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Stimulation of Efferent Loop Prior to Ileostomy Closure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881594
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Juan Lujan, Hospital Universitario Virgen de la Arrixaca

Brief Summary:
The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.

Condition or disease Intervention/treatment Phase
Ileostomy; Complications Procedure: Procedure/Surgery Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : September 2012

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 Name: 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 Name: Stimulation




Primary Outcome Measures :
  1. postoperative ileus [ Time Frame: within the first days after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • protective ileostomy after rectal cancer surgery

Exclusion Criteria:

  • under 18 years

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juan Lujan, Section chief. Coloproctology department., Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT01881594    
Other Study ID Numbers: SEL-001
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Juan Lujan, Hospital Universitario Virgen de la Arrixaca:
ileostomy closure,postoperative ileus,stimulation ileostomy