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NCT07651072
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Conditions: Complicated Diverticulitis, Acute Diverticulitis, Peritonitis, Perforated Diverticulitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: IRCCS San Raffaele Roma
Location: ASL Romagna Cesena FC
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07651072). StuddyBuddy aggregates publicly available trial information.