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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Digestive System Diseases Gram-Positive Bacterial Infections Infections Intraabdominal Infections Mycobacterium Infections Peritoneal Diseases Peritonitis Peritonitis, Tuberculous Tuberculosis, Extrapulmonary Tuberculosis, Peritoneal Tuberculosis; Abdomen (Etiology)

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India

About this study

The study will be conducted as two parts

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.

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

Distension dominant: Presence of abdominal distention or discomfort, Lack of pain
Pain dominant: Patients having associated significant abdominal pain necessitating analgesics or interfering with routine activities
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiological assessment

Other

Radiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings

Primary outcomes

Correlation of radiological characterization of classification with clinical presentation

Time frame: 3 months of diagnosis

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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Conception and Validation of a Clinico-radiological Classification of Peritoneal Tuberculosis

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 25, 2019
Registry last updated: Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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