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Status unknownNCT03424447Updated Feb 7, 2018

Stimulation of the Efferent Loop Before Loop Ileostomy Closure

A Phase 2 interventional study of efferent limb stimulation in Ileostomy - Stoma, Ileostomy; Complications and Stoma Ileostomy, sponsored by Hospital de Basurto. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by Hospital de Basurto · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Ileostomy - Stoma
  • Ileostomy; Complications
  • Stoma Ileostomy
  • Ileus Paralytic
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with loop ileostomy
  • Barium transit throught the efferent limb without leaks

Exclusion criteria

Exclusion Criteria:

  • Chemotherapy at the moment
  • Ileostomy closure at the same admission than the ileostomy creation
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • No intervention
    Non stimulated

    Prospective data obtained from non stimulated patients

  • Experimental
    Stimulated

    Prospective data obtaied from stimulated patients

    Procedure: efferent limb stimulation

Interventions

  • Procedureefferent limb stimulation
05

What researchers measure

Primary outcomes

  1. postoperative ileus

    Need for a nasogastric tube

    Time frame: during the admission for the ileostomy closure

  2. bowel movement

    day of hospital stay whe stool or flatus begins

    Time frame: during the admission for the ileostomy closure

Secondary outcomes

  1. hospital stay

    days

    Time frame: during the admission for the ileostomy closure

06

Study locations

1 of 1 sites recruiting
  • Hospital de Basurto
    Bilbao, Vizcaya 48002, Spain
    • Alba Vázquez-Melero · Contact · albav6@hotmail.com
    • Alba Vázquez-Melero · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03424447
Lead sponsor
Hospital de Basurto
Collaborators
Alberto Loizate Totoricaguena, Pedro García Alonso
Responsible party
ALBA VÁZQUEZ-MELERO (General Surgeon, Hospital de Basurto) — Principal investigator
First posted
Feb 7, 2018
Start date
Nov 20, 2014
Primary completion
Jun 30, 2018 (estimated)
Completion
Oct 30, 2018 (estimated)
Last update
Feb 7, 2018

Study contacts

Alba Vázquez-Melero
Contact
albav6@hotmail.com
Alba Vázquez-Melero
principal investigator · general surgeon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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