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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complicated diverticulitis | Experimental | Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. |
|
| Uncomplicated diverticulitis | Experimental | Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the moment of colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| CT predictive value for ACN detection | Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis. | At the moment of colonoscopy. |
| Clinical symptoms predictive value for ANC detection |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| AgustÃn Seoane Urgorri, MD | Parc de Salut Mar. Hospital del Mar. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc de Salut Mar. Hospital del Mar. | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26453777 | Background | Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology. 2015 Dec;149(7):1944-9. doi: 10.1053/j.gastro.2015.10.003. Epub 2015 Oct 8. No abstract available. | |
| 24434085 | Background |
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De-identified individual participant data for all primary and secondary outcome measures will be made available
Data will be available within 6 months of study completion
Data access will be shared with the principal investigators of all the hospitals that participate in the study
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| ID | Term |
|---|---|
| D004239 | Diverticulitis, Colonic |
| D003110 | Colonic Neoplasms |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D009780 | Occult Blood |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Diagnostic clinical trial
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| Fecal immunochemical and occult blood test | Diagnostic 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. |
|
|
| Fecal calprotectin test | Diagnostic 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. |
|
Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.
| 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. | 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. | 30 days post-colonoscopy. |
| FIT predictive value for ANC detection | Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis. | 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. | At the moment of colonoscopy. |
| Daniels L, Unlu C, de Wijkerslooth TR, Dekker E, Boermeester MA. Routine colonoscopy after left-sided acute uncomplicated diverticulitis: a systematic review. Gastrointest Endosc. 2014 Mar;79(3):378-89; quiz 498-498.e5. doi: 10.1016/j.gie.2013.11.013. Epub 2014 Jan 14. No abstract available. |
| 18523784 | Background | Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4. |
| D043963 | Diverticulosis, Colonic |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |