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NOT YET RECRUITING
NCT07651072

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

Sponsor: IRCCS San Raffaele Roma

View on ClinicalTrials.gov

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.

Official title: AIDE: a Multicenter Observational Study to Support the Decision Between Anastomosis and Colostomy in Emergency Surgery for Complicated Acute Diverticulitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-05-31

Completion Date

2028-04-30

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

PROCEDURE

Primary anastomosis

Observed surgical strategy consisting of sigmoid resection with colorectal anastomosis, with or without diverting stoma, performed according to standard clinical practice. The study does not assign this procedure.

PROCEDURE

Hartmann's procedure

Observed surgical strategy consisting of sigmoid resection with end colostomy and rectal stump closure, performed according to standard clinical practice. The study does not assign this procedure.

Locations (1)

ASL Romagna

Cesena, FC, Italy