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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01274312
First received: November 8, 2010
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Colorectal Transport

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Colorectal emptying [ Time Frame: 18 month postoperative for last included patient ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Colorectal transport at defecation in patients with spinal cord lesions is meseaured using colorectal scintigraphy pre- and 18 month postoperative


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01274312     History of Changes
Other Study ID Numbers: M-20090113 - 1
Study First Received: November 8, 2010
Last Updated: October 29, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on May 23, 2013