with and without alvimopan (Entereg): which is more cost-effective? Am Surg 79:630–633

    PubMed  Google Scholar 

  5. Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA, Alvimopan Postoperative Ileus Study G (2004) Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg 240:725–728

    Google Scholar 

  6. Merck (2015) ENTEREG [package insert]. pp 1–15

  7. Delaney CP, Fazio VW, Senagore AJ, Robinson B, Halverson AL, Remzi FH (2001) “Fast track” postoperative management protocol for patients with high co-morbidity undergoing complex abdominal and pelvic colorectal surgery. Br J Surg 88:1533–1538. doi:10.1046/j.0007-1323.2001.01905.x

    Article  CAS  PubMed  Google Scholar 

  8. Senagore AJ, Delaney CP (2006) A critical analysis of laparoscopic colectomy at a single institution: lessons learned after 1000 cases. Am J Surg 191:377–380

    Article  PubMed  Google Scholar 

  9. Delaney CP (2008) Outcome of discharge within 24 to 72 hours after laparoscopic colorectal surgery. Dis Colon Rectum 51:181–185. doi:10.1007/s10350-007-9126-y

    Article  PubMed  Google Scholar 

  10. Dindo D, Demartines N, Clavien P-A (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213. doi:10.1097/01.sla.0000133083.54934.ae

    Article  PubMed  PubMed Central  Google Scholar 

  11. Ehlers AP, Simianu VV, Bastawrous AL, Billingham RP, Davidson GH, Fichera A, Florence MG, Menon R, Thirlby RC, Flum DR, Farjah F (2016) Alvimopan use, outcomes, and costs: a report from the surgical care and outcomes assessment program-comparative effectiveness research translation network collaborative. J Am Coll Surg. doi:10.1016/j.jamcollsurg.2016.01.051

    Google Scholar 

  12. Ludwig K, Enker WE, Delaney CP et al (2008) Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg 143:1098–1105. doi:10.1001/archsurg.143.11.1098

    Article  CAS  PubMed  Google Scholar 

  13. Ludwig K, Viscusi ER, Wolff BG, Delaney CP, Senagore A, Techner L (2010) Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis. World J Surg 34:2185–2190. doi:10.1007/s00268-010-0635-9

    Article  PubMed  PubMed Central  Google Scholar 

  14. Wolff BG, Weese JL, Ludwig KA, Delaney CP, Stamos MJ, Michelassi F, Du W, Techner L (2007) Postoperative ileus-related morbidity profile in patients treated with alvimopan after bowel resection. J Am Coll Surg 204:609–616. doi:10.1016/j.jamcollsurg.2007.01.041

    Article  PubMed  Google Scholar 

  15. Neary P, Delaney CP (2005) Alvimopan. Expert Opin Investig Drugs 14:479–488. doi:10.1517/13543784.14.4.479

    Article  CAS  PubMed  Google Scholar 

  16. Messaris E, Sehgal R, Deiling S, Koltun WA, Stewart D, McKenna K, Poritz LS (2012) Dehydration is the most common indication for readmission after diverting ileostomy creation. Dis Colon Rectum 55:175–180. doi:10.1097/DCR.0b013e31823d0ec5

    Article  PubMed  Google Scholar 

  17. Paquette IM, Solan P, Rafferty JF, Ferguson MA, Davis BR (2013) Readmission for dehydration or renal failure after ileostomy creation. Dis Colon Rectum 56:974–979. doi:10.1097/DCR.0b013e31828d02ba

    Article  PubMed  Google Scholar 

  18. Hayden DM, Pinzon MCM, Francescatti AB, Edquist SC, Malczewski MR, Jolley JM, Brand MI, Saclarides TJ (2013) Hospital readmission for fluid and electrolyte abnormalities following ileostomy construction: preventable or unpredictable? J Gastrointest Surg 17:298–303. doi:10.1007/s11605-012-2073-5

    Article  PubMed  Google Scholar 

  19. Cartmell MT, Jones OM, Moran BJ, Cecil TD (2008) A defunctioning stoma significantly prolongs the length of stay in laparoscopic colorectal resection. Surg Endosc Other Interv Tech 22:2643–2647. doi:10.1007/s00464-008-9776-4

    Article  Google Scholar 

  20. Ulrich AB, Seiler C, Rahbari N, Weitz J, Büchler MW (2009) Diverting stoma after low anterior resection: more arguments in favor. Dis Colon Rectum 52:412–418. doi:10.1007/DCR.0b013e318197e1b1

    Article  PubMed  Google Scholar 

  21. King PM, Blazeby JM, Ewings P, Franks PJ, Longman RJ, Kendrick AH, Kipling RM, Kennedy RH (2006) Randomized clinical trial comparing laparoscopic and open surgery for colorectal cancer within an enhanced recovery programme. Br J Surg 93:300–308. doi:10.1002/bjs.5216

    Article  CAS  PubMed  Google Scholar 

  22. Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L (2012) Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg 255:731–738. doi:10.1097/SLA.0b013e31824a36cc

    Article  PubMed  Google Scholar 

  23. Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B (2007) Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg 245:355–363. doi:10.1097/01.sla.0000232538.72458.93

    Article  PubMed  PubMed Central  Google Scholar 

  24. Tilney HS, Sains PS, Lovegrove RE, Reese GE, Heriot AG, Tekkis PP (2007) Comparison of outcomes following ileostomy versus colostomy for defunctioning colorectal anastomoses. World J Surg 31:1142–1151. doi:10.1007/s00268-006-0218-y

    Article  PubMed  Google Scholar 

  25. Güenaga KF, Lustosa SAS, Saad SS, Saconato H, Matos D (2007) Ileostomy or colostomy for temporary decompression of colorectal anastomosis. Cochrane Database Syst Rev. doi:10.1002/14651858.CD004647.pub2

    PubMed  Google Scholar 

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Authors’ contribution

Drs. Wen, Brady, Delaney and Steele contributed to conception and design; acquisition of data; analysis and interpretation of data; drafting the article; critical revisions for important intellectual content; and final approval of the version to be published. Drs. Jabir and Champagne, Mr. Keating and Ms. Althans contributed to conception and design; analysis and interpretation of data; critical revisions for important intellectual content; and final approval of the version to be published.

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Correspondence to Justin T. Brady.

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Drs. Yuxiang Wen, Murad A. Jabir, Justin T. Brady, Bradley J. Champagne, Conor P. Delaney, Scott R. Steele, Mr. Keating and Ms. Althans have no conflicts of interest or financial ties to disclose.

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Wen, Y., Jabir, M.A., Keating, M. et al. Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use?. Surg Endosc 31, 3483–3488 (2017). https://doi.org/10.1007/s00464-016-5373-0

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  • DOI: https://doi.org/10.1007/s00464-016-5373-0

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