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

Completed

• Conditions: Systemic Sclerosis

• Registration Number: NCT00213460
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Study Completion: 2003-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

CHU Rouen; 🇫🇷 Rouen, Rouen Cedex, France