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Completed

NCT Number: NCT00213460

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

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rouen

Rouen, Rouen Cedex, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Sep 21, 2005
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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