An observational study in Complicated Diverticulitis, Acute Diverticulitis and Peritonitis, sponsored by IRCCS San Raffaele Roma. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by IRCCS San Raffaele Roma · Observational
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 150 is close to the median of 137 across 55 observational studies indexed under Peritonitis.
Browse Peritonitis studies →IRCCS San Raffaele Roma is the lead sponsor of 71 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing non-elective surgery for acute complicated diverticulitis at participating centers. Eligible patients include those requiring emergency or urgent operative management, including cases after failure of non-operative treatment, according to local clinical practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients undergoing sigmoid resection with primary anastomosis, with or without diverting stoma, for complicated acute diverticulitis in a non-elective surgical setting.
Procedure: Primary anastomosis
Patients undergoing sigmoid resection with end colostomy and rectal stump closure for complicated acute diverticulitis in a non-elective surgical setting.
Procedure: Hartmann's procedure
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.
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.
Plan to share: Undecided
Started May 2026 (actual). Primary completion is estimated for Dec 2029, 43 months after the start.
Of 23 observational studies under Peritonitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 43 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Apr 2028 → Dec 2029 and completion Apr 2028 → Dec 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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IRCCS San Raffaele Roma