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

Starting soon

Conditions studied: Complicated Diverticulitis, Acute Diverticulitis, Peritonitis, Perforated Diverticulitis

In brief

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.

Key facts

Study ID

NCT07651072

Run by

IRCCS San Raffaele Roma

People needed

150

Starts

2026-05-31

Expected to finish

2028-04-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients undergoing sigmoid resection with primary anastomosis, Hartmann's procedure, or other operative strategy according to local practice
• Availability of clinical and operative data
• Local ethical approval, authorization, or waiver according to national and institutional regulations

You may not qualify if…

• Age younger than 18 years
• Elective surgery for diverticular disease
• Uncomplicated diverticulitis managed non-operatively
• Surgery performed for conditions not related to diverticulitis
• Surgical procedures performed via primary open approach (i.e., no attempt at minimally invasive surgery), unless converted intraoperatively.
• Lack of required consent or authorization for data use, when required by local regulations

Where it is running

• ASL Romagna — Cesena, FC, Italy

Full record on ClinicalTrials.gov

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