Comparison Between Asymmetric And Standard Split-Dose Regimen For Bowel Preparation

NCT03146052 | Completed

• 1 other identifier: 165-032017
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to compare the efficacy for bowel cleansing of a split-dose regimen with a low morning dose of PEG solution (Asymmetric; 25% of the dose is given on the day of the procedure and 75% of the dose is given on the day before) with the standard split-dose regimen in patients undergoing screening and surveillance colonoscopy using a low volume bowel preparation (2L PEG-citrate-simethicone plus Bisacodyl). We enrolled consecutive outpatients undergoing screening and surveillance colonoscopy in a randomized, single-blind, non-inferiority clinical trial. Patients were randomly assigned to: group A, asymmetric split dose regimen (1,5 L of PEG + bisacodyl the day before and 0,5 L 4 hours before colonoscopy); group B, symmetric split dose regimen (1 L of PEG + bisacodyl the day before and 1 L 5 hours before colonoscopy). Primary endpoint was the proportion of adequate bowel cleansing. Moreover, all patients filled in a nurse-administered questionnaire assessing compliance, tolerability and safety of bowel preparation.

Conditions

Polyps; Colon Preparation

Keywords

Colon cleansing

Outcome Measures

Primary Outcomes (1)

• Quality of bowel prepreparation

  Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale. Each segment of the colon received a score from 0 to 3, and these segment scores were summed for a total BBPS score ranging from 0 to 9. The preparation was considered adequate when BBPS score was ≥ 6 with a score with at least 2 points in any segment

  2 days

Secondary Outcomes (4)

• Adenoma detection rate

  2 days

• Rate of the occurrence of adverse events

  2 days

• Compliance

  2 days

• Tolerability

  2 days

Study Arms (2)

Asymmetric split dose preparation

EXPERIMENTAL

75% of the dose is given on the day before of the procedure and 25% of the dose is given on the day of the procedure

Drug: PEG-4000 added with citrates and simethicone (PEG-CS) plus Bisacodyl

Symmetric split dose preparation

ACTIVE COMPARATOR

50% of the dose is given on the day before of the procedure and 50% of the dose is given on the day of the procedure

Drug: PEG-4000 added with citrates and simethicone (PEG-CS) plus Bisacodyl

Interventions

PEG-4000 added with citrates and simethicone (PEG-CS) plus Bisacodyl DRUG

PEG-4000 added with citrates and simethicone (PEG-CS) (Kit contains 4 pouches, each containing 64.5gr of PEG) and bisacodyl 5 mg tablets

Asymmetric split dose preparation; Symmetric split dose preparation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled as outpatient for screening or surveillance colonoscopy

You may not qualify if:

• Inpatients
• refusal of split dose regimen for bowel preparation
• previous history of colorectal resection
• severe cardiac disease
• advanced (stage IV and V) chronic kidney disease
• pregnancy; ileus
• suspected bowel obstruction or toxic megacolon
• known inflammatory bowel disease
• known or suspected allergy to PEG.

Sponsors & Collaborators

• ASST Rhodense: lead

Study Sites (1)

ASST Rhodense

Garbagnate Milanese, Lombardy, 20020, Italy

Location

Related Publications (1)

• Andreozzi P, De Nucci G, Bezzio C, Arena I, Devani M, Mandelli E, Morganti D, Omazzi B, Reati R, Redaelli D, Saibeni S, Manes G. Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial. Dig Liver Dis. 2019 Jun;51(6):837-842. doi: 10.1016/j.dld.2018.12.012. Epub 2018 Dec 28.

  PMID: 30658942 DERIVED

MeSH Terms

Conditions

Polyps

Interventions

Citrates; Simethicone

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Gianpiero Manes

  ASST Rhodense, Garbagnate Milanese, Lombardia, Italy, 20020

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded endoscopists performed endoscopic procedure and evaluated colon cleansing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Gastroenterology Unit

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: March 27, 2017
• Primary Completion: May 5, 2017
• Study Completion: May 5, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)