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

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical, radiological, intraoperative visual, and surgeon-reported factors associated with the intraoperative decision to perform primary anastomosis versus Hartmann's procedure
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of primary anastomosis versus Hartmann's procedure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

IRCCS San Raffaele Roma

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. maj 2026

Primær færdiggørelse (Anslået)

30. april 2028

Studieafslutning (Anslået)

30. april 2028

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AIDE470/SR/26

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Peritonitis

Kliniske forsøg med Primary anastomosis

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