Chronic Constipation, Colonic Transit, Colonic Transit Capsule, Radiopaque Marker, Slow Transit Constipation
Conditions
Keywords
Chronic constipation, Slow transit constipation, Colonic transit, Colonic transit capsule, Radiopaque marker, Diagnostic accuracy
Brief summary
The goal of this clinical trial is to learn if the local made colonic transit capsule can be use to diagnose slow transit constipation. The main questions it aims to answer are: * Does the local made colonic transit capsule correlate with the standard colonic capsule in the diagnosis of slow transit constipation? * Does the number of remained radiopaque marker similar between the two test after five days of ingestion? Researchers will compare the local made colonic capsule with the standard Sitzmark colonic capsule to see the correlation. Participants will: * Take both local made colonic capsule and Sitzmark colonic capsule at the same time. * Obtain abdominal x-ray 5 days after capsule ingestion. * Keep a diary of their symptoms and medication used during investigation.
Detailed description
The accurate diagnosis of constipation subtype is crucial especially in patients refractory to treatment. The current methods are expensive and not widely available. Thus, the investigators design the clinical study to evaluate the correlation and diagnostic accuracy of local made colonic transit capsule (Siriraj gastrointestinal transit capsule) compare with standard colonic capsule. The patients with constipation and healthy volunteers will be enrolled. Participants will be asked to take both Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule. The two capsules have different shape of radiopaque marker. The abdominal x-ray will be taken 5 days later. The number of radiopaque marker left will be counted separately between the two type of markers. Slow transit constipation is defined with retained more than 20% of radiopaque marker at 5 days after ingestion. Primary outcome is the correlation in the diagnosis of slow transit constipation and number of remained radiopaque markers between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule and the secondary outcome is the diagnostic performance of Siriraj gastrointestinal transit capsule in detecting slow transit constipation with Sitzmark colonic capsule as standard reference.
Interventions
DEVICESiriraj gastrointestinal transit capsule
The Siriraj gastrointestinal transit capsule is a local made colonic transit capsule. Each capsule contains 6 circular-shaped radiopaque markers.
DEVICESitz-Markers
The standard Sitzmark colonic capsule containing 24 ring-shaped radiopaque markers.
Sponsors
Mahidol University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers with normal bowel habit not meet the criteria for functional constipation and irritable bowel syndrome with constipation according to Rome IV criteria * Participants with constipation according to Rome IV criteria
Exclusion criteria
* Previous abdominal surgery * Participants at risk for intestinal obstruction such as endometriosis, history of intra-abdominal infection * Receive medication which affect colonic transit such as opioids * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation in the number of retained radiopaque markers from abdominal x-ray | 5 days after intervention | The correlation in the number of retained radiopaque markers in abdominal x-ray between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule. |
| Correlation in the diagnosis of slow transit constipation with radiopaque marker method | 5 days after intervention | The correlation in the diagnosis of slow transit constipation between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule defined as retained 20% or more of radiopaque marker in abdominal x-ray after 5 days of ingestion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of Siriraj gastrointesinal transit capsule | 5 days after intervention | The diagnostic performance of Siriraj gastrointestinal transit capsule in the diagnosis of slow transit constipation defined as retained 20% or more of radiopaque marker in abdominal x-ray after 5 days of ingestion with Sitzmark colonic capsule as reference standard defined as sensitivity, specificity, PPV, NPV. |
Countries
Thailand
Outcome results
None listed