<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04407793</url>
  </required_header>
  <id_info>
    <org_study_id>DICRO-2020</org_study_id>
    <nct_id>NCT04407793</nct_id>
  </id_info>
  <brief_title>Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis</brief_title>
  <acronym>DICRO</acronym>
  <official_title>Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sebastiano Biondo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      MAIN OBJECTIVE: Description of predicted markers of acute diverticulitis crisis, using&#xD;
      bivariate and multivariate analyses. Analysis of acute diverticulitis predictor swings.&#xD;
&#xD;
      SIDE OBJECTIVES: Descriptive analysis of HRQL in the different measurement periods to&#xD;
      establish the evolution of the disease. Correlate HRQL values of systemic and local&#xD;
      inflammatory markers in the diverticulitis group. Sub-analysis of patients with&#xD;
      immunosuppression to evaluate disease virulence compared to a group of patients without&#xD;
      immunosuppression.&#xD;
&#xD;
      STUDY TYPE: Clinical, observational, prospective and multicenter study (8 hospitals) with&#xD;
      three study groups: patients diagnosed with acute diverticulitis attending emergencies,&#xD;
      diverticulosis patients and patients without diverticulums. INCLUSION CRITERIA: Age &gt; 18years&#xD;
      and radiological diagnosis by abdominal CT acute diverticulitis. EXCLUSION CRITERIA:&#xD;
      Rejection of the patient -severe diverticulitis requiring urgent surgery -an inability to&#xD;
      understand HRQL questionnaire - IBD - pregnancy or breastfeeding - acute diverticulitis&#xD;
      within the prior year of the study - Roma IV criteria fulfilment. VARIABLES: Main variables:&#xD;
      local and systemic inflammatory markers- faecal calprotectin. Secondary variables: recurrence&#xD;
      of acute diverticulitis -the persistence of symptoms - SF 12 and GIQLI questionnaires.&#xD;
&#xD;
      STATISTICS: Sample size: alpha error 0.05; beta error 0.20; bilateral; proportion 0.9 in the&#xD;
      control group; 500 subjects group diverticulitis, 200 group diverticulosis and not&#xD;
      diverticulums.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GENERAL CHARACTERISTICS OF THE PROJECT:&#xD;
&#xD;
      Despite being a benign pathology, colon diverticulitis represents the fifth most important&#xD;
      gastrointestinal pathology and has a great clinical impact on the quality of life of patients&#xD;
      and on health expenditure. Understanding a disease involves being able to make the correct&#xD;
      diagnosis of the patient and most importantly for the patient, an adequate treatment of his&#xD;
      symptoms. It is required to give accurate information to the patient and answer his doubts,&#xD;
      although the pathophysiology of the disease is unknown. As it is a benign disease with&#xD;
      heterogeneous behaviours and manifestations, it is difficult to make the decision related to&#xD;
      undergo surgery. This decision could be facilitated if it is based on extensive information&#xD;
      from the doctor. It is also important to be able to select those patients who have a higher&#xD;
      risk of relapse in order to prioritize them on the waiting list for surgery. As a benign&#xD;
      disease with occupational active patient involvement, acute diverticulitis has a major&#xD;
      economic impact by leading to repeat leaves in some patients, who are even on a waiting list&#xD;
      to operate.&#xD;
&#xD;
      EXPECTED IMPACT:&#xD;
&#xD;
      We believe that this project can respond to the management of a group of patients, in which&#xD;
      there is currently no consensus in the Scientific Community. Therefore, our results are&#xD;
      transferable, as we intend to establish the pathophysiology of the entity known as chronic&#xD;
      diverticulitis and detect the predictors of that entity. Currently, there is no consensus on&#xD;
      the therapeutic management of patients with recurrent episodes of diverticulitis or&#xD;
      persistent symptoms, so that they are treated differently at the discretion of the surgeon,&#xD;
      without any scientific basis. It is also unclear whether it is a maintained inflammatory&#xD;
      disorder or a functional disorder, which differentiation is basic in order to indicate a&#xD;
      correct treatment of the patients. In addition, there is an information gap, unable to&#xD;
      respond if a patient with acute diverticulitis will have a high or low probability of&#xD;
      recurrence and at what time. There are still no studies answering these questions, key to&#xD;
      choosing the best treatment and to give an answer to the huge population of diverticulitis&#xD;
      patients.&#xD;
&#xD;
      HYPOTHESIS.&#xD;
&#xD;
        1. Establish a therapeutic algorithm in patients diagnosed with acute diverticulitis who go&#xD;
           to the emergency department, whose initial management is not an urgent surgical&#xD;
           intervention.&#xD;
&#xD;
        2. There is an inflammatory physiopathology underlying between acute episodes, which can&#xD;
           play a role in the apparition of the new episode of acute diverticulitis.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
        -  Description of prognostic factors of new episodes of acute diverticulitis which can be&#xD;
           easy detected in the outpatient clinic, and creation of a therapeutic algorithm that&#xD;
           allows selecting patients who could benefit from early surgery&#xD;
&#xD;
        -  Descriptive analysis of symptoms with Health Related Quality of Life questionnaires&#xD;
           (HRQL), in order to establish the evolution of the disease and correlate symptoms with&#xD;
           systemic and local inflammatory markers.&#xD;
&#xD;
        -  Sub-analysis of patients with immunosuppression to assess the virulence of the disease.&#xD;
&#xD;
      METHODOLOGY RECRUITMENT. All patients who meet the inclusion criteria, do not present any&#xD;
      exclusion criteria and voluntarily agree to participate in the study after having been&#xD;
      visited and diagnosed in the following hospitals will be included: Bellvitge University&#xD;
      Hospital (Barcelona), Vall d 'University Hospital Hebron (Barcelona), University Hospital del&#xD;
      Mar (Barcelona), Moises Broggi University Hospital (Barcelona), Joan XXIII University&#xD;
      Hospital (Tarragona), Parc Taulí University Hospital (Sabadell), Althaia Hospital (Manresa),&#xD;
      Josep Trueta University Hospital (Girona). All patients will receive an information sheet and&#xD;
      informed consent. Once the patients are considered eligible and have formulated their&#xD;
      questions and/or doubts to the investigator, they will be included.&#xD;
&#xD;
      STUDY GROUP (1): Patients with acute diverticulitis who come to the emergency department. It&#xD;
      will be taken in the emergency department Blood tests that include leukocyte count and&#xD;
      formula, C-reactive protein, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte&#xD;
      ratio, lymphocyte-monocyte ratio, Modified Glasgow Prognostic Score. Faecal calprotectin (the&#xD;
      collection tube that the patient must deliver after the first deposition will be delivered).&#xD;
&#xD;
      FOLLOW-UP:&#xD;
&#xD;
        1. all patients included in the study as DIVERTICULITIS GROUP, at the month of episode 3,&#xD;
           6, 12, 18 and 24 months of the first episode with Blood analysis with detection of&#xD;
           inflammatory systemic markers that will include leukocyte count, leukocyte formula,&#xD;
           Protein- C reactive. Neutrophil-Lymphocyte ratio, Platelet-lymphocyte ratio,&#xD;
           lymphocyte-monocyte ratio, Modified Glasgow Prognostic Score. Faecal calprotectin&#xD;
           Delivery to the patient of the stool sample collection kit. It will be delivered within&#xD;
           7 days, HRQL Questionnaires (SF-36) at 3, 6, 12, 18 and 24 months after the first&#xD;
           episode of acute diverticulitis. They will be delivered in the outpatient clinic.&#xD;
           Colonoscopy at 2 months after the first episode. It will be requested on the first&#xD;
           month's post-diverticulitis visit when the informed consent will be signed. In the&#xD;
           colonoscopy, the following will be analyzed: endoscopic description based on a&#xD;
           description of the endoscopic mucosa. Sampling and sending to the organizing centre of&#xD;
           the project (Bellvitge University Hospital): Sample A: 1-5cm of diverticulum that has&#xD;
           participated in diverticulitis episode Sample B: 30cm of the area that has suffered&#xD;
           diverticulitis. Rome VI criteria at 3 months follow-up. Sampling for the study of local&#xD;
           inflammatory markers: IL-6, IL-10, tumour necrosis factor (TNF), macrophages,&#xD;
           calculation of inflammation index of Ulcerative Colitis. All data will be collected in&#xD;
           the workbook-CRD website.&#xD;
&#xD;
        2. DIVERTICULOSIS GROUP AND CONTROL GROUP: Patients with asymptomatic diverticula and&#xD;
           patients without diverticula. DIVERTICULOSIS GROUP. Samples will be collected from&#xD;
           patients undergoing colonoscopy for another reason (polyp control) and diagnosed with&#xD;
           diverticulosis, without having presented an episode of recent diverticulitis.&#xD;
&#xD;
      Only patients from the organizing centre (Bellvitge University Hospital) will be included.&#xD;
&#xD;
      CONTROL GROUP. Patients who undergo colonoscopy for another reason (polyps control) and no&#xD;
      diverticulosis is found. Only patients from the organizing centre (Bellvitge University&#xD;
      Hospital) will be included. Test to take: A blood test that will include leukocyte count and&#xD;
      leukocyte formula, C-reactive protein. Neutrophil-Lymphocyte ratio], Platelet-lymphocyte&#xD;
      ratio, lymphocyte-monocyte ratio, Modified Glasgow Prognostic Score. Faecal calprotectin&#xD;
      (LOOK ANNEX-protocol for collection and storage of stool sample). Colonoscopy with sample for&#xD;
      the study of local inflammatory markers: IL-6, IL10, tumour necrosis factor (TNF), local&#xD;
      macrophages: Endoscopic description based on a description of the mucosa Endoscopic Sampling:&#xD;
      Sample A: 1-5cm from any diverticulum, if any (diverticulosis group). In case there are no&#xD;
      diverticula, 2 random samples, Sample B: 30 cm from the diverticulosis area if any. In case&#xD;
      there are no diverticula, 2 random samples. Collection of results in the workbook-CRD&#xD;
      website.&#xD;
&#xD;
      DESCRIPTIVE VARIABLES OF THE POPULATION: -Numerical variable of identification of the case&#xD;
      -Age-Sex -Previous episodes of acute diverticulitis- Date of the episodes -Consumption of&#xD;
      alcohol- Tobacco consumption- exercise.&#xD;
&#xD;
      MAIN VARIABLE. Local and systemic inflammatory markers. Calprotectin.&#xD;
&#xD;
      SECONDARY VARIABLES: Colonoscopy markers -Quality of life questionnaire SF-12/GIQLI -&#xD;
