Tuberculosis Clinical Trial
Official title:
Conception and Validation of a Clinico-radiological Classification of Peritoneal Tuberculosis
NCT number | NCT03927664 |
Other study ID # | NK/5243/Study/019 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | July 30, 2020 |
Verified date | August 2020 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Traditionally, peritoneal tuberculosis has been classified as wet-ascitic, dry-plastic type
and fibrotic -fixed types. there is substantial overlap between these definitions and the
clinical implication of the categorisation into the three patterns is unclear.
The clinical presentation will be used to divide participants into 1) Abdominal distension
dominant disease or 2) Pain Dominant and/or 3) Obstruction dominant peritoneal tuberculosis.
The radiological findings between these groups will be compared if findings on radiology are
discriminative of these three patterns of presentation.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria - Patients diagnosed with peritoneal tuberculosis - Patients who have undergone a computed tomographic examination Exclusion Criteria: - Age < 12 - Unclear diagnosis - More than one etiology for ascites - Not willing for consent |
Country | Name | City | State |
---|---|---|---|
India | Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh | Chandigarh | |
India | Postgraduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Ahamed Z R, Shah J, Agarwala R, Kumar-M P, Mandavdhare HS, Gupta P, Singh H, Sharma A, Dutta U, Sharma V. Controversies in classification of peritoneal tuberculosis and a proposal for clinico-radiological classification. Expert Rev Anti Infect Ther. 2019 Aug;17(8):547-555. doi: 10.1080/14787210.2019.1642746. Epub 2019 Jul 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of radiological characterization of classification with clinical presentation | Clinical presentation will be classified as 1) Distension dominant 2) Pain dominant 3) Obstruction dominant This will be correlated with the categorisation based on radiologic findings and correlation between the radiological category an actual clinical category will be studied | 3 months of diagnosis |
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