The study will analyse differences between two different surgical operative regimes in connection with the closure of a protective temporary ileostomy after treatment for rectal cancer. The difference between the two regimes is the interval between constructing the ileostomy (the first operation) and the closure of the stoma (the second operation). The interval until the ileostomy is closed will be 8 – 13 days for the intervention group, and 12 weeks for the control group, which corresponds to normal clinical practice.
Patients who have an ileostomy closed on day 8 – 13 have fewer postoperative complications than patients who have the stoma closed after minimum 12 weeks.
By November 2014, 112 patients had been randomized, and inclusion was stopped.
Sweden: Norra Älvsborgs Länssjukhus, Kärnsjukhuset i Skövde, Sahlgrenska Universitetssjukhuset,
Denmark: Herlev Hospital, Nordsjællands Hospital - Hillerød, Roskilde Hospital, Svendborg Sygehus.
Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).
Park J, Angenete E, Bock D, Correa-Marinez A, Gehrman J, et al.
Surgical endoscopy 2019.
Functional outcomes from a randomized trial of early closure of temporary ileostomy after rectal excision for cancer.
Keane C, Park J, Öberg S, Wedin A, Bock D, et al.
The British journal of surgery 2019;106(5):645-52.
Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial).
Park J, Danielsen A. K., Angenete E, Bock D, Correa-Marinez A, et al.
British Journal of Surgery 2018;105(3):244-51.
Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.
Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, et al.
Annals of Surgery 2017;265(2):284–90.
Early closure of temporary ileostomy--the EASY trial: protocol for a randomised controlled trial.
Danielsen AK, Correa-Marinez A, Angenete E, Skullmann S, Haglind E, Rosenberg J, et al.
BMJ Open 2011;1(1):e000162.