      immunosuppression.&#xD;
&#xD;
      SCHEDULE:&#xD;
&#xD;
        -  1)Patient recruitment period: 1 year&#xD;
&#xD;
        -  2)Follow-up of patients: 2 years from the date of the first episode&#xD;
&#xD;
        -  3)Data entry: parallel to the follow-up of patients in the workbooks-CRD website.&#xD;
&#xD;
        -  4)Debugging and data analysis: parallel to the follow-up of patients.&#xD;
&#xD;
        -  5)External monitoring and auditing of the centres one year after the start of data&#xD;
           collection, midway through the study and at the end of inclusion.&#xD;
&#xD;
        -  6)Preparation of articles for the publication of the results: 1 year after the process&#xD;
           of collection and statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">May 25, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 25, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Recurrence of acute diverticulitis</measure>
    <time_frame>2 years</time_frame>
    <description>To detect which patients with acute diverticulitis recur</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic inflammatory markers</measure>
    <time_frame>2 years</time_frame>
    <description>To correlate systemic inflammatory markers with acute diverticulitis recurrence.&#xD;
* Systemic inflammatory markers include: A blood test with leukocyte count and formula, C-reactive protein, albumin, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte ratio calculation, lymphocyte-monocyte ratio calculatio, Modified Glasgow Prognostic score calculation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Faecal calprotectine</measure>
    <time_frame>2 years</time_frame>
    <description>To correlate faecal calprotectine with acute diverticulitis recurrence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local inflammatory markers</measure>
    <time_frame>2 years</time_frame>
    <description>To correlate local inflammatory markers with systemic inflammatory markers and recurrence.&#xD;
*Local inflammatory markers come from colonic endoscopic samples taken in the colonoscopy at 2 months after the acute diverticulitis episode. 2 samples are taken:&#xD;
Sample A: 1-5cm of diverticulum that has participated in diverticulitis episode (correlated with the CT)&#xD;
Sample B: 30cm of the area that has suffered diverticulitis. Sampling for the study of local inflammatory markers includes IL-6, IL-10, tumour necrosis factor (TNF), macrophages, eosinophils and calculation of inflammation index of Ulcerative Colitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HRQL (Health Related Quality of Life) QUESTIONNAIRES</measure>
    <time_frame>2 years</time_frame>
    <description>To correlate clinical symptoms with inflammatory markers.&#xD;
Questionnaires used:&#xD;
SF-12 Health Survey, in order to measure Mental and Physical Health. There are 8 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state)&#xD;
GIQLI (Gastrointestinal Quality of Life questionnaire). Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Acute Diverticulitis</condition>
  <arm_group>
    <arm_group_label>Diverticulitis Group</arm_group_label>
    <description>Patients with acute diverticulitis episode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diverticulosis group</arm_group_label>
    <description>Patients diagnosed with diverticulosis without any acute diverticulitis episode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-diverticulosis</arm_group_label>
    <description>Patients without diverticulosis</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Faecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        DIVERTICULITIS COHORT: Patients with current acute diverticulitis, diagnosed with abdominal&#xD;
        CT and not requiring urgent surgery for this reason&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18years&#xD;
&#xD;
          -  Current episode of acute diverticulitis diagnosed with abdominal CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rejection of the patient&#xD;
&#xD;
          -  Severe diverticulitis requiring urgent surgery&#xD;
&#xD;
          -  Inability to understand HRQL questionnaires&#xD;
&#xD;
          -  IBD background&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Acute diverticulitis episodes within the prior year to the start of the study&#xD;
&#xD;
          -  Patients who meet Roma IV criteria for IBS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marta C Climent</last_name>
    <phone>+34655321809</phone>
    <email>martacliment@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitari Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta C Climent</last_name>
      <phone>655321809</phone>
      <email>martacliment@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Sebastiano Biondo</investigator_full_name>
    <investigator_title>Sebastiano Biondo. Clinical Professor. Head of Surgery Department</investigator_title>
  </responsible_party>
  <keyword>Acute diverticulitis</keyword>
  <keyword>Chronic diverticulitis</keyword>
  <keyword>Recurrence</keyword>
  <keyword>Diverticulitis treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diverticulitis</mesh_term>
    <mesh_term>Diverticulitis, Colonic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04407793
org study id: DICRO-2020
nct id: NCT04407793
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
MAIN OBJECTIVE: Description of predicted markers of acute diverticulitis crisis, using
      bivariate and multivariate analyses. Analysis of acute diverticulitis predictor swings.

