Patterns of Gastrointestinal Recovery after Bowel Resection and Total Abdominal Hysterectomy: Pooled Results from the Placebo Arms of Alvimopan Phase III North American Clinical Trials

Journal of the American College of Surgeons

Volumn 205, Issue 1, 2007, Pages 43-51

  Wolff, Bruce G ^a   Viscusi, Eugene R ^b   Delaney, Conor P ^c   Du, Wei ^d   Techner, Lee ^d  

^a MAYO CLINIC   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c CASE WESTERN RESERVE UNIVERSITY   (United States)

^d ADOLOR CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALVIMOPAN; OPIATE; PLACEBO;

ABDOMINAL HYSTERECTOMY; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEEDING; GASTROINTESTINAL MOTILITY; GASTROINTESTINAL TRACT FUNCTION; HOSPITAL DISCHARGE; HUMAN; ILEUS; INTESTINE RESECTION; LAPAROTOMY; META ANALYSIS; NASOGASTRIC TUBE; POSTOPERATIVE CARE; PRIORITY JOURNAL; SYSTEMATIC REVIEW;

ADULT; AGED; CLINICAL TRIALS, PHASE III; FEMALE; GASTROINTESTINAL AGENTS; GASTROINTESTINAL MOTILITY; HUMANS; HYSTERECTOMY; ILEUS; INTESTINES; MALE; MIDDLE AGED; NORTH AMERICA; PIPERIDINES; RECOVERY OF FUNCTION;

EID: 34347357632     PISSN: 10727515     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jamcollsurg.2007.02.026     Document Type: Article

References (41)

