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Management and Evolution of Acute Diverticulitis With Pericolic Free Gas (ADiFas)

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ClinicalTrials.gov Identifier: NCT04311385
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Patricia Tejedor, Hospital Central de la Defensa Gómez Ulla

Brief Summary:

The severity of diverticulitis is usually graded with the use of modified Hinchey Criteria. However, there is a condition often seen in the CT scan that is not included in this classification itself; 1-2 pericolic bubbles but no free air or fluid into the abdomen or above the liver. Outcome in these patients remains unknown. We aim to analyse the treatment that these patients and their evolution over the first year after the diagnosis in order to predict the disease related outcome.

The study is set up as a retrospective multicentre observational study. Inclusion criteria are Patients over 18 years old, Diagnosed of acute diverticulitis with a CT scan reported as 1-2 pericolic bubbles with or without free fluid. Exclusion criteria: 1) CT scan showing free distant bubbles in the abdomen. 2) CT scan showing abscess.

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 137 subjects are necessary in the observed group to recognize a difference in morbidity greater than or equal to 10%. A proportion in the reference group has been estimated to be 20%. It has been anticipated a drop-out rate of 0%.

Primary outcome is 30-day morbidity and mortality. Secondary outcomes include malignancy and 1 year morbidity including recurrences and ongoing disease. Data will be collected in an online repository. The CT scans will be reviewed by 2 experienced independent radiologists. The management of these patients at the moment of the diagnosis will be recorded, as well as their evolution over the first year during the outpatient clinics. Figure 1 represents the study flow chart.

Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (01/06/2020 - 31/12/2021).

CT scans will be reviewed by 2 experienced radiologists. Every other CT scan performed during the follow-up will be reviewed by the same radiologists.

The management of these patients at the moment of the diagnosis will be recorded, as well as their evolution over the first year during the outpatient clinics.

This study protocol is a new approach to an unknown entity in diverticulitis. We are convince that the outcomes are clinically relevant to patients and interesting for all physicians treating diverticulitis.


Condition or disease Intervention/treatment
Diverticulitis Diverticulitis Colon Diverticulitis; Perforation, Bowel Diverticulitis of Sigmoid Diagnostic Test: CT imaging

Detailed Description:

Diverticular disease of the colon is a common disease that includes diverticulosis and diverticulitis. Most patients who have diverticulosis remain asymptomatic; however an estimated 15-20% will develop acute diverticulitis (AD).(1) AD is an inflammatory condition affecting at least one colonic diverticula, often associated with pericolonic inflammation.(2) Diverticulitis can range form mild to severe. Severe, complicated cases with perforation may be associated with intra-abdominal abscess, generalized, purulent peritonitis, fistula formation, bleeding or obstruction. The extent of the perforation determines the clinical behavior. Microperforations remain localised because they are contained by pericolic fat and mesentery, leading to the formation of small pericolic abscesses.

The gold standard for the diagnosis of diverticulitis is the Computed Tomography (CT). It has a sensitivity ranging form 85% to 97% (3,4) and it is very accurate identifying colonic perforation, which can have a direct impact on the management of the patient. The severity of diverticulitis is usually graded with the use of modified Hinchey's Criteria, based on CT imaging and on preoperative findings.(5) It distinguishes four stages of acute complicated diverticulitis. Several modifications to the Hinchey classification have been proposed due to the advancements in imaging modalities. New subcategories have been added that take radiological findings into consideration.(6) However, there is a condition often seen in the CT scan that is not included in this classification itself; a single pericolic bubble.

The management of AD depends on its severity and complexity, and it requires hospitalization, bowel rest and surgery in selected cases. Antibiotic therapy is part of the management of complicated diverticulitis and recent guidelines are in accordance at recommending broad-spectrum antibiotics. Biondo and colleagues evaluated 92 papers in a systematic review, concluding that patients with severe AD without need of emergency surgery, should be treated with hospitalization, parenteral fluids and a single intravenous antibiotic active against aerobic and anaerobic bacteria.(7) Approximately 15-20% of patients admitted with AD have an abscess on CT scan.(8) The size of 3-6 cm has been generally accepted to be treated with antibiotics vs. percutaneous drainage.(8-10) However, clinical monitoring is mandatory and a CT scan should be repeated if the patient does not show clinical and laboratory improvement.

In the 1990s laparoscopic lavage (LL) was proposed to treat patients affected by peritonitis due to perforated AD.(11) Initial results encouraged surgeons to perform LL;(12-14) however, in the 2000s three Randomized Control Trials (RCT) were published with mixed results.(15-17) Two of them suggested that the traditional surgical treatment (segmental resection and stoma formation) achieves more successful results.(16,17) In summary, there are several guidelines for the treatment of AD regarding its severity; however, there is no consensus in the management of those patients with 1-2 pericolic bubbles but no free air into the abdomen. The treatment that these patients receive is widely variable.

For this reason, patients admitted in the emergency unit and diagnosed of acute diverticulitis with a free pericolic bubble of air, regardless the Hinchey's criteria assigned and the treatment received, would be included in this study. We aim to analyse the treatment that they underwent and the evolution of these patients over the first year after the diagnosis. The patients will not undergo any treatment or test that would not be necessary during their follow-up out of this observational and retrospective study.

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Study Type : Observational
Estimated Enrollment : 137 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Management and Evolution of Acute Diverticulitis With Pericolic Free Gas - a Multicentre Observational Study
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Diverticulitis

Patients admitted as an emergency with acute diverticulitis diagnosed by CT scan.

Inclusion criteria

  • Patients over 18 years old
  • Informed consent form signed
  • Diagnosed of acute diverticulitis
  • CT scan reported as 1-2 pericolic bubbles with or without free fluid

Exclusion criteria

o CT scan showing free distant bubbles in the abdomen

Diagnostic Test: CT imaging
CT scan reported as 1-2 pericolic bubbles, but no free distant bubbles in the abdomen or abscess.




Primary Outcome Measures :
  1. 30-day morbidity [ Time Frame: 30 days ]
    • Diverticulitis recurrence
    • Perforation (with purulent/fecal peritonitis)
    • Fistula
    • Symptomatic colonic stenosis
    • Intraabdominal abcess
    • Stoma formation
    • Emergency surgery or re-operation
    • Peri- and postoperative complications (Dindo-Clavien classification)


Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    Death within 30 days

  2. Malignancy [ Time Frame: 60 days ]
    Malignancy in the pathological report in cases undergoing surgery

  3. 1-year morbidity [ Time Frame: 1 year ]
    • Diverticulitis recurrence
    • Perforation (with purulent/fecal peritonitis)
    • Fistula
    • Symptomatic colonic stenosis
    • Intraabdominal abcess
    • Stoma formation
    • Emergency surgery or re-operation
    • Peri- and postoperative complications (Dindo-Clavien classification)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Emergency unit Hospitalization
Criteria

Inclusion Criteria:

  • Patients over 18 years old
  • Informed consent
  • Diagnosed of acute diverticulitis
  • CT scan reported as 1-2 pericolic bubbles with or without free fluid.

Exclusion Criteria:

  • CT scan showing free distant bubbles in the abdomen
  • CT scan showing abscess

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311385


Contacts
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Contact: Patricia Tejedor, Consultant 0034914222000 patricia.tejedor@hotmail.com

Locations
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Spain
Hospital Central de la Defensa Gómez Ulla Recruiting
Madrid, Spain, 28047
Contact: Patricia Tejedor, Consultant       patricia.tejedor@hotmail.com   
Principal Investigator: Patricia Tejedor, Consultant         
Sub-Investigator: Marguerite Gorter-Stam, Consultant         
Sponsors and Collaborators
Hospital Central de la Defensa Gómez Ulla
Investigators
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Principal Investigator: Patricia Tejedor, Consultant Hospital Central de la Defensa Gómez Ulla
Publications of Results:

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Responsible Party: Patricia Tejedor, Colorectal Consultant Surgeon, Hospital Central de la Defensa Gómez Ulla
ClinicalTrials.gov Identifier: NCT04311385    
Other Study ID Numbers: 8_20
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Tejedor, Hospital Central de la Defensa Gómez Ulla:
Acute diverticulitis
Hinchey
Management of diverticulitis
Treatment of diverticulitis
Diverticulitis classification
Additional relevant MeSH terms:
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Diverticulitis
Diverticulitis, Colonic
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases