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Stimulation of the Efferent Loop Before Loop Ileostomy Closure

H

Hospital de Basurto

Status and phase

Unknown
Phase 2

Conditions

Ileostomy - Stoma
Stoma Ileostomy
Ileostomy; Complications
Ileus Paralytic

Treatments

Procedure: efferent limb stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03424447
Hospital de Basurto

Details and patient eligibility

About

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

Full 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.

Enrollment

140 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Non stimulated
No Intervention group
Description:
Prospective data obtained from non stimulated patients
Stimulated
Experimental group
Description:
Prospective data obtaied from stimulated patients
Treatment:
Procedure: efferent limb stimulation

Trial contacts and locations

1

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Central trial contact

Alberto Loizate; Alba Vázquez-Melero

Data sourced from clinicaltrials.gov

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