Stimulation of the Efferent Loop Before Loop Ileostomy Closure

NCT ID: NCT03424447

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-20

Study Completion Date

2018-10-30

Brief Summary

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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

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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.

Conditions

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Ileostomy - Stoma Ileostomy; Complications Stoma Ileostomy Ileus Paralytic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Ambispective cohort study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Non stimulated

Prospective data obtained from non stimulated patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Stimulated

Prospective data obtaied from stimulated patients

Group Type EXPERIMENTAL

efferent limb stimulation

Intervention Type PROCEDURE

Interventions

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efferent limb stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberto Loizate Totoricaguena

UNKNOWN

Sponsor Role collaborator

Pedro García Alonso

UNKNOWN

Sponsor Role collaborator

Hospital de Basurto

OTHER

Sponsor Role lead

Responsible Party

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ALBA VÁZQUEZ-MELERO

General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alba Vázquez-Melero

Role: PRINCIPAL_INVESTIGATOR

general surgeon

Locations

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Hospital de Basurto

Bilbao, Vizcaya, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alba Vázquez-Melero

Role: CONTACT

Alberto Loizate

Role: CONTACT

Facility Contacts

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Alba Vázquez-Melero

Role: primary

Other Identifiers

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Hospital de Basurto

Identifier Type: -

Identifier Source: org_study_id

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