Stimulation of Efferent Loop Prior to Ileostomy Closure

June 17, 2013 updated by: Juan Lujan, Hospital Universitario Virgen de la Arrixaca
The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • protective ileostomy after rectal cancer surgery

Exclusion Criteria:

  • under 18 years

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No stimulation
unstimulated patients prior to surgery,ileostomy closure surgery without prior stimulation of efferent limb.
Procedure: Procedure/Surgery
daily stimulation of efferent loop prior to surgery (ileostomy closure)
Other Names:
  • Stimulation
Experimental: Stimulation
stimulation of the efferent limb of the ileostomy prior to ileostomy closure.
Procedure: Procedure/Surgery
daily stimulation of efferent loop prior to surgery (ileostomy closure)
Other Names:
  • Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative ileus
Time Frame: within the first days after surgery
within the first days after surgery

Collaborators and Investigators

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

Sponsor

Hospital Universitario Virgen de la Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEL-001

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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