Clinical Trial

AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis

Study acronym: AIDE/OBS/2025
Not Yet Recruiting
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Summary
The AIDE/OBS study is a multicenter, observational, non-interventional study designed to collect standardized clinical, radiological, intraoperative visual, and surgical reasoning data from adult patients undergoing non-elective surgery for complicated acute diverticulitis. The study focuses on patients requiring urgent or emergency operative management, including cases following failure of non-operative management. The main intraoperative decision of interest is the choice between sigmoid resection with primary anastomosis, with or without diverting stoma, and Hartmann's procedure. The current phase aims to build a structured multimodal dataset and to validate and refine a preliminary expert-informed decision-support tool. The study does not modify standard clinical practice, surgical indication, operative strategy, or postoperative management. All treatment decisions remain at the discretion of the treating surgical team according to local practice.
Trial Details
NCT Number NCT07651072
Lead Sponsor IRCCS San Raffaele Roma
Conditions Complicated Diverticulitis, Acute Diverticulitis, Peritonitis, Perforated Diverticulitis
Enrollment 150 participants
Start Date 2026-05-31
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-16