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.
Complicated acute diverticulitis requiring non-elective surgery remains a challenging condition in emergency colorectal surgery. In patients with diffuse peritonitis or severe complicated disease, the intraoperative decision between primary anastomosis and Hartmann's procedure is complex and influenced by patient-related factors, disease severity, contamination, tissue quality, bowel perfusion, technical feasibility, and surgeon judgment. The AIDE/OBS study aims to collect retrospectively and prospectively standardized real-world data from multiple centers to better understand the factors influencing this decision. The study will collect clinical and demographic characteristics, comorbidities, radiological findings including WSES CT-driven classification, intraoperative findings, operative strategy, postoperative outcomes, anonymized intraoperative images or videos when available, and surgeon-reported decision-making factors. The collected data will be used to validate and refine a preliminary expert-informed AI-based decision-support framework. The long-term objective is to support the development of future artificial intelligence and computer vision tools that may assist emergency surgeons during intraoperative decision-making in complicated diverticulitis. This is an observational, non-interventional study. No experimental treatment, device, or AI-guided recommendation is applied to patients during the study. Surgical management is performed according to standard clinical practice and local protocols.
Study Type
OBSERVATIONAL
Enrollment
150
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.
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.
ASL Romagna
Cesena, FC, Italy
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Structured analysis of patient-related, disease-related, imaging-related, intraoperative, and surgeon-reported factors influencing the choice between primary anastomosis and Hartmann's procedure in non-elective surgery for complicated diverticulitis.
Time frame: Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.
Rate of primary anastomosis versus Hartmann's procedure
Proportion of patients undergoing primary anastomosis, with or without diverting stoma, compared with Hartmann's procedure.
Time frame: Assessed intraoperatively during the index emergency surgical procedure.
Completeness of standardized intraoperative visual data acquisition
Proportion of cases with uploaded anonymized intraoperative images or videos according to the predefined study phases.
Time frame: From the start of the index emergency surgical procedure until completion of intraoperative image or video acquisition, assessed up to the end of the operation.
Anastomotic leak rate
Rate of clinically or radiologically diagnosed anastomotic leak among patients receiving primary anastomosis.
Time frame: From the date of surgery until 30 postoperative days.
Postoperative morbidity
Rate of postoperative complications after non-elective surgery for complicated diverticulitis.
Time frame: Assessed during index hospitalization and up to 30 postoperative days.
Stoma creation rate
Proportion of patients receiving a stoma during the index operation.
Time frame: Assessed intraoperatively during the index emergency surgical procedure.
Length of hospital stay
Duration of hospital stay after the index operation.
Time frame: From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.
Mortality
All-cause postoperative mortality
Time frame: From the date of surgery up to 30 postoperative days.
Proportion of enrolled cases with complete standardized clinical and intraoperative visual datasets
Feasibility will be assessed as the proportion of enrolled patients for whom the participating center successfully submits a complete standardized dataset, including required clinical variables, radiological classification, intraoperative decision-making form, and standardized intraoperative visual material according to the study protocol. A complete visual dataset will be defined as submission of the required intraoperative images or video frames for the predefined operative phases, when technically feasible.
Time frame: From study initiation until completion of participant enrollment and database closure, estimated up to 24 months.
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