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

NCT07651072 | Not Yet Recruiting

• 1 other identifier: AIDE470/SR/26
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complicated Diverticulitis; Acute Diverticulitis; Peritonitis; Perforated Diverticulitis

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Assessed intraoperatively during the index emergency surgical procedure.

• Completeness of standardized intraoperative visual data acquisition

  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

  From the date of surgery until 30 postoperative days.

• Postoperative morbidity

  Assessed during index hospitalization and up to 30 postoperative days.

• Stoma creation rate

  Assessed intraoperatively during the index emergency surgical procedure.

Study Arms (2)

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.

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.

Procedure: Hartmann's procedure

Interventions

Primary anastomosis 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.

Primary Anastomosis Group

Hartmann's procedure 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.

Hartmann's Procedure Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

ASL Romagna

Cesena, FC, Italy

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Central Study Contacts

Belinda De Simone, MD

CONTACT

+33665787872; ariesproject2023@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 16, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

IT (1)