Clinico-radiological Classification of Peritoneal Tuberculosis

NCT03927664 | Completed

• 1 other identifier: NK/5243/Study/019
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tuberculosis; Tuberculosis; Abdomen (Etiology); Tuberculosis, Peritoneal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Peritoneal Tuberculosis

Patients diagnosed with peritoneal tuberculosis and who have undergone a computed tomographic examination

Other: Radiological assessment

Interventions

Radiological assessment OTHER

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

Peritoneal Tuberculosis

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with peritoneal tuberculosis or being treated as peritoneal tuberculosis

You may qualify if:

• Patients diagnosed with peritoneal tuberculosis
• Patients who have undergone a computed tomographic examination

You may not qualify if:

• Age \< 12
• Unclear diagnosis
• More than one etiology for ascites
• Not willing for consent

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160036, India

Location

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

Chandigarh, India

Location

Related Publications (1)

• 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.

  PMID: 31293195 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Peritonitis, Tuberculous

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Extrapulmonary; Peritonitis; Intraabdominal Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Vishal Sharma

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

IN (2)