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NCT00213460 Clinical Trial

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

Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00213460
Other study ID # 2000/103/HP
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated April 15, 2013
Start date August 2001
Est. completion date July 2003

Study information
Verified date April 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Rouen Rouen Rouen Cedex

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

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