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

NCT ID: NCT00213460

Last Updated: 2013-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle MARIE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Locations

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CHU Rouen

Rouen, Rouen Cedex, France

Site Status

Countries

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France

Other Identifiers

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2000/103/HP

Identifier Type: -

Identifier Source: org_study_id

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