Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy

22. februar 2021 opdateret af: Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre

Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. The ideal bowel preparation formulation should be able to completely clean the bowel, without leaving solid or liquid residues, and without modifying the mucosal appearance.

Bowel preparation may be administered in hospitalised patients or in the ER. Patients have less control on their environment and the intake of the bowel preparation. For example, there may be a delay in pharmacy delivery or inadequate supervision by the treating personnel. Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple studies have identified hospitalization status as an independent risk factor for poor bowel preparation.

The objective of this study is to access which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

82

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • McGill University Health Centre
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Centre Hospitalier Universitaire de Sherbrooke

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

Beskrivelse

Inclusion Criteria

  • 18 years or older
  • Be able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
  • Have a recognised indication for full colonoscopy after evaluation by a gastroenterologist or surgeon
  • Be hospitalized or in the ED of a participating hospital center.
  • Need to receive a bowel preparation during hospitalization or the ED stay.
  • Be able to complete the follow-up patient response form in French or English

Exclusion Criteria:

  • Patient refusal
  • A suspected or diagnosed bowel obstruction
  • A toxic megacolon
  • Ileus
  • Decompensated heart failure
  • Severe acute renal failure
  • Severe electrolyte imbalance
  • Previous bowel preparation in the last 7 days
  • Pregnancy
  • Time of randomization before 9h00 or after 22h00

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PEG electrolytes 2L/2L split dose
Medicin: PEG/electrolytes 2L/2L split dose
Polyethylene glycol 17gm X 4 At 18h00 the day prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes On the day of the procedure, 4-5 hours prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes
Aktiv komparator: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose
Medicin: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose

Bisacodyl 15 mg x 3

At 14h00 the day prior the endoscopic procedure: take 3 tablets of Bisacodyl ER (15 mg) orally then 5 hr later:

PEG/electrolytes 1L/1L Polyethylene glycol 17gm Dilute one sachet of Polyethylene glycol 17gm in 1 L of water Start drinking at around 19h00 the night prior the colonoscopy Drink 240 ml every 10 minutes The day of the colonoscopy. At (4 hrs prior the procedure). Dilute on sachet of PEG and drink 240 ml every 10 minutes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy
Tidsramme: following colonoscopy
Which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
following colonoscopy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tolerability
Tidsramme: Before colonoscopy
A questionnaire will be used to assess which is the most tolerable and acceptable to patients between the two bowel preparation regimens
Before colonoscopy
Clinical quality standards
Tidsramme: After colonoscopy
Does the bowel preparation given prior to in-hospital colonoscopy result in an excellent or good preparation rate that falls within the required clinical quality standards?
After colonoscopy
Cecal/ileal intubation rate
Tidsramme: Following colonoscopy
What is the cecal/ileal intubation rate for colonoscopies performed in hospitalized patients?
Following colonoscopy
Polyp detection rate
Tidsramme: Following colonosopy
What is the polyp detection rate for colonoscopies performed in hospitalized patients?
Following colonosopy

Samarbejdspartnere og efterforskere

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

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

1. august 2015

Primær færdiggørelse (Faktiske)

1. januar 2020

Studieafslutning (Faktiske)

1. januar 2020

Datoer for studieregistrering

Først indsendt

26. januar 2014

Først indsendt, der opfyldte QC-kriterier

17. april 2014

Først opslået (Skøn)

21. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GEN 13-148

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Indlagte patienter

Kliniske forsøg med PEG/electrolytes 2L/2L split dose

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bangladesh

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner