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AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis (AIDE/OBS/2025)

10. června 2026 aktualizováno: IRCCS San Raffaele Roma

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

150

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Itálie
    • FC
      • Cesena, FC, Itálie
        • ASL Romagna
        • Vrchní vyšetřovatel:
          • Belinda De Simone, md
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Postup: Primary anastomosis
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 Group
Patients undergoing sigmoid resection with end colostomy and rectal stump closure for complicated acute diverticulitis in a non-elective surgical setting.
Postup: Hartmann's 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Časové okno: 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.
Assessed intraoperatively during the index emergency surgical procedure and recorded at completion of operative case data entry.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of primary anastomosis versus Hartmann's procedure
Časové okno: Assessed intraoperatively during the index emergency surgical procedure.
Proportion of patients undergoing primary anastomosis, with or without diverting stoma, compared with Hartmann's procedure.
Assessed intraoperatively during the index emergency surgical procedure.
Completeness of standardized intraoperative visual data acquisition
Časové okno: 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.
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
Časové okno: From the date of surgery until 30 postoperative days.
Rate of clinically or radiologically diagnosed anastomotic leak among patients receiving primary anastomosis.
From the date of surgery until 30 postoperative days.
Postoperative morbidity
Časové okno: Assessed during index hospitalization and up to 30 postoperative days.
Rate of postoperative complications after non-elective surgery for complicated diverticulitis.
Assessed during index hospitalization and up to 30 postoperative days.
Stoma creation rate
Časové okno: Assessed intraoperatively during the index emergency surgical procedure.
Proportion of patients receiving a stoma during the index operation.
Assessed intraoperatively during the index emergency surgical procedure.
Length of hospital stay
Časové okno: 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.
From the date of the index emergency surgical procedure until hospital discharge, assessed up to 90 days.
Mortality
Časové okno: From the date of surgery up to 30 postoperative days.
All-cause postoperative mortality
From the date of surgery up to 30 postoperative days.
Proportion of enrolled cases with complete standardized clinical and intraoperative visual datasets
Časové okno: 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.
From study initiation until completion of participant enrollment and database closure, estimated up to 24 months.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

IRCCS San Raffaele Roma

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

31. května 2026

Primární dokončení (Odhadovaný)

30. dubna 2028

Dokončení studie (Odhadovaný)

30. dubna 2028

Termíny zápisu do studia

První předloženo

25. května 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

16. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

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