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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:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213460
First received: September 13, 2005
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213460     History of Changes
Other Study ID Numbers: 2000/103/HP
Study First Received: September 13, 2005
Last Updated: April 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 21, 2013