Randomised clinical trial

Low-volume bowel preparation for colonoscopy - A comparison between two different PEG-based formulations

A. Repici, R. Cestari, V. Annese, G. Biscaglia, E. Vitetta, L. Minelli, G. Trallori, S. Orselli, A. Andriulli, C. Hassan

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Background Low-volume bowel preparations with polyethylene glycol (PEG) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso-osmotic sulphate-free formulation of PEG-Citrate-Simethicone (PEG-CS) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG-CS with bisacodyl vs. PEG-Ascorbate (PEG-ASC) in adult out-patients undergoing colonoscopy. Methods Randomised, observer-blind, parallel group study in adult out-patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 2-4 tablets of 5 mg bisacodyl at 16:00 hours and 2 L of PEG-CS at 20:00 hours or 2 L of PEG-ASC plus 1 L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (≥6 scores were considered as 'clinical success'), and mucosal visibility according to a 3-point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG-CS and bisacodyl (n = 204, male patient 48%, mean age 59.1 years) or PEG-ASC (n = 204, male patient 51%, age 59.4 years). In the planned per-protocol analysis, the rate of successful preparation was 79.1% following PEG-CS with bisacodyl, and 70% following PEG-ASC (P <0.05). Mucosal visibility was evaluated as optimal in 56.1% in the PEG-CS and bisacodyl and 46.3% in the PEG-ASC group (P <0.05). There were no serious adverse events (AE) in each of the two experimental groups. Two subjects in the PEG-ASC group discontinued the study because of AE. Conclusions Polyethylene glycol-Citrate-Simethicone in combination with bisacodyl was more effective for bowel cleansing than PEG-ASC for out-patient colonoscopy. Tolerability, safety, acceptability and compliance of the two low-volume bowel preparations were similar.

Original languageEnglish
Pages (from-to)717-724
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Volume36
Issue number8
DOIs
Publication statusPublished - Oct 2012

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Colonoscopy
Randomized Controlled Trials
Bisacodyl
Simethicone
Outpatients
Citric Acid
Compliance
Tablets
Sulfates

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Randomised clinical trial : Low-volume bowel preparation for colonoscopy - A comparison between two different PEG-based formulations. / Repici, A.; Cestari, R.; Annese, V.; Biscaglia, G.; Vitetta, E.; Minelli, L.; Trallori, G.; Orselli, S.; Andriulli, A.; Hassan, C.

In: Alimentary Pharmacology and Therapeutics, Vol. 36, No. 8, 10.2012, p. 717-724.

Research output: Contribution to journalArticle

Repici, A. ; Cestari, R. ; Annese, V. ; Biscaglia, G. ; Vitetta, E. ; Minelli, L. ; Trallori, G. ; Orselli, S. ; Andriulli, A. ; Hassan, C. / Randomised clinical trial : Low-volume bowel preparation for colonoscopy - A comparison between two different PEG-based formulations. In: Alimentary Pharmacology and Therapeutics. 2012 ; Vol. 36, No. 8. pp. 717-724.
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abstract = "Background Low-volume bowel preparations with polyethylene glycol (PEG) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso-osmotic sulphate-free formulation of PEG-Citrate-Simethicone (PEG-CS) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG-CS with bisacodyl vs. PEG-Ascorbate (PEG-ASC) in adult out-patients undergoing colonoscopy. Methods Randomised, observer-blind, parallel group study in adult out-patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 2-4 tablets of 5 mg bisacodyl at 16:00 hours and 2 L of PEG-CS at 20:00 hours or 2 L of PEG-ASC plus 1 L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (≥6 scores were considered as 'clinical success'), and mucosal visibility according to a 3-point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG-CS and bisacodyl (n = 204, male patient 48{\%}, mean age 59.1 years) or PEG-ASC (n = 204, male patient 51{\%}, age 59.4 years). In the planned per-protocol analysis, the rate of successful preparation was 79.1{\%} following PEG-CS with bisacodyl, and 70{\%} following PEG-ASC (P <0.05). Mucosal visibility was evaluated as optimal in 56.1{\%} in the PEG-CS and bisacodyl and 46.3{\%} in the PEG-ASC group (P <0.05). There were no serious adverse events (AE) in each of the two experimental groups. Two subjects in the PEG-ASC group discontinued the study because of AE. Conclusions Polyethylene glycol-Citrate-Simethicone in combination with bisacodyl was more effective for bowel cleansing than PEG-ASC for out-patient colonoscopy. Tolerability, safety, acceptability and compliance of the two low-volume bowel preparations were similar.",
author = "A. Repici and R. Cestari and V. Annese and G. Biscaglia and E. Vitetta and L. Minelli and G. Trallori and S. Orselli and A. Andriulli and C. Hassan",
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T2 - Low-volume bowel preparation for colonoscopy - A comparison between two different PEG-based formulations

AU - Repici, A.

AU - Cestari, R.

AU - Annese, V.

AU - Biscaglia, G.

AU - Vitetta, E.

AU - Minelli, L.

AU - Trallori, G.

AU - Orselli, S.

AU - Andriulli, A.

AU - Hassan, C.

PY - 2012/10

Y1 - 2012/10

N2 - Background Low-volume bowel preparations with polyethylene glycol (PEG) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso-osmotic sulphate-free formulation of PEG-Citrate-Simethicone (PEG-CS) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG-CS with bisacodyl vs. PEG-Ascorbate (PEG-ASC) in adult out-patients undergoing colonoscopy. Methods Randomised, observer-blind, parallel group study in adult out-patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 2-4 tablets of 5 mg bisacodyl at 16:00 hours and 2 L of PEG-CS at 20:00 hours or 2 L of PEG-ASC plus 1 L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (≥6 scores were considered as 'clinical success'), and mucosal visibility according to a 3-point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG-CS and bisacodyl (n = 204, male patient 48%, mean age 59.1 years) or PEG-ASC (n = 204, male patient 51%, age 59.4 years). In the planned per-protocol analysis, the rate of successful preparation was 79.1% following PEG-CS with bisacodyl, and 70% following PEG-ASC (P <0.05). Mucosal visibility was evaluated as optimal in 56.1% in the PEG-CS and bisacodyl and 46.3% in the PEG-ASC group (P <0.05). There were no serious adverse events (AE) in each of the two experimental groups. Two subjects in the PEG-ASC group discontinued the study because of AE. Conclusions Polyethylene glycol-Citrate-Simethicone in combination with bisacodyl was more effective for bowel cleansing than PEG-ASC for out-patient colonoscopy. Tolerability, safety, acceptability and compliance of the two low-volume bowel preparations were similar.

AB - Background Low-volume bowel preparations with polyethylene glycol (PEG) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso-osmotic sulphate-free formulation of PEG-Citrate-Simethicone (PEG-CS) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG-CS with bisacodyl vs. PEG-Ascorbate (PEG-ASC) in adult out-patients undergoing colonoscopy. Methods Randomised, observer-blind, parallel group study in adult out-patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 2-4 tablets of 5 mg bisacodyl at 16:00 hours and 2 L of PEG-CS at 20:00 hours or 2 L of PEG-ASC plus 1 L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (≥6 scores were considered as 'clinical success'), and mucosal visibility according to a 3-point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG-CS and bisacodyl (n = 204, male patient 48%, mean age 59.1 years) or PEG-ASC (n = 204, male patient 51%, age 59.4 years). In the planned per-protocol analysis, the rate of successful preparation was 79.1% following PEG-CS with bisacodyl, and 70% following PEG-ASC (P <0.05). Mucosal visibility was evaluated as optimal in 56.1% in the PEG-CS and bisacodyl and 46.3% in the PEG-ASC group (P <0.05). There were no serious adverse events (AE) in each of the two experimental groups. Two subjects in the PEG-ASC group discontinued the study because of AE. Conclusions Polyethylene glycol-Citrate-Simethicone in combination with bisacodyl was more effective for bowel cleansing than PEG-ASC for out-patient colonoscopy. Tolerability, safety, acceptability and compliance of the two low-volume bowel preparations were similar.

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