Stimulation of Efferent Loop Prior to Ileostomy Closure

NCT ID: NCT01881594

Last Updated: 2013-06-19

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Ileostomy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No stimulation

unstimulated patients prior to surgery,ileostomy closure surgery without prior stimulation of efferent limb.

Group Type ACTIVE_COMPARATOR

Procedure/Surgery

Intervention Type PROCEDURE

daily stimulation of efferent loop prior to surgery (ileostomy closure)

Stimulation

stimulation of the efferent limb of the ileostomy prior to ileostomy closure.

Group Type EXPERIMENTAL

Procedure/Surgery

Intervention Type PROCEDURE

daily stimulation of efferent loop prior to surgery (ileostomy closure)

Interventions

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Procedure/Surgery

daily stimulation of efferent loop prior to surgery (ileostomy closure)

Intervention Type PROCEDURE

Other Intervention Names

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Stimulation

Eligibility Criteria

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Inclusion Criteria

* protective ileostomy after rectal cancer surgery

Exclusion Criteria

* under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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Juan Lujan

Section chief. Coloproctology department.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.

Reference Type DERIVED
PMID: 25380005 (View on PubMed)

Other Identifiers

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SEL-001

Identifier Type: -

Identifier Source: org_study_id

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