Early Closure of Temporary Ileostomy
EASY
1 other identifier
interventional
89
1 country
1
Brief Summary
The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net). The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 20, 2016
January 1, 2016
4.8 years
January 28, 2011
January 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Postsurgical morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
3 months after inclusion
Postsurgical morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
6 months after inclusion
Postsurgical morbidity.
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
12 months after inclusion-
Secondary Outcomes (5)
Quality of life
Quality of life is assessed at 3 months after inclusion
Quality of life
Quality of life is assessed at 6 months after inclusion
Quality of life
Quality of life is assessed at 12 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
The investigators assess and analyze the economic effect 6 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
The investigators assess and analyze the economic effect 12 months after inclusion
Study Arms (2)
Early reversal group
EXPERIMENTALEarly reversal of temporary ileostomy
Control group
ACTIVE COMPARATORStandard reversal of temporary ileostomy
Interventions
Temporary ileostomy is reversed 8-13 days after the primary surgery
Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation
Eligibility Criteria
You may qualify if:
- Patients with a temporary ileostomy after low anterior resection because of rectal cancer
- Patients, who are physically and mentally fit to undergo surgery within 8-13 days
You may not qualify if:
- Patients whose stoma is not reversible
- Patients with diabetes
- Patients being treated with Steroids
- Patients with communicative problems
- Patients with expected compliance issues
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Herlev Hospital, University of Copenhagen
Herlev, 2730, Denmark
Related Publications (4)
Park J, Angenete E, Bock D, Correa-Marinez A, Danielsen AK, Gehrman J, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial). Surg Endosc. 2020 Jan;34(1):69-76. doi: 10.1007/s00464-019-06732-y. Epub 2019 Mar 25.
PMID: 30911920DERIVEDPark J, Danielsen AK, Angenete E, Bock D, Marinez AC, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial). Br J Surg. 2018 Feb;105(3):244-251. doi: 10.1002/bjs.10680. Epub 2017 Nov 23.
PMID: 29168881DERIVEDDanielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017 Feb;265(2):284-290. doi: 10.1097/SLA.0000000000001829.
PMID: 27322187DERIVEDDanielsen AK, Correa-Marinez A, Angenete E, Skullmann S, Haglind E, Rosenberg J; SSORG (Scandinavian Outcomes Research Group). Early closure of temporary ileostomy--the EASY trial: protocol for a randomised controlled trial. BMJ Open. 2011 Jul 29;1(1):e000162. doi: 10.1136/bmjopen-2011-000162.
PMID: 22021780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Rosenberg, Professor
Herlev Hospital, University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Nurse
Study Record Dates
First Submitted
January 28, 2011
First Posted
February 1, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
January 20, 2016
Record last verified: 2016-01