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Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213460
First Posted: September 21, 2005
Last Update Posted: April 16, 2013
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.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose

Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death.

In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc.

The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.


Condition
Systemic Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Study Start Date: August 2001
Study Completion Date: July 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with systemic sclerosis, who had an upper intestinal tract manometry 5 years before, with:

    • age over 18 years
    • written informed consent

Exclusion Criteria:

  • pregant women
  • patients with psychiatric conditions
  • unwritten informed consent
  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): NCT00213460


Locations
France
CHU Rouen
Rouen, Rouen Cedex, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Isabelle MARIE, MD, PhD CHU Rouen
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213460     History of Changes
Other Study ID Numbers: 2000/103/HP
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: April 16, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases