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Management and Evolution of Acute Diverticulitis With Pericolic Free Gas

NCT04311385 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-06-08

No results posted yet for this study

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.

Conditions

  • Diverticulitis
  • Diverticulitis Colon
  • Diverticulitis; Perforation, Bowel
  • Diverticulitis of Sigmoid

Interventions

DIAGNOSTIC_TEST

CT imaging

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

Sponsors & Collaborators

  • Hospital Central de la Defensa Gómez Ulla

    lead OTHER

Principal Investigators

  • Patricia Tejedor, Consultant · Hospital Central de la Defensa Gómez Ulla

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311385 on ClinicalTrials.gov