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Factors Related to a Persistent Inadequate Bowel Preparation for Colonoscopy (REPREP)

31. december 2020 opdateret af: Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Factors Related to a Persistent Inadequate Bowel Preparation After a Colonoscopy With Inadequate Colon Cleansing. An Observational Prospective Multicenter Study

Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again.

Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units.

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

  • Emergency regime
  • Inability to obtain consent
  • Refusal of the patient

Primary end-point:

Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model.

The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score <6 or a score <2 even in only one of the colic segments.

Secondary end-point:

• Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

407

Kontakter og lokationer

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

Studiesteder

    • BO
      • Bologna, BO, Italien, 40138
        • Rekruttering
        • UOC Gastroenterologia ed Endoscopia Digestiva
        • 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Outpatient and hospitalized adult patients, candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.

Beskrivelse

Inclusion Criteria:

  • Outpatients or hospitalized patients
  • adults
  • candidates for colonoscopy for any pathology, in the normal pathway of care, with the need to repeat the bowel preparation due to inadequate colon cleansing.

Exclusion Criteria:

  • Emergency regimen
  • Inability to obtain consent
  • Patient refusal

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
Study cohort

Inclusion criteria:

Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing.

Exclusion criteria:

  • Emergency regime
  • Inability to obtain consent
  • Refusal of the patient
A colonoscopy scheduled within the normal pathway of care will be performed. No interventions will be performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identification of factors related to persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.
Tidsramme: Outcome will be assessed during colonoscopy.
A logistic regression analysis will be run to identify such factors.
Outcome will be assessed during colonoscopy.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of persistent inadequate colon cleansing at repeat colonoscopy due to inadequate colon cleansing.
Tidsramme: Outcome will be assessed during colonoscopy.
The prevalence of inadequate colon cleansing at repeat colonoscopy will be assessed
Outcome will be assessed during colonoscopy.

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

1. november 2020

Primær færdiggørelse (Forventet)

1. maj 2021

Studieafslutning (Forventet)

1. juni 2021

Datoer for studieregistrering

Først indsendt

29. december 2020

Først indsendt, der opfyldte QC-kriterier

31. december 2020

Først opslået (Faktiske)

5. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • REPREP

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Colon sygdom

Kliniske forsøg med colonoscopy

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