NCT04613063

Brief 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 jejunum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1 day

First QC Date

October 21, 2020

Last Update Submit

October 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-6 days

Interventions

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.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

45 years old patient with cystic fibrosis

You may qualify if:

  • Adult \>18 years
  • Cystic fibrosis
  • Bowel obstruction

You may not qualify if:

  • Pediatric patient \<18 years
  • Unknown cause of bowel obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela Nacional de Medicina, Tecnologico de Monterrey

Monterrey, Nuevo León, 76140, Mexico

Location

MeSH Terms

Conditions

Cystic FibrosisIntestinal Obstruction

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesIntestinal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 3, 2020

Study Start

October 19, 2020

Primary Completion

October 20, 2020

Study Completion

October 21, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations