Thermography in Surveillance of Ulcerative Colitis

University Hospital Dubrava

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Device: Thermography; Procedure: Colonoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02149043

THERMO-01

Details and patient eligibility

About

Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.

Full description

Hypothesis: Documenting pathological thermographic signs in patients with extensive ulcerative colitis investigators will demonstrate pathological thermography criteria that correlate with standard inflammatory markers such as Mayo endoscopic subscore (ESS), CRP and calprotectin in patients with ulcerative colitis.

Aims: The aim of this study is to record abdominal thermographic images of patients with active ulcerative colitis (UC), to create interpretational thermographic criteria for these images and to compare them to abdominal infrared (IR) images of healthy volunteers. Furthermore, investigators intend to correlate these criteria with standard markers of inflammation such as CRP and calprotectin in patients with UC at the beginning of treatment and at the end.

Materials and methods: For the purpose of this work, 36 patients with extensive UC and 30 healthy individuals will be put throe thermographic imagining, have their stool tested for calprotectin and their blood for CRP. In addition, patients with UC will receive colonoscopy evaluations.

Expected scientific contribution: The results of this paper would give an additional contribution to existing tools for pursuing ulcerative colitis activity thus demonstrating the potential of thermography as a complementary method to standard methods in assessing disease activity. Establishing diagnostic criteria for this method would be a good addition to present clinical practice.

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Endoscopic diagnosis of active extensive ulcerative colitis
• Stool Calprotectin > 150 mcg/g
• CRP > 5 mg/L
• Signed informed consent form

Exclusion criteria

• Inability to preform total colonoscopy
• Marked abdominal comorbidities
• Prior abdominal surgery

Trial design

66 participants in 2 patient groups

Ulcerative Colitis patients

Description:

30 patients with active ulcerative colitis will be put throe thermography and colonoscopy. Their stool will be tested for fecal calprotectin and their blood for CRP and other laboratory measures.

Treatment:

Procedure: Colonoscopy

Device: Thermography

Healthy volunteers

Description:

30 healthy individuals matching sex and BMI to those of ulcerative colitis patients will be put throe thermography and have their stool tested for fecal calprotectin and their blood for CRP.

Treatment:

Device: Thermography