The COLD2B Multicenter, Two-arm Prospective Cohort Study

Launched by AZIENDA SANITARIA DI FIRENZE · Apr 24, 2024

Keywords

ClinConnect Summary

The COLD2B study is a clinical trial designed to help doctors understand the best way to treat patients with a specific type of acute diverticulitis, known as WSES 2B. This condition involves inflammation of the colon, which can lead to serious complications. The study will compare two treatment options: a conservative approach (using medications and monitoring) and a surgical approach (either open surgery or minimally invasive surgery). The main goal is to find out which method leads to shorter hospital stays and to assess any risks involved, such as complications or mortality.

To participate in this trial, you need to be at least 18 years old and diagnosed with WSES 2B acute diverticulitis through a CT scan. You should be in good enough health to consider surgery if needed, and the condition must be confirmed through a tissue examination after surgery. Unfortunately, if you have certain other conditions, like a different type of diverticulitis or complications like a bowel abscess, you won’t be eligible. If you join the study, you can expect to be closely monitored throughout your treatment, and your experiences will contribute to important findings that could improve care for future patients with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients of both sexes, ≥ 18 years old.
• • 2. Patients with abdominal CT scan diagnosis of colonic Acute Diverticulitis classifiable as WSES 2B, i.e..
• • 1. thickening and other phlegmon signs of the left-sided colonic wall (mostly sigmoid) associated with the inflammatory involvement of the surrounding tissues, plus
• • 2. presence of air bubbles distant more than 5 cm from the primary colonic inflammatory localization, plus
• • 3. absence of conspicuous free fluid collection or pelvic abscess.
• • 3. Patients fit for surgery.
• • 4. Patients with colonic diverticulitis on postoperative histological examination.
• Exclusion Criteria:
• • 1. Right-sided or transverse diverticulitis
• • 2. Concomitant bowel abscess, perforation, or fistula
• • 3. Radiological drainage
• • 4. Elective procedures.
• • 5. Pregnancy or lactation
• • 6. Patients of both sexes, younger than 18 years of age