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NCT03424447 Clinical Trial

Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Ileostomy - Stoma Clinical Trial

Official title:
Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03424447
Other study ID # Hospital de Basurto
Secondary ID
Status Recruiting
Phase Phase 2
First received January 31, 2018
Last updated January 31, 2018
Start date November 20, 2014
Est. completion date October 30, 2018

Study information
Verified date January 2018
Source Hospital de Basurto
Contact Alba Vázquez-Melero
Email albav6@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date October 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• efferent limb stimulation

Locations
Country Name City State
Spain Hospital de Basurto Bilbao Vizcaya

Sponsors (3)
Lead Sponsor Collaborator
Hospital de Basurto Alberto Loizate Totoricaguena, Pedro García Alonso

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative ileus Need for a nasogastric tube during the admission for the ileostomy closure
Primary bowel movement day of hospital stay whe stool or flatus begins during the admission for the ileostomy closure
Secondary hospital stay days during the admission for the ileostomy closure
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