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.
- Recording and comparison of the frequency of post-operative complications 0 – 12 months postoperatively.
- Recording and comparison of the total costs for the control and intervention groups respectively 0-12 months post-operatively.
- Analysis and comparison of health related quality of life as measured with SF36 3, 6 and 12
months after stoma construction.
- Analysis and description of quality of life specific to the illness measured with EORTC
QLQ-CR29 three, six and twelve months after stoma construction if stoma not closed.
- Analysis and description of quality of life specific to the illness in the control group
measured with Ostomy Adjustment Scale 3, 6 and12 months after stoma construction if stoma not closed.
- Adult patients (18+) who have been operated for rectal cancer (low anterior resection of the rectum) with construction of protective temporary ileostomy.
- No sign of active infection or organ failure.
- No anastomosis leakage (ensured by CT scanning).
- Functioning stoma.
- Documented post-operative recovery (including CRP, red blood cells, nutrition, mobilisation, stoma function).
- Written consent.
- Patients on steroids.
- Patients with diabetes.
- Patients with speech problems.
- Patients with anticipated poor compliance, e.g. psychiatric reasons.
Inclusion of patients:
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.
Protocol (click on name to view/download): EASY
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.
Deputy principal investigator:
Post-doc Eva Angenete (firstname.lastname@example.org), Deputy PI Eva Haglind, (email@example.com) or research nurse Anette Wedin (firstname.lastname@example.org)