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Clinical Trials/NCT01881594
NCT01881594
Completed
Phase 3

Stimulation of Efferent Loop Prior to Ileostomy Closure

Hospital Universitario Virgen de la Arrixaca0 sites60 target enrollmentStarted: January 2012Last updated:
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ConditionsIleostomy; Complications

Overview

Phase
Phase 3
Status
Completed
Sponsor
Hospital Universitario Virgen de la Arrixaca
Enrollment
60
Primary Endpoint
postoperative ileus
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Detailed 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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •protective ileostomy after rectal cancer surgery

Exclusion Criteria

  • •under 18 years

Outcomes

Primary Outcomes

postoperative ileus

Time Frame: within the first days after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital Universitario Virgen de la Arrixaca
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Juan Lujan

Section chief. Coloproctology department.

Hospital Universitario Virgen de la Arrixaca

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