Colonic Neoplasms, Diverticulitis, Colonic
Conditions
Keywords
Diverticulitis, Advanced colonic neoplasm, Colonoscopy
Brief summary
This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be made in order to determinate whether there are differences of advanced colonic neoplasia (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.
Detailed description
This is a prospective study that eliminates biases in the selection, design and variability of retrospective studies to reliably assess the global prevalence of advanced colon neoplasia (ACN) and the difference in prevalence among populations with complicated and uncomplicated acute diverticulitis diagnosed by computed tomography. Another objective is to assess the diagnostic prediction of computed tomography to detect ACN in acute diverticulitis. It also aims to assess the safety and quality of colonoscopy in a patient recently diagnosed with acute diverticulitis. Finally, it aims to study whether other diagnostic tools such as the presence of clinical risk symptoms or the performance of fecal biological tests could help in narrowing the indication of colonoscopy in this clinical scenario.
Interventions
DIAGNOSTIC_TESTColonoscopy
Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities
DIAGNOSTIC_TESTFecal immunochemical and occult blood test
A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.
DIAGNOSTIC_TESTFecal calprotectin test
Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.
Sponsors
Parc de Salut Mar
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Diagnostic clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
All patients consecutively diagnosed with acute diverticulitis in the participating hospitals during the study inclusion period will be included. For this purpose, a multidetector computerized tomography confirming the diagnosis of acute diverticulitis must be performed on all patients with initial clinical suspicion.
Exclusion criteria
1. Patient refusal to participate in the study. 2. Impossibility of obtaining informed consent by the patient or guardian. 3. Age \<18 years and\> 85 years 4. Impossibility of performing a diagnostic CT of AD. 5. Intercurrent medical or surgical process with prolonged recovery in time that prevents a colonoscopy before 6 months after the resolution of the episode of acute diverticulitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of ACN | At the moment of colonoscopy. | For our study, ANC is all colonic lesions that are advanced adenoma or colorectal cancer. Advanced adenoma is defined as that adenoma with size\> 10mm, villous component in\> 25% and / or high-grade dysplasia or all serrated lesions\> 10mm with or without dysplasia. Colonoscopy is the gold standard for ANC detection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical symptoms predictive value for ANC detection | At the moment of colonoscopy. | Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis. |
| Colonoscopy quality | At the moment of colonoscopy. | A quality colonoscopy will be considered as a complete colonoscopy, with an adequate preparation according to the Boston scale (score greater than or equal to 2 in all segments) and with resection of all polyps \<20mm detected. |
| CT predictive value for ACN detection | At the moment of colonoscopy. | Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis. |
| FIT predictive value for ANC detection | At the moment of colonoscopy. | Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis. |
| Fecal calprotectin test predictive value for ANC detection | At the moment of colonoscopy. | Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis. |
| Colonoscopy security | 30 days post-colonoscopy. | Assessment of complications arising from colonoscopy. Mayor complication of colonoscopy is defined as the presence of perforation, hemorrhage, postpolypectomy syndrome, thromboembolic accident, acute myocardial infarction and / or death, and minor complication of colonoscopy for the rest of the events. |
Countries
Spain
Outcome results
None listed