NCT03424447
Unknown
Phase 2
Stimulation of the Efferent Loop Before Loop Ileostomy Closure
Hospital de Basurto1 site in 1 country140 target enrollmentStarted: November 20, 2014Last updated:
Overview
- Phase
- Phase 2
- Sponsor
- Hospital de Basurto
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- postoperative ileus
Overview
Brief Summary
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay
Detailed Description
Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with loop ileostomy
- •Barium transit throught the efferent limb without leaks
Exclusion Criteria
- •Chemotherapy at the moment
- •Ileostomy closure at the same admission than the ileostomy creation
Outcomes
Primary Outcomes
postoperative ileus
Time Frame: during the admission for the ileostomy closure
Need for a nasogastric tube
bowel movement
Time Frame: during the admission for the ileostomy closure
day of hospital stay whe stool or flatus begins
Secondary Outcomes
- hospital stay(during the admission for the ileostomy closure)
Investigators
ALBA VÁZQUEZ-MELERO
General Surgeon
Hospital de Basurto
Study Sites (1)
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