Early Closure of Temporary Ileostomy
NCT01287637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89
Last updated 2016-01-20
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.
Conditions
Interventions
- PROCEDURE
-
Early reversal of temporary ileostomy
Temporary ileostomy is reversed 8-13 days after the primary surgery
- PROCEDURE
-
Standard reversal of temporary ileostomy
Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation
Sponsors & Collaborators
-
Herlev Hospital
lead OTHER
Principal Investigators
-
Jacob Rosenberg, Professor · Herlev Hospital, University of Copenhagen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2015-11-30
- Completion
- 2015-12-31
Countries
- Denmark
Study Locations
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