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Clinical Trials/NL-OMON27328
NL-OMON27328
Not yet recruiting
Not Applicable

A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis.

Academic Medical Center, department of Surgery0 sites534 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diverticulitis, antibiotics, observation
Sponsor
Academic Medical Center, department of Surgery
Enrollment
534
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

/A

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Academic Medical Center, department of Surgery

Eligibility Criteria

Inclusion Criteria

  • 1\. Only left\-sided uncomplicated (mild) acute diverticulitis;
  • 2\. Clinical suspicion of acute diverticulitis. For acute diagnostic work\-up: ultrasound or CT proven diverticulitis. In the case of diverticulitis\-negative ultrasound in clinically suspected patients an intravenous contrast\-enhanced CT scan is mandatory for confirmation of diverticulitis or exclusion of other pathology. CT for Hinchey/Ambrosetti classification (which is a CT\-based classification system) is needed for all patients, but can be delayed 1 day in those with ultrasound diagnosis. Staging diverticultis is defined according the modified Hinchey/Ambrosetti staging, only stages 1a and 1b and mild diverticulitis (1a Confined pericoloc inflammation, 1b Confined small (smaller than 5cm) pericolic abscess) are included. In the attachments we have added a flow chart, showing systematically the inclusion criteria and the following steps after inclusion;

Exclusion Criteria

  • 1\. Previous radiological (ultrasound and/or CT) proven episode of diverticulitis;
  • 2\. Colonic cancer;

Outcomes

Primary Outcomes

Not specified

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