The COLD2B Multicenter, Two-arm Prospective Cohort Study (NCT06388538) | Clinical Trial Compass
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The COLD2B Multicenter, Two-arm Prospective Cohort Study
Italy500 participantsStarted 2024-06-01
Plain-language summary
Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, the COLD2B study has been launched to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.
The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).
Moreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).
The second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients of both sexes, ≥ 18 years old.
✓. Patients with abdominal CT scan diagnosis of colonic Acute Diverticulitis classifiable as WSES 2B, i.e..
✓. thickening and other phlegmon signs of the left-sided colonic wall (mostly sigmoid) associated with the inflammatory involvement of the surrounding tissues, plus
✓. presence of air bubbles distant more than 5 cm from the primary colonic inflammatory localization, plus
✓. absence of conspicuous free fluid collection or pelvic abscess.
✓. Patients fit for surgery.
✓. Patients with colonic diverticulitis on postoperative histological examination.
Exclusion criteria
✕. Right-sided or transverse diverticulitis
✕. Concomitant bowel abscess, perforation, or fistula