Stimulation of the Efferent Loop Before Loop Ileostomy Closure

January 31, 2018 updated by: ALBA VÁZQUEZ-MELERO, Hospital de Basurto
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48002
        • Recruiting
        • Hospital De Basurto
        • Contact:
        • Principal Investigator:
          • Alba Vázquez-Melero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non stimulated
Prospective data obtained from non stimulated patients
Experimental: Stimulated
Prospective data obtaied from stimulated patients
Procedure: efferent limb stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative ileus
Time Frame: during the admission for the ileostomy closure
Need for a nasogastric tube
during the admission for the ileostomy closure
bowel movement
Time Frame: during the admission for the ileostomy closure
day of hospital stay whe stool or flatus begins
during the admission for the ileostomy closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay
Time Frame: during the admission for the ileostomy closure
days
during the admission for the ileostomy closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Basurto

Collaborators

Alberto Loizate Totoricaguena
Pedro García Alonso

Investigators

  • Principal Investigator: Alba Vázquez-Melero, general surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 20, 2014

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

October 30, 2018

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Hospital de Basurto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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