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NCT Number: NCT07651072

AIDE: Decision Support for Anastomosis or 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASL Romagna

Cesena, FC, Italy

Location contact

Belinda De Simone, MD

CONTACT

[email protected]

0652253440 ext. +39

Belinda De Simone, md

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of primary anastomosis versus Hartmann's procedure

    Time frame: Assessed intraoperatively during the index emergency surgical procedure.

    Proportion of patients undergoing primary anastomosis, with or without diverting stoma, compared with Hartmann's procedure.

  2. 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.

    Proportion of cases with uploaded anonymized intraoperative images or videos according to the predefined study phases.

  3. Anastomotic leak rate

    Time frame: From the date of surgery until 30 postoperative days.

    Rate of clinically or radiologically diagnosed anastomotic leak among patients receiving primary anastomosis.

  4. Postoperative morbidity

    Time frame: Assessed during index hospitalization and up to 30 postoperative days.

    Rate of postoperative complications after non-elective surgery for complicated diverticulitis.

  5. Stoma creation rate

    Time frame: Assessed intraoperatively during the index emergency surgical procedure.

    Proportion of patients receiving a stoma during the index operation.

  6. Length of hospital stay

    Time frame: From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.

    Duration of hospital stay after the index operation.

  7. Mortality

    Time frame: From the date of surgery up to 30 postoperative days.

    All-cause postoperative mortality

  8. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Belinda De Simone, MD

CONTACT

[email protected]

+33665787872

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

AIDE: a Multicenter Observational Study to Support the Decision Between Anastomosis and Colostomy in Emergency Surgery for Complicated Acute Diverticulitis

Acronym: AIDE/OBS/2025

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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