Tuberculosis Clinical Trial
Official title:
Conception and Validation of a Clinico-radiological Classification of Peritoneal Tuberculosis
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.
The study will be conducted as two parts
1. Derivation group:
Screening population: Patients with abdominal tuberculosis treated in the
gastroenterology unit from Jan 2017-Dec 2018 This will involve a retrospective study
where the patients who have been treated for peritoneal tuberculosis and have full
records available (as hospital records or Gut-Tuberculosis clinic files) will be
included and their clinical details and radiological findings (from CT films or images)
will be entered and compared. The radiological findings between these groups will be
compared if findings on radiology are discriminative of these three patterns of
presentation.
2. Validation Study: This will include prospective study of patients who have underwent
computed tomography for evaluation of abdominal complaints and are eventually diagnosed
to have peritoneal tuberculosis. The radiological parameters derived from the derivation
group will be tested to predict the clinical presentation.
At the end of the study,the feasibility of a clinico-radiological classification of
peritoneal tuberculosis.
The clinical details will be recorded and will include demographic details, diagnostic
work-up (confirmed/probable), follow-up and classification into one of the three patterns of
presentation
1. Distension dominant: Presence of abdominal distention or discomfort, Lack of pain
2. Pain dominant: Patients having associated significant abdominal pain necessitating
analgesics or interfering with routine activities
3. Obstruction dominant; Clear historical and/or radiological evidence of intestinal
obstruction like abdominal pain associated with distension and obstipation
Computed tomographic scans/images will be assessed by the two radiologists separately and
resolved by consensus The radiologists will not have access to any clinical details The
findings will be recorded on a proforma and will include determination of presence and extent
of ascites, loculated ascites, peritoneal nodules or masses, omental involvement as nodules
or masses, mesenteric adenopathy, masses, abdominal lymphadenopathy, presence of clumped
loops, adhesions, abdominal cocoon etc The three groups will be compared for these
radiological patterns and a possible correlation between any radiological findings and the
clinical presentation will be derived.
The classification derived from the derivation cohort will be tested in validation cohort
which will be a prospective study. The clinical presentation will be recorded. The CT scans
will be reviewed by two radiologists blinded to clinical details and the clinical
presentation will be compared with categorisation based on the radiological findings.
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