Cystic FibrosisNCT04613063
Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
An observational study of Cystic Fibrosis and Bowel Obstruction, run by Tecnologico de Monterrey at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Cystic Fibrosis, Bowel Obstruction, Distal Intestinal Obstruction Syndrome
- What is being tested?
- Diagnostic laparoscopy
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 19 Oct 2020to 21 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 45 years old patient with cystic fibrosis
Who may be able to join
- Adult >18 years
- Cystic fibrosis
- Bowel obstruction
Who cannot join
- Pediatric patient <18 years
- Unknown cause of bowel obstruction
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Escuela Nacional de Medicina, Tecnologico de Monterrey
Monterrey, Nuevo León, 76140
About this study
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.
Read the 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.
- Being tested
- Diagnostic laparoscopy
- Medical subject headings
- Cystic Fibrosis, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic laparoscopyOther
A diagnostic laparoscopy was performed where a dilated jejunum was encountered with impaction of fecal content. Surgery was converted to open surgery, where a longitudinal enterotomy of 5 cm after the transition zone was created, evacuating manually the fecal material with mucous secretion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel obstruction in a patient with cystic fibrosis
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.
Measured: 3-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start19 Oct 2020
- Primary completion20 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnologico de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613063
- Sponsor's protocol ID
- I1568Z
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome
- ClinicalTrials.gov ID
- NCT04613063
- Acronym / sponsor ID
- I1568Z
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tecnologico de MonterreyUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 45 years old patient with cystic fibrosis
Key inclusion criteria (3 listed)
- Adult >18 years
- Cystic fibrosis
- Bowel obstruction
Key exclusion criteria (2 listed)
- Pediatric patient <18 years
- Unknown cause of bowel obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic laparoscopyA diagnostic laparoscopy was performed where a dilated jejunum was encountered with impaction of fecal content. Surgery was converted to open surgery, where a longitudinal enterotomy of 5 cm after the transition zone was created, evacuating manually the fecal material with mucous secretion. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Bowel Obstruction, run by Tecnologico de Monterrey at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel obstruction in a patient with cystic fibrosis (time frame: 3-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.