Early closure of temporary ileostomydthe EASY trial: Protocol for a randomised controlled trial

BMJ Open

Volumn 1, Issue 1, 2011, Pages

  Danielsen, Anne Kjaergaard ^a   Correa Marinez, Adiela ^b   Angenete, Eva ^b   Skullmann, Stefan ^c   Haglind, Eva ^b   Rosenberg, Jacob ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^c Department of Surgery ^*  (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84860389691     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2011-000162     Document Type: Article

References (47)

1. Chand M, Nash GF, Talbot RW. Timely closure of loop ileostomy following anterior resection for rectal cancer. Eur J Cancer Care (Engl) 2008;17:611-15.
2. Montedori A, Cirocchi R, Farinella E, et al. Covering ileo- or colostomy in anterior resection for rectal carcinoma. Cochrane Database Syst Rev 2010;(5):CD006878.
3. Matthiesen P, Hallböök O, Rutegaard J, et al. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer. Ann Surg 2007;246:207-14. (Pubitemid 47196517)
4. Chow A, Tilney HS, Paraskeva P, et al. The morbidity surrounding reversal of defunctioning ileostomies: a systematic review of 48 studies including 6,107 cases. Int J Colorectal Dis 2009; 24:711-23.
5. Hindenburg T, Rosenberg J. Closing a temporary ileostomy within two weeks. Dan Med Bul 2010;57:1-5.
6. Brown H, Randle J. Living with a stoma: a review of the literature. J Clin Nurs 2005;14:74-81. (Pubitemid 40221632)
7. Gooszen AW, Geelkerken RH, Hermans J, et al. Quality of life with a temporary stoma: ileostomy vs. colostomy. Dis Colon Rectum 2000;43:650-5. (Pubitemid 30324603)
8. Nugent KP, Daniels P, Stewart B, et al. Quality of life in stoma patients. Dis Colon Rectum 1999;42:1569-74. (Pubitemid 30007590)
9. Rauch P, Miny J, Conroy T, et al. Quality of life among disease-free survivors of rectal cancer. J Clin Oncol 2004;22:354-60. (Pubitemid 41095100)
10. Ma N, Harvey J, Stewart J, et al. The effect of age on the quality of life of patients living with stomas: a pilot study. ANZ J Surg 2007;77:883-5. (Pubitemid 47353071)
11. Holzer B, Matzel K, Schiedeck T, et al. Do geographic and educational factors influence the quality of life in rectal cancer patients with a permanent colostomy? Dis Colon Rectum 2005;48:2209-16. (Pubitemid 43074440)
12. Siassi M, Hohenberger W, Lösel F, et al. Quality of life and patient's expectations after closure of a temporary stoma. Int J Colorectal Dis 2008;23:1207-12.
13. Hamashima C. Long-term quality of life of postoperative rectal cancer patients. J Gastroenterol Hepatol 2002;17:571-6. (Pubitemid 34748179)
14. Engel J, Kerr L. Quality of life in rectal cancer patients. A four-year prospective study. Ann Surg 2010;238:203-13.
15. Sprangers MA, Taal BG, Aaronson NK, et al. Quality of life in colorectal cancer. Stoma vs. nonstoma patients. Dis Colon Rectum 1995;38:361-9.
16. Butler DL. Early postoperative complications following ostomy surgery: a review. J Wound Ostomy Continence Nurs 2009;36:513-19.
17. Cottam J, Richards K, Hasted A, et al. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery. Colorectal Dis 2007;9:834-8. (Pubitemid 47578032)
18. Shabbir J, Britton DC. Stoma complications: a literature overview. Colorectal Dis 2010;12:958-64.
19. Smith DM, Loewenstein G, Jankovic A, et al. Happily hopeless: adaptation to a permanent, but not to a temporary, disability. Health Psychol 2009;28:787-91.
20. Gronvold M. Health-related quality of life in cancer patients (in Danish). Ugeskr Laeger 2008;170:838-43.
21. Jess P. Quality of life assessments in colorectal surgery (in Danish). Ugeskr Laeger 2008;170:853-5.
22. Burckhardt CS, Hanestad BR. Nursing strategies and quality of life outcomes: a systematic review. Vard i Norden 2003;1:4-9.
