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NCT01881594 Clinical Trial

Stimulation of Efferent Loop Prior to Ileostomy Closure

Ileostomy; Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01881594
Other study ID # SEL-001
Secondary ID
Status Completed
Phase Phase 3
First received April 29, 2013
Last updated June 17, 2013
Start date January 2012

Study information
Verified date June 2013
Source Hospital Universitario Virgen de la Arrixaca
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.

Description:

Stimulation was performed ten days prior to the intervention, through the efferent limb of the ileostomy with 500 cc of a thickening substance (saline and nutritional thickener)

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- protective ileostomy after rectal cancer surgery

Exclusion Criteria:

- under 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Procedure/Surgery
daily stimulation of efferent loop prior to surgery (ileostomy closure)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Virgen de la Arrixaca

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative ileus within the first days after surgery Yes
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