      SIDE OBJECTIVES: Descriptive analysis of HRQL in the different measurement periods to
      establish the evolution of the disease. Correlate HRQL values of systemic and local
      inflammatory markers in the diverticulitis group. Sub-analysis of patients with
      immunosuppression to evaluate disease virulence compared to a group of patients without
      immunosuppression.

      STUDY TYPE: Clinical, observational, prospective and multicenter study (8 hospitals) with
      three study groups: patients diagnosed with acute diverticulitis attending emergencies,
      diverticulosis patients and patients without diverticulums. INCLUSION CRITERIA: Age > 18years
      and radiological diagnosis by abdominal CT acute diverticulitis. EXCLUSION CRITERIA:
      Rejection of the patient -severe diverticulitis requiring urgent surgery -an inability to
      understand HRQL questionnaire - IBD - pregnancy or breastfeeding - acute diverticulitis
      within the prior year of the study - Roma IV criteria fulfilment. VARIABLES: Main variables:
      local and systemic inflammatory markers- faecal calprotectin. Secondary variables: recurrence
      of acute diverticulitis -the persistence of symptoms - SF 12 and GIQLI questionnaires.

      STATISTICS: Sample size: alpha error 0.05; beta error 0.20; bilateral; proportion 0.9 in the
      control group; 500 subjects group diverticulitis, 200 group diverticulosis and not
      diverticulums.
GENERAL CHARACTERISTICS OF THE PROJECT:

      Despite being a benign pathology, colon diverticulitis represents the fifth most important
      gastrointestinal pathology and has a great clinical impact on the quality of life of patients
      and on health expenditure. Understanding a disease involves being able to make the correct
      diagnosis of the patient and most importantly for the patient, an adequate treatment of his
      symptoms. It is required to give accurate information to the patient and answer his doubts,
      although the pathophysiology of the disease is unknown. As it is a benign disease with
      heterogeneous behaviours and manifestations, it is difficult to make the decision related to
      undergo surgery. This decision could be facilitated if it is based on extensive information
      from the doctor. It is also important to be able to select those patients who have a higher
      risk of relapse in order to prioritize them on the waiting list for surgery. As a benign
      disease with occupational active patient involvement, acute diverticulitis has a major
      economic impact by leading to repeat leaves in some patients, who are even on a waiting list
      to operate.

