Clinical trial NCT01287637: Early Closure of Temporary Ileostomy
Official title: Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
Temporary ileostomy
Ealy reversal
Morbidity
Mortality
Quality of life
Economic effect
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).

Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.

The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.

The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.

Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.

An interim analysis is planned for safety as well as recalculation of statistical power.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients whose stoma is not reversible
* Patients with diabetes
* Patients being treated with Steroids
* Patients with communicative problems
* Patients with expected compliance issues

Primary outcomes:
measure: Postsurgical morbidity
timeFrame: 3 months after inclusion
measure: Postsurgical morbidity
timeFrame: 6 months after inclusion
measure: Postsurgical morbidity.
timeFrame: 12 months after inclusion-
Secondary outcomes:
measure: Quality of life
timeFrame: Quality of life is assessed at 3 months after inclusion
measure: Quality of life
timeFrame: Quality of life is assessed at 6 months after inclusion
measure: Quality of life
timeFrame: Quality of life is assessed at 12 months after inclusion
measure: Socio-economic effect of early reversal of temporary ileostomy
timeFrame: The investigators assess and analyze the economic effect 6 months after inclusion
measure: Socio-economic effect of early reversal of temporary ileostomy
timeFrame: The investigators assess and analyze the economic effect 12 months after inclusion
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital, University of Copenhagen
Study officials:
affiliation: Herlev Hospital, University of Copenhagen
name: Jacob Rosenberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Park 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.
citation: Danielsen 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.
citation: Danielsen 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.