Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Quebec
-
Montreal, Quebec, Canada, H3G1A4
- McGill University Health Centre
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Sherbrooke, Quebec, Canada, J1G 2E8
- Centre Hospitalier Universitaire de Sherbrooke
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Efficacy
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tolerability
Délai: 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
Délai: 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
Délai: Following colonoscopy
|
What is the cecal/ileal intubation rate for colonoscopies performed in hospitalized patients?
|
Following colonoscopy
|
|
Polyp detection rate
Délai: Following colonosopy
|
What is the polyp detection rate for colonoscopies performed in hospitalized patients?
|
Following colonosopy
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GEN 13-148
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