AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis (AIDE/OBS/2025)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Belinda De Simone, MD
- Número de teléfono: +33665787872
- Correo electrónico: ariesproject2023@gmail.com
Ubicaciones de estudio
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FC
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Cesena, FC, Italia
- ASL Romagna
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Investigador principal:
- Belinda De Simone, md
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Contacto:
- Belinda De Simone, MD
- Número de teléfono: +39 0652253440
- Correo electrónico: ariesproject2023@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Periodo de tiempo: Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.
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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.
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Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of primary anastomosis versus Hartmann's procedure
Periodo de tiempo: Assessed intraoperatively during the index emergency surgical procedure.
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Proportion of patients undergoing primary anastomosis, with or without diverting stoma, compared with Hartmann's procedure.
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Assessed intraoperatively during the index emergency surgical procedure.
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Completeness of standardized intraoperative visual data acquisition
Periodo de tiempo: 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.
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Proportion of cases with uploaded anonymized intraoperative images or videos according to the predefined study phases.
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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.
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Anastomotic leak rate
Periodo de tiempo: From the date of surgery until 30 postoperative days.
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Rate of clinically or radiologically diagnosed anastomotic leak among patients receiving primary anastomosis.
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From the date of surgery until 30 postoperative days.
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Postoperative morbidity
Periodo de tiempo: Assessed during index hospitalization and up to 30 postoperative days.
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Rate of postoperative complications after non-elective surgery for complicated diverticulitis.
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Assessed during index hospitalization and up to 30 postoperative days.
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Stoma creation rate
Periodo de tiempo: Assessed intraoperatively during the index emergency surgical procedure.
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Proportion of patients receiving a stoma during the index operation.
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Assessed intraoperatively during the index emergency surgical procedure.
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Length of hospital stay
Periodo de tiempo: From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.
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Duration of hospital stay after the index operation.
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From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.
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Mortality
Periodo de tiempo: From the date of surgery up to 30 postoperative days.
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All-cause postoperative mortality
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From the date of surgery up to 30 postoperative days.
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Proportion of enrolled cases with complete standardized clinical and intraoperative visual datasets
Periodo de tiempo: From study initiation until completion of participant enrollment and database closure, estimated up to 24 months.
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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. |
From study initiation until completion of participant enrollment and database closure, estimated up to 24 months.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AIDE470/SR/26
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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