Complicated DiverticulitisAIDE/OBS/2025NCT07651072
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
An observational study of Complicated Diverticulitis and Acute Diverticulitis, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Diverticulitis, Acute Diverticulitis, Peritonitis
- What is being tested?
- Primary anastomosis and Hartmann's procedure
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 15 May 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Enrolling by invitation
eCampus university
Novedrate, Como
- Recruiting
IRCCS San Raffaele Roma
Roma, RM, 00166
Fabrizio Vecchio, +39-06-52253767, fabrizio.vecchio@sanraffaele.it
About this study
Official title: AIDE: a Multicenter Observational Study to Support the Decision Between Anastomosis and Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
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.
Read the detailed description
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.
- Being tested
- Primary anastomosis, Hartmann's procedure
- Keywords
- Perforated diverticulitis, Emergency surgery, Non-elective surgery, Primary anastomosis, Hartmann's procedure, Intraoperative decision-making, Artificial intelligence, Computer vision, Surgical video analysis, Multimodal dataset
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary anastomosisProcedure or surgery
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.
Hartmann's procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Anastomosis Group | Patients undergoing sigmoid resection with primary anastomosis, with or without diverting stoma, for complicated acute diverticulitis in a non-elective surgical setting. Receives: Procedure: Primary anastomosis | |
| Hartmann's Procedure Group | Patients undergoing sigmoid resection with end colostomy and rectal stump closure for complicated acute diverticulitis in a non-elective surgical setting. Receives: Procedure: Hartmann's procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.
Secondary outcomes (8)
Rate of primary anastomosis versus Hartmann's procedure
Proportion of patients undergoing primary anastomosis, with or without diverting stoma, compared with Hartmann's procedure.
Measured: 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.
Measured: 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.
Measured: From the date of surgery until 30 postoperative days.
Postoperative morbidity
Rate of postoperative complications after non-elective surgery for complicated diverticulitis.
Measured: Assessed during index hospitalization and up to 30 postoperative days.
Stoma creation rate
Proportion of patients receiving a stoma during the index operation.
Measured: Assessed intraoperatively during the index emergency surgical procedure.
Length of hospital stay
Duration of hospital stay after the index operation.
Measured: From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.
Mortality
All-cause postoperative mortality
Measured: 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.
Measured: From study initiation until completion of participant enrollment and database closure, estimated up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- World Society of Emergency Surgery
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651072
- Sponsor's protocol ID
- AIDE470/SR/26
- Acronym
- AIDE/OBS/2025
- Status last verified
- Nov 2026
- First submitted
- 25 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDE: a Multicenter Observational Study to Support the Decision Between Anastomosis and Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
- ClinicalTrials.gov ID
- NCT07651072
- Acronym / sponsor ID
- AIDE/OBS/2025 / AIDE470/SR/26
- Keywords
- Perforated diverticulitis, Emergency surgery, Non-elective surgery, Primary anastomosis, Hartmann's procedure, Intraoperative decision-making, Artificial intelligence, Computer vision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- World Society of Emergency Surgery
- Study start
- 15 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Anastomosis Group | – | Procedure: Primary anastomosisPatients undergoing sigmoid resection with primary anastomosis, with or without diverting stoma, for complicated acute diverticulitis in a non-elective surgical setting. |
| Hartmann's Procedure Group | – | Procedure: Hartmann's procedurePatients undergoing sigmoid resection with end colostomy and rectal stump closure for complicated acute diverticulitis in a non-elective surgical setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary anastomosisObserved 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 or surgery | Primary Anastomosis Group |
| Hartmann's procedureObserved 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. | Procedure or surgery | Hartmann's Procedure Group |
Primary outcome
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Time frame: Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.
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.
8 secondary outcomes
Rate of primary anastomosis versus Hartmann's procedure
Time frame: Assessed intraoperatively during the index emergency surgical procedure.
Completeness of standardized intraoperative visual data acquisition
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
Time frame: From the date of surgery until 30 postoperative days.
Postoperative morbidity
Time frame: Assessed during index hospitalization and up to 30 postoperative days.
Stoma creation rate
Time frame: Assessed intraoperatively during the index emergency surgical procedure.
Length of hospital stay
Time frame: From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.
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
Time frame: From study initiation until completion of participant enrollment and database closure, estimated up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Diverticulitis and Acute Diverticulitis, run by IRCCS San Raffaele Roma at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belinda De Simone, MD (+33665787872, ariesproject2023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure (time frame: Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.