Clinical trial NCT02956057
Conditions: Colonoscopy
Sponsor: Tomas Bata Hospital, Czech Republic
Start date: 2016-11-12; Completion date: 2017-08-17
Enrollment: 1044 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

Detailed description:
To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.

Arms: arm 1: Polyethylene glycols single dose a day before colonoscopy arm 2: Polyethylene glycols split dose arm 3: Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy arm 4: Natrium picosulfate/ Magnesium citrate split dose arm 5: Polyethylene glycol / Ascorbic acid single dose day before colonoscopy arm 6: Polyethylene glycol / Ascorbic acid split dose
Interventions: intervention 1: Polyethylene Glycols intervention 2: Natrium picosulfate / Magnesium citrate intervention 3: Polyethylene glycol / Ascorbic acid
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_SAP_000.pdf: 
Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy 
 NCT02956057 
 
3.1.2016 
 
 


 
A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy. 
Methods This was a prospective, randomized, endoscopist-blinded, multicentre study. Outpatients 
referred to colonoscopy in the endoscopy departments of University Hospital in Brno, Prague and 
Bata Regional Hospital in Zlin were enrolled. Exclusion criteria were as follows: ileus or suspected 
bowel obstruction, gastroparesis, active bowel inflammation or bleeding, any presence of serious 
medical conditions, history of bowel surgery. Informed consent was obtained from all participants 
and study was approved by the ethics committee. The study was registered at 
https://clinicaltrials.gov (NCT02956057). The quality of bowel preparation was considered as the 
primary endpoint. Secondary endpoints included preparation tolerability, occurence of complaints 
during preparation and the impact of additional factors (product type, age, sex, constipation, 
ingested volume, BMI, diabetes) on the quality of the preparation and tolerability. The SING_PEG 
group was prepared using PEG (Fortrans ™ plv. sol., Ipsen Pharma) in the afternoon before 
colonoscopy (4 sachets + 4L of water), split group (SPL_PEG) used 3 sachets + 3 L water in the 
afternoon and 1 sachet + 1L water in the morning. SING_SPMC group used 2 sachets of SPMC 
(Picoprep™ plv. sol., Ferring Pharmaceuticals ) in the afternoon before colonoscopy followed by 2 L of 
a water-based drink. SPL-SPMC group used SPMC in the afternoon (1 sachet + 1L of a drink ) and the 
same dose in the morning before colonoscopy. SING-PEGA group used 2 sachets of PEGA(Moviprep 
™ plv. sol, Norgine Ltd.) + 1 L of drink the afternoon before colonoscopy. SPL-PEGA prepared subjects 
ingested 1 sachet of PEGA + 1 L liquid in the afternoon and the same dose in the morning. Patients 
were instructed to be on a low-residue diet for three days before the colonoscopy. All the 
colonoscopy procedures were performed between 7:30 AM and 13:00 PM. The bowel preparation 
was assessed blindly using the Aronchick scale. Tolerability of the preparation was assessed using a 5-
point visual analogue scale (1-excellent, 5-very poor). The amount of ingested fluid during 
preparation, presence of nausea, vomiting, abdominal pain, bloating and incontinence during 
preparation and demographic data was recorded . The study authors had planned to enroll 174 
patients in each group to provide 80% power to detect a 15% difference. The patients were 
randomized prospectively using a software, with 1:1 ratio between single and splitdose preparations 
for each laxative. Significance of differences was tested by the Kruskal-Wallis test with the Bonferroni 
correction. Association between categorical variables was assessed using the Fisher exact test. An 
multivariate logistic regression model was applied to measure the association of the baseline 
characteristics with quality or tolerability criteria. The level of statistical significance was 0.05 in all 
analyses.