      EXPECTED IMPACT:

      We believe that this project can respond to the management of a group of patients, in which
      there is currently no consensus in the Scientific Community. Therefore, our results are
      transferable, as we intend to establish the pathophysiology of the entity known as chronic
      diverticulitis and detect the predictors of that entity. Currently, there is no consensus on
      the therapeutic management of patients with recurrent episodes of diverticulitis or
      persistent symptoms, so that they are treated differently at the discretion of the surgeon,
      without any scientific basis. It is also unclear whether it is a maintained inflammatory
      disorder or a functional disorder, which differentiation is basic in order to indicate a
      correct treatment of the patients. In addition, there is an information gap, unable to
      respond if a patient with acute diverticulitis will have a high or low probability of
      recurrence and at what time. There are still no studies answering these questions, key to
      choosing the best treatment and to give an answer to the huge population of diverticulitis
      patients.

      HYPOTHESIS.

        1. Establish a therapeutic algorithm in patients diagnosed with acute diverticulitis who go
           to the emergency department, whose initial management is not an urgent surgical
           intervention.

        2. There is an inflammatory physiopathology underlying between acute episodes, which can
           play a role in the apparition of the new episode of acute diverticulitis.

      OBJECTIVES:

        -  Description of prognostic factors of new episodes of acute diverticulitis which can be
           easy detected in the outpatient clinic, and creation of a therapeutic algorithm that
           allows selecting patients who could benefit from early surgery

        -  Descriptive analysis of symptoms with Health Related Quality of Life questionnaires
           (HRQL), in order to establish the evolution of the disease and correlate symptoms with
           systemic and local inflammatory markers.

        -  Sub-analysis of patients with immunosuppression to assess the virulence of the disease.

      METHODOLOGY RECRUITMENT. All patients who meet the inclusion criteria, do not present any
      exclusion criteria and voluntarily agree to participate in the study after having been
      visited and diagnosed in the following hospitals will be included: Bellvitge University
      Hospital (Barcelona), Vall d 'University Hospital Hebron (Barcelona), University Hospital del
      Mar (Barcelona), Moises Broggi University Hospital (Barcelona), Joan XXIII University
      Hospital (Tarragona), Parc Taulí University Hospital (Sabadell), Althaia Hospital (Manresa),
      Josep Trueta University Hospital (Girona). All patients will receive an information sheet and
      informed consent. Once the patients are considered eligible and have formulated their
      questions and/or doubts to the investigator, they will be included.

      STUDY GROUP (1): Patients with acute diverticulitis who come to the emergency department. It
      will be taken in the emergency department Blood tests that include leukocyte count and
      formula, C-reactive protein, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte
      ratio, lymphocyte-monocyte ratio, Modified Glasgow Prognostic Score. Faecal calprotectin (the
      collection tube that the patient must deliver after the first deposition will be delivered).

      FOLLOW-UP:

        1. all patients included in the study as DIVERTICULITIS GROUP, at the month of episode 3,
           6, 12, 18 and 24 months of the first episode with Blood analysis with detection of
           inflammatory systemic markers that will include leukocyte count, leukocyte formula,
           Protein- C reactive. Neutrophil-Lymphocyte ratio, Platelet-lymphocyte ratio,
           lymphocyte-monocyte ratio, Modified Glasgow Prognostic Score. Faecal calprotectin
           Delivery to the patient of the stool sample collection kit. It will be delivered within
           7 days, HRQL Questionnaires (SF-36) at 3, 6, 12, 18 and 24 months after the first
           episode of acute diverticulitis. They will be delivered in the outpatient clinic.
           Colonoscopy at 2 months after the first episode. It will be requested on the first
           month's post-diverticulitis visit when the informed consent will be signed. In the
           colonoscopy, the following will be analyzed: endoscopic description based on a
           description of the endoscopic mucosa. Sampling and sending to the organizing centre of
           the project (Bellvitge University Hospital): Sample A: 1-5cm of diverticulum that has
           participated in diverticulitis episode Sample B: 30cm of the area that has suffered
           diverticulitis. Rome VI criteria at 3 months follow-up. Sampling for the study of local
           inflammatory markers: IL-6, IL-10, tumour necrosis factor (TNF), macrophages,
           calculation of inflammation index of Ulcerative Colitis. All data will be collected in
           the workbook-CRD website.

        2. DIVERTICULOSIS GROUP AND CONTROL GROUP: Patients with asymptomatic diverticula and
           patients without diverticula. DIVERTICULOSIS GROUP. Samples will be collected from
           patients undergoing colonoscopy for another reason (polyp control) and diagnosed with
           diverticulosis, without having presented an episode of recent diverticulitis.

