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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:
Researchers will compare the local made colonic capsule with the standard Sitzmark colonic capsule to see the correlation.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 10 participants with chronic constipation according to Rome IV criteria and 10 healthy volunteers will receive 1 Sitzmark colonic capsule (contains 24 radiopaque markers) and 4 Siriraj gastrointestinal transit capsule (each contains 6 radiopaque markers). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siriraj gastrointestinal transit capsule | Device | The Siriraj gastrointestinal transit capsule is a local made colonic transit capsule. Each capsule contains 6 circular-shaped radiopaque markers. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation in the number of retained radiopaque markers from abdominal x-ray | The correlation in the number of retained radiopaque markers in abdominal x-ray between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule. | 5 days after intervention |
| Correlation in the diagnosis of slow transit constipation with radiopaque marker method | 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. | 5 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of Siriraj gastrointesinal transit capsule | 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. | 5 days after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkoknoi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28738452 | Background | Jaruvongvanich V, Patcharatrakul T, Gonlachanvit S. Prediction of Delayed Colonic Transit Using Bristol Stool Form and Stool Frequency in Eastern Constipated Patients: A Difference From the West. J Neurogastroenterol Motil. 2017 Oct 30;23(4):561-568. doi: 10.5056/jnm17022. | |
| 31847098 | Background | Sharif H, Devadason D, Abrehart N, Stevenson R, Marciani L. Imaging Measurement of Whole Gut Transit Time in Paediatric and Adult Functional Gastrointestinal Disorders: A Systematic Review and Narrative Synthesis. Diagnostics (Basel). 2019 Dec 13;9(4):221. doi: 10.3390/diagnostics9040221. |
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|
| Sitz-Markers | Device | The standard Sitzmark colonic capsule containing 24 ring-shaped radiopaque markers. |
|
| 30681255 | Background | Bharucha AE, Anderson B, Bouchoucha M. More movement with evaluating colonic transit in humans. Neurogastroenterol Motil. 2019 Feb;31(2):e13541. doi: 10.1111/nmo.13541. |
| 31945360 | Background | Bharucha AE, Lacy BE. Mechanisms, Evaluation, and Management of Chronic Constipation. Gastroenterology. 2020 Apr;158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034. Epub 2020 Jan 13. |