23. Wittrup-Jensen KU, Lauridsen J, Pedersen KM. Ønsker danskerne mest mulig sundhed for pengene, når de prioriterer? In: Lauridsen JT, Pedersen KM, eds. Sundhedsøkonomi. Fra Teori til Praksis. Copenhagen, Denmark: Jurist-og Økonomforbundet, 2009:161-74.
24. van den Hout WB, van den Brink M, Stiggelbout AM, et al. Costeffectiveness analysis of colorectal cancer treatments. Eur J Cancer 2002;38:953-63. (Pubitemid 34442323)
25. Horisberger K, Beldi G, Candinas D. Loop ileostomy closure: comparison of cost effectiveness between suture and stapler. World J Surg 2010;34:2867-71.
26. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205-13. (Pubitemid 38963009)
27. Dindo D, Clavien PA. What is a surgical complication? World J Surg 2008;32:939-41.
28. Bue Bjoerner J, Trab DamsgaardM,Watt T, et al. Dansk Manual Til SF-36. Copenhagen, Denmark: Lif, Lægemiddelindustriforeningen, 1997.
29. Taft C, Karlsson J, Sullivan M. Performance of the Swedish SF-36 version 2.0. Qual Life Res 2004;13:251-6. (Pubitemid 38315238)
30. Burckhardt CS. The Ostomy Adjustment Scale: further evidence of reliability and validity. Rehabil Psychol 1990;35:149-55.
31. Olbrisch M. Development and validation of the Ostomy Adjustment Scale. Rehabil Psychol 1983;28:12.
32. Gujral S, Conroy T, Fleissner C, et al. Assessing quality of life in patients with colorectal cancer: an update of the EORTC quality of life questionnaire. Eur J Cancer 2007;43:1564-73. (Pubitemid 46901019)
33. Whistance RN, Conroy T, Chie W, et al. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer 2009;45:3017-26.
34. Goossens ME, Rutten-van Mölken MP, Vlaeyen JW, et al. The cost diary: a method to measure direct and indirect costs in costeffectiveness research. J Clin Epidemiol 2000;53:688-95. (Pubitemid 30609621)
35. van Berge Henegouwen MT, van Driel HF, Kasteleijn-Nolst Trenite DG. A patient diary as a tool to improve medicine compliance. Pharm World Sci 1999;21:21-4. (Pubitemid 29161695)
36. Alves A, Panis Y, Lelong B, et al. Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy. Br J Surg 2008;95:693-8.
37. Bakx R, Busch OR, van GD, et al. Feasibility of early closure of loop ileostomies: a pilot study. Dis Colon Rectum 2003;46:1680-4. (Pubitemid 37532352)
38. Menegaux F, Jordi-Galais P, Turrin N, et al. Closure of small bowel stomas on postoperative day 10. Eur J Surg 2002; 168:713-15. (Pubitemid 36609525)
39. Nagell CF, Pedersen CR, Gyrtrup HJ. [Complications after stoma closure. A retrospective study of 11 years' experience] (in Danish). Ugeskr Laeger 2005;167:1742-5.
40. Dindo D, Hahnloser D, Clavien PA. Quality assessment in surgery: riding a lame horse. Ann Surg 2010;251:766-71.
41. Gronvold M. [Quality of life research methodology]. Ugeskr Laeger 2008;170:825-9.
42. Camilleri-Brennan J, Steele RJ. Objective assessment of morbidity and quality of life after surgery for low rectal cancer. Colorectal Dis 2002;4:61-6. (Pubitemid 34285259)
43. Neumann HB, Patil S, Fuzesi S, et al. Impact of a temporary stoma on the quality of life of rectal cancer patients undergoing treatment. Ann Surg Oncol 2011;18:1397-403.
44. O'Leary DP, Fide CJ, Foy C, et al. Quality of life efter low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg 2001;88:1220.
45. Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann Med 2001;33:344-9. (Pubitemid 32675375)
46. Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the Economic Evaluation of Health Care Programmes. 3rd edn. Oxford: Oxford University Press, 2005.
47. Kronborg C, Vass M, Lauridsen J, et al. Cost effectiveness of preventive home visits to the elderly. Economic evaluation alongside randomized controlled study. Eur J Health Econ 2006;7:238-46.