1. Delaney C, Kehlet H, Senagore A, et al. Postoperative ileus: profiles, risk factors, and definitions-a framework for optimizing surgical outcomes in patients undergoing major abdominal and colorectal surgery. Available at: http://www.clinicalwebcasts.com/updates/index.htm. Accessed August 2, 2006.
2. Behm B., and Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol 1 (2003) 71-80
3. Kehlet H., and Holte K. Review of postoperative ileus. Am J Surg 182 Suppl (2001) 3S-10S
4. Livingston E.H., and Passaro Jr. E.P. Postoperative ileus. Dig Dis Sci 35 (1990) 121-132
5. Luckey A., Livingston E., and Tache Y. Mechanisms and treatment of postoperative ileus. Arch Surg 138 (2003) 206-214
6. Basse L., Thorbol J.E., Lossl K., and Kehlet H. Colonic surgery with accelerated rehabilitation or conventional care. [published correction in Dis Colon Rectum 2004;47:951]. Dis Colon Rectum 47 (2004) 271-277 discussion 277-278
7. DiFronzo L.A., Yamin N., Patel K., and O'Connell T.X. Benefits of early feeding and early hospital discharge in elderly patients undergoing open colon resection. J Am Coll Surg 197 (2003) 747-752
8. Kariv Y., Wang W., Senagore A.J., et al. Multivariable analysis of factors associated with hospital readmission after intestinal surgery. Am J Surg 191 (2006) 364-371
9. Holte K., and Kehlet H. Postoperative ileus: a preventable event. Br J Surg 87 (2000) 1480-1493
10. Holte K., and Kehlet H. Postoperative ileus: progress towards effective management. Drugs 62 (2002) 2603-2615
11. Kurz A., and Sessler D.I. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs 63 (2003) 649-671
12. Austrup M.L., and Korean G. Analgesic agents for the postoperative period. Opioids Surg Clin North Am 79 (1999) 253-273
13. Schwarz N.T., Kalff J.C., Turler A., et al. Selective jejunal manipulation causes postoperative pan-enteric inflammation and dysmotility. Gastroenterology 126 (2004) 159-169
14. Kalff J.C., Turler A., Schwarz N.T., et al. Intra-abdominal activation of a local inflammatory response within the human muscularis externa during laparotomy. Ann Surg 237 (2003) 301-315
15. Basse L., Raskov H.H., Hjort Jakobsen D., et al. Accelerated postoperative recovery programme after colonic resection improves physical performance, pulmonary function and body composition. Br J Surg 89 (2002) 446-453
16. Correia M.I., and da Silva R.G. The impact of early nutrition on metabolic response and postoperative ileus. Curr Opin Clin Nutr Metab Care 7 (2004) 577-583
17. Delaney C.P., Fazio V.W., Senagore A.J., et al. 'Fast track' postoperative management protocol for patients with high co-morbidity undergoing complex abdominal and pelvic colorectal surgery. Br J Surg 88 (2001) 1533-1538
18. Miedema B.W., and Johnson J.O. Methods for decreasing postoperative gut dysmotility. Lancet Oncol 4 (2003) 365-372
19. Mukherjee A., Senagore A.J., and Delaney C.P. Postoperative care pathways. Semin Colon Rectal Surg 16 (2005) 215-227
20. Delaney C.P. Clinical perspective on postoperative ileus and the effect of opiates. Neurogastroenterol Motil 16 Suppl 2 (2004) 61-66
21. Kehlet H., and Dahl J.B. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet 362 (2003) 1921-1928
22. Raue W., Haase O., Junghans T., et al. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc 18 (2004) 1463-1468
23. Manning B.J., Winter D.C., McGreal G., et al. Nasogastric intubation causes gastroesophageal reflux in patients undergoing elective laparotomy. Surgery 130 (2001) 788-791
24. Nelson R., Tse B., and Edwards S. Systematic review of prophylactic nasogastric decompression after abdominal operations. Br J Surg 92 (2005) 673-680
25. Platell C., and Hall J.C. Atelectasis after abdominal surgery. J Am Coll Surg 185 (1997) 584-592
26. Sagar P.M., Kruegener G., and MacFie J. Nasogastric intubation and elective abdominal surgery. Br J Surg 79 (1992) 1127-1131
27. Hartsell P.A., Frazee R.C., Harrison J.B., and Smith R.W. Early postoperative feeding after elective colorectal surgery. Arch Surg 132 (1997) 518-520 discussion 520-511
28. Reissman P., Teoh T.A., Cohen S.M., et al. Is early oral feeding safe after elective colorectal surgery?. A prospective randomized trial. Ann Surg 222 (1995) 73-77
29. Stewart B.T., Woods R.J., Collopy B.T., et al. Early feeding after elective open colorectal resections: a prospective randomized trial. Aust N Z J Surg 68 (1998) 125-128
30. Basse L., Hjort Jakobsen D., Billesbolle P., et al. A clinical pathway to accelerate recovery after colonic resection. Ann Surg 232 (2000) 51-57
31. nd Annual Clinical Congress of the American College of Surgeons, October 8-12, Chicago, IL. Poster SE120.
32. Delaney C.P., Weese J.L., Hyman N.H., et al. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum 48 (2005) 1114-1125 discussion 1125-1126; author reply 1127-1129
33. Viscusi E.R., Goldstein S., Witkowski T., et al. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc 20 (2006) 64-70
34. Wolff B.G., Michelassi F., Gerkin T.M., et al. 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 (2004) 728-734 discussion 734-735
35. Woods M.S. Postoperative ileus: Dogma versus data from bench to bedside. In: Schrock T.R. (Ed). Perspectives in colon and rectal surgery Vol 12 (2000), Thieme Medical Publishers, Inc, New York 57-76
36. Delaney C.P., Senagore A.J., Viscusi E.R., et al. Postoperative upper and lower gastrointestinal recovery and gastrointestinal morbidity in patients undergoing bowel resection: pooled analysis of placebo data from 3 randomized controlled trials. Am J Surg 191 (2006) 315-319
37. Salvador C.G., Sikirica M., Evans A., et al. Clinical and economic outcomes of prolonged postoperative ileus in patients undergoing hysterectomy and hemicolectomy. P&T 30 (2005) 590-595
38. Akbaba S., Kayaalp C., and Savkilioglu M. Nasogastric decompression after total gastrectomy. Hepatogastroenterology 51 (2004) 1881-1885
39. Sands D.R., and Wexner S.D. Nasogastric tubes and dietary advancement after laparoscopic and open colorectal surgery. Nutrition 15 (1999) 347-350
40. Kehlet H., Buchler M.W., Beart Jr. R.W., et al. Care after colonic operation-is it evidence-based?. Results from a multinational survey in Europe and the United States. J Am Coll Surg 202 (2006) 45-54
41. H-CUPnet: national and regional estimates on hospital use for all patients from the HCUP Nationwide Inpatient Sample. Available at: http://hcup.ahrq.gov/HCUPnet.asp. Accessed July 28, 2006.