Early versus late reversal of loop ileostomy after rectal resection for cancer (EASY)

 

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.

Hypothesis

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.

Endpoints

Primary:

Recording and comparison of the frequency of post-operative complications 0 – 12 months postoperatively

Secondary:

-       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.

Inclusion/exclusion

Inclusion criteria:

-       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

Exclusion criteria

-       Patients on steroids

-       Patients with diabetes

-       Patients with speech problems

-       Patients with anticipated poor compliance, e.g. psychiatric reasons

Inclusion:

By November 2014, 112 patients had been randomized, and inclusion was stopped.

Participating hospitals

Sweden: Norra Älvsborgs Länssjukhus, Kärnsjukhuset i Skövde, Sahlgrenska Universitetssjukhuset,

Denmark: Herlev Hospital, Nordsjællands Hospital - Hillerød, Roskilde Hospital, Svendborg Sygehus.

Documents

Study protocol (click name to download): EASY

Publication(s):

Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Correa Marinez A,
Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients
With Rectal Cancer. A Multicenter Randomized Controlled Trial. ANNSURG-D-16-00345

Danielsen Kjaergaard A, Correra-Marinez A, Angenete E, Skullman S, Haglind E,  Rosenberg J. Early closure of temporary ileostomy - the EASY trial: protocol for a randomized controlled trial. BMJ Open. 2011 1(1):e000162.

Contact

Principal investigator:

Jacob Rosenberg

Deputy principal investigator:

Eva Haglind

Contact:

Post-doc Eva Angenete (eva.angenete@vgregion.se), Deputy PI Eva Haglind, (eva.haglind@vgregion.se) or research nurse Anette Wedin (anette.wedin@vgregion.se)