      Only patients from the organizing centre (Bellvitge University Hospital) will be included.

      CONTROL GROUP. Patients who undergo colonoscopy for another reason (polyps control) and no
      diverticulosis is found. Only patients from the organizing centre (Bellvitge University
      Hospital) will be included. Test to take: A blood test that will include leukocyte count and
      leukocyte formula, C-reactive protein. Neutrophil-Lymphocyte ratio], Platelet-lymphocyte
      ratio, lymphocyte-monocyte ratio, Modified Glasgow Prognostic Score. Faecal calprotectin
      (LOOK ANNEX-protocol for collection and storage of stool sample). Colonoscopy with sample for
      the study of local inflammatory markers: IL-6, IL10, tumour necrosis factor (TNF), local
      macrophages: Endoscopic description based on a description of the mucosa Endoscopic Sampling:
      Sample A: 1-5cm from any diverticulum, if any (diverticulosis group). In case there are no
      diverticula, 2 random samples, Sample B: 30 cm from the diverticulosis area if any. In case
      there are no diverticula, 2 random samples. Collection of results in the workbook-CRD
      website.

      DESCRIPTIVE VARIABLES OF THE POPULATION: -Numerical variable of identification of the case
      -Age-Sex -Previous episodes of acute diverticulitis- Date of the episodes -Consumption of
      alcohol- Tobacco consumption- exercise.

      MAIN VARIABLE. Local and systemic inflammatory markers. Calprotectin.

      SECONDARY VARIABLES: Colonoscopy markers -Quality of life questionnaire SF-12/GIQLI -
      immunosuppression.

      SCHEDULE:

        -  1)Patient recruitment period: 1 year

        -  2)Follow-up of patients: 2 years from the date of the first episode

        -  3)Data entry: parallel to the follow-up of patients in the workbooks-CRD website.

        -  4)Debugging and data analysis: parallel to the follow-up of patients.

        -  5)External monitoring and auditing of the centres one year after the start of data
           collection, midway through the study and at the end of inclusion.

        -  6)Preparation of articles for the publication of the results: 1 year after the process
           of collection and statistical analysis.
observational model: Cohort
time perspective: Prospective
measure: Recurrence of acute diverticulitis
time frame: 2 years
description: To detect which patients with acute diverticulitis recur
measure: Systemic inflammatory markers
time frame: 2 years
description: To correlate systemic inflammatory markers with acute diverticulitis recurrence.
* Systemic inflammatory markers include: A blood test with leukocyte count and formula, C-reactive protein, albumin, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte ratio calculation, lymphocyte-monocyte ratio calculatio, Modified Glasgow Prognostic score calculation.
measure: Faecal calprotectine
time frame: 2 years
description: To correlate faecal calprotectine with acute diverticulitis recurrence
measure: Local inflammatory markers
time frame: 2 years
description: To correlate local inflammatory markers with systemic inflammatory markers and recurrence.
*Local inflammatory markers come from colonic endoscopic samples taken in the colonoscopy at 2 months after the acute diverticulitis episode. 2 samples are taken:
Sample A: 1-5cm of diverticulum that has participated in diverticulitis episode (correlated with the CT)
Sample B: 30cm of the area that has suffered diverticulitis. Sampling for the study of local inflammatory markers includes IL-6, IL-10, tumour necrosis factor (TNF), macrophages, eosinophils and calculation of inflammation index of Ulcerative Colitis.
measure: HRQL (Health Related Quality of Life) QUESTIONNAIRES
time frame: 2 years
description: To correlate clinical symptoms with inflammatory markers.
Questionnaires used:
SF-12 Health Survey, in order to measure Mental and Physical Health. There are 8 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state)
GIQLI (Gastrointestinal Quality of Life questionnaire). Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)
arm group label: Diverticulitis Group
description: Patients with acute diverticulitis episode
arm group label: Diverticulosis group
description: Patients diagnosed with diverticulosis without any acute diverticulitis episode
arm group label: Non-diverticulosis
description: Patients without diverticulosis
Faecal samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marta C Climent
phone: +34655321809
email: martacliment@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Sebastiano Biondo
investigator title: Sebastiano Biondo. Clinical Professor. Head of Surgery Department
mesh term: Diverticulitis
mesh term: Diverticulitis, Colonic