An interventional study of Colonoscopy and Fecal immunochemical and occult blood test in Diverticulitis, Colonic and Colonic Neoplasms, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Diagnostic
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.
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.
27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.
This study's enrollment of 313 is above the median of 142 across 10 interventional studies indexed under Diverticulitis, Colonic.
Browse Diverticulitis, Colonic studies →Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 25 are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.
Diagnostic Test: Colonoscopy · Diagnostic Test: Fecal immunochemical and occult blood test · Diagnostic Test: Fecal calprotectin test
Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.
Diagnostic Test: Colonoscopy · Diagnostic Test: Fecal immunochemical and occult blood test · Diagnostic Test: Fecal calprotectin test
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
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.
Also known as: FIT
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.
Presence of ACN
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.
Time frame: At the moment of colonoscopy.
CT predictive value for ACN detection
Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.
Time frame: At the moment of colonoscopy.
Clinical symptoms predictive value for ANC detection
Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.
Time frame: At the moment of colonoscopy.
Colonoscopy quality
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.
Time frame: At the moment of colonoscopy.
Colonoscopy security
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.
Time frame: 30 days post-colonoscopy.
FIT predictive value for ANC detection
Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.
Time frame: At the moment of colonoscopy.
Fecal calprotectin test predictive value for ANC detection
Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.
Time frame: At the moment of colonoscopy.
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available within 6 months of study completion
Access criteria: Data access will be shared with the principal investigators of all the hospitals that participate in the study
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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