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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele Roma

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 years or older

Diagnosis of acute complicated diverticulitis requiring non-elective operative management

Emergency or urgent surgery for complicated diverticulitis, including surgery after failure of non-operative management

Minimally invasive approach: laparoscopic/robotic surgery

Disqualifiers

Age younger than 18 years

Elective surgery for diverticular disease

Uncomplicated diverticulitis managed non-operatively

Surgery performed for conditions not related to diverticulitis

Trial design

Treatments tested in this trial

  • Primary anastomosis
  • Hartmann's procedure

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators