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Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Colorectal Transport

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274312
First Posted: January 11, 2011
Last Update Posted: May 12, 2014
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.
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
University of Aarhus
  Purpose

Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder dysfunction. Recently, the concept of a surgically created somato-sensory reflex arch for bladder dysfunction in SCI has been introduced. The concept is promising, not just for bladder but also for bowel dysfunction. However, well designed studies need to be performed before recommending the procedure to a large number of patients worldwide. In this study the investigators perform multidisciplinary studies providing necessary information about the clinical outcome of the somato-sensory reflex arch in adult SCI patients.

The hypothesis is as follows:

  1. Somato-sensory reflex arch increases colorectal transport between defecations
  2. Somato-sensory reflex arch improves colorectal emptying at defecation

Condition Intervention
Spinal Cord Injuries Procedure: Xiao procedure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Colorectal Transport

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Colorectal emptying [ Time Frame: 18 month postoperative for last included patient ]
    Colorectal emptying at defecation after somato-autonomic reflex stimulation is mesaured using colorectal scintigraphy pre- and 18 month postoperatively


Secondary Outcome Measures:
  • Colorectal transport during somato-autonomic reflex stimulation [ Time Frame: 18 month postoperative for last included patient ]
    Colorectal transport during somato-autonomic reflex stimulation is meseaured using colorectal scintigraphy pre- and 18 month postoperatively

  • Colorectal transport at defecation [ Time Frame: 18 month postoperative for last included patient ]
    Colorectal transport at defecation in patients with spinal cord lesions is meseaured using colorectal scintigraphy pre- and 18 month postoperative


Enrollment: 10
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Xiao procedure
    Cross over surgery. Proximal part of L5 Ventral root is anastomosed to distal part of ventral root of S2 or S3 producing a somato-sensory reflex arch
    Other Names:
    • Somato-sensory reflex arch
    • Artificial somato-sensory reflex arch
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 years of age or above with motoric complete Spinal cord injury medullary level C4-L4
  • Preserved Hamstring reflex (L5)
  • Participation acceptance in verbal and writing

Exclusion Criteria:

  • Respiratory dependent patient
  • Baclofen pump
  • Malignancy in the urinary tract, surgery on the urinary tract, urethral strictures
  • Ileostomy, Colostomy or radiation towards the area
  • Pregnancy, for men planning a pregnancy with their partner
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274312


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Lundbeck Foundation
Investigators
Principal Investigator: Klaus Krogh, PhD, DmSc Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01274312     History of Changes
Other Study ID Numbers: M-20090113 - 1
First Submitted: November 8, 2010
First Posted: January 11, 2011
Last Update Posted: May 12, 2014
Last Verified: October 2012

Keywords provided by University of Aarhus:
Somato-sensory reflex arch
Spinal cord injury
Xiao Procedure

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System