Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and … (NCT01392365) | Clinical Trial Compass
CompletedNot Applicable
Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
South Korea117 participantsStarted 2011-07
Plain-language summary
The aim of this study is to develop a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease.
Who can participate
Age range16 Years
SexALL
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Final diagnostic criteria:
* Crohn' disease (at least two of the following is met)
1. Clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
2. Endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
3. Radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
4. Macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
5. Pathologic findings of transmural inflammation and/or epithelioid granulomas
* Intestinal tuberculosis(at least one of the following is met)
1. Histologic evidence of caseating granulomas
2. Histologic demonstration of acid-fast bacilli
3. Growth of M. tuberculosis on tissue culture
4. Clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere
5. Response to antituberculous therapy without subsequent recurrence in patients with clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis
Exclusion Criteria:
* Refusal to participate in the study
* Age: 15 years or younger
* Comorbidity with acute infectious disease
* Pregnancy
* Previous history of medication including anti-TB drugs, immunosuppressive drugs, and chemotherapeutic agents\\
* Use of antibiotics within the previous three months
What they're measuring
1
Final diagnosis (Intestinal tuberculosis or Crohn's disease)
Timeframe: 6 months (In a subset of patients, for diagnosis of intestinal tuberculosis, final colonoscopic evaluation after completion of 6-months anti-tuberculous medication is needed)