Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

150

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Italien
    • FC
      • Cesena, FC, Italien
        • ASL Romagna
        • Hauptermittler:
          • Belinda De Simone, md
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Verfahren: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of primary anastomosis versus Hartmann's procedure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

IRCCS San Raffaele Roma

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

31. Mai 2026

Primärer Abschluss (Geschätzt)

30. April 2028

Studienabschluss (Geschätzt)

30. April 2028

Studienanmeldedaten

Zuerst eingereicht

25. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AIDE470/SR/26

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Bauchfellentzündung

Klinische Studien zur Primary anastomosis

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Argentina

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren