Stimulation of the Efferent Loop Before Loop Ileostomy Closure

Phase 2

• Conditions: Ileostomy - Stoma; Stoma Ileostomy; Ileostomy; Complications; Ileus Paralytic
• Interventions: Procedure: efferent limb stimulation

• Registration Number: NCT03424447
• Lead Sponsor: Hospital de Basurto

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11-20
• Status Verified: 2018-01
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Study First Posted: 2018-02-07
• Last Update Posted: 2018-02-07
• Primary Completion: 2018-06-30
• Study Completion: 2018-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stimulated	efferent limb stimulation	Prospective data obtaied from stimulated patients

Primary Outcome Measures

Name	Time	Method
postoperative ileus	during the admission for the ileostomy closure	Need for a nasogastric tube
bowel movement	during the admission for the ileostomy closure	day of hospital stay whe stool or flatus begins

Secondary Outcome Measures

Name	Time	Method
hospital stay	during the admission for the ileostomy closure	days

Trial Locations

Locations (1)

Hospital de Basurto; 🇪🇸 Bilbao, Vizcaya, Spain