Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial.


Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
06 2019
Historique:
received: 11 07 2018
revised: 25 11 2018
accepted: 16 12 2018
pubmed: 20 1 2019
medline: 30 1 2020
entrez: 20 1 2019
Statut: ppublish

Résumé

Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing. to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen. Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing. Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment. The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).

Sections du résumé

BACKGROUND
Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing.
AIMS
to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen.
METHODS
Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing.
RESULTS
Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment.
CONCLUSIONS
The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).

Identifiants

pubmed: 30658942
pii: S1590-8658(18)31440-3
doi: 10.1016/j.dld.2018.12.012
pii:
doi:

Substances chimiques

Cathartics 0
Bisacodyl 10X0709Y6I
Citric Acid 2968PHW8QP
Polyethylene Glycols 3WJQ0SDW1A
Simethicone 8050-81-5

Banques de données

ClinicalTrials.gov
['NCT03146052']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

837-842

Informations de copyright

Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Auteurs

Paolo Andreozzi (P)

Gastroenterology Unit, Marcianise Hospital, ASL Caserta, Italy.

Germana De Nucci (G)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Cristina Bezzio (C)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Ilaria Arena (I)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Massimo Devani (M)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Enzo Mandelli (E)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Daniela Morganti (D)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Barbara Omazzi (B)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Raffaella Reati (R)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Davide Redaelli (D)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Simone Saibeni (S)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy.

Gianpiero Manes (G)

Department of Gastroenterology, Rho and Garbagnate Milanese Hospital, ASST Rhodense, Milano, Italy. Electronic address: gimanes@tin.it.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH