- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04613063
Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
October 27, 2020 updated by: Tecnologico de Monterrey
A case of a patient with cystic fibrosis with bowel obstruction due to a proximal intestinal obstruction syndrome (PIOS) is presented.This syndrome can be diagnosed with the DIOS definition, with the only distinction of a more proximal location in the gastrointestinal tract, such as the stomach, the duodenum, or the jejunum.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Distal Intestinal Obstruction Syndrome is a rare complication in cystic fibrosis patients characterized by the accumulation of viscid fecal material, combined with sticky mucous secretions located in the distal ileum, adhered to the intestinal wall.
Only few cases have been reported in the literature.
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 76140
- Escuela Nacional de Medicina, Tecnologico de Monterrey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
45 years old patient with cystic fibrosis
Description
Inclusion Criteria:
- Adult >18 years
- Cystic fibrosis
- Bowel obstruction
Exclusion Criteria:
- Pediatric patient <18 years
- Unknown cause of bowel obstruction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bowel obstruction in a patient with cystic fibrosis
Time Frame: 3-6 days
|
A 45 year old patient with cystic fibrosis presented with bowel obstruction.
Image studies were performed, without identifying a specific cause of the bowel obstruction.
The patient was transferred to surgery.
|
3-6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2020
Primary Completion (Actual)
October 20, 2020
Study Completion (Actual)
October 21, 2020
Study Registration Dates
First Submitted
October 21, 2020
First Submitted That Met QC Criteria
October 27, 2020
First Posted (Actual)
November 3, 2020
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 27, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I1568Z
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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