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

Comparison Between Asymmetric (Low Dose In The Morning) And Standard Split-Dose Regimen Of Polyethylene Glycol Plus Bisacodyl For Bowel Preparation For Screening And Surveillance Colonoscopy: A Randomized Non-Inferiority Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Polyps; Colon Preparation
• Intervention / Treatment: Drug: PEG-4000 added with citrates and simethicone (PEG-CS) plus Bisacodyl

Detailed Description

Prospective, randomized, single-blind, non-inferiority trial in adult patients undergoing screening or surveillance colonoscopy. Eligible participants were randomly assigned, according to a computer-generated list with an allocation ratio of 1:1, to receive either asymmetric or symmetric split-dose regimen of a low-volume preparation by investigators who were not involved in the enrolment process. Detailed written instructions were administered to all patients who accepted to participate. A low-fiber diet was prescribed three day before colonoscopy; participants in both groups were instructed to have a light lunch on the day before the colonoscopy and only clear liquid were allowed on the day of the exam. All endoscopic procedures were scheduled between 9:00 AM and 1:00 PM.

The preparation used in the study is a combination of a 2 L sulphate-free iso-osmotic formulation of of PEG-4000 added with citrates and simethicone (PEG-CS) (Lovol-esse; AlfaWassermann, Bologna, Italy. Kit contains 4 pouches, each containing 64.5gr of PEG, to be dissolved in 2 L of water.), and bisacodyl 5 mg tablets (Lovodyl; Alfa-Wassermann, Bologna, Italy).

All subjects were instructed to take 4 bisacodyl tablets at 4:00 PM on the day before the procedure. Subjects allocated to the asymmetric split-dose regimen group were invited to consume at 6:00 PM on the evening before the colonoscopy 3 sachets of PEG-CS in 1,5 L of water in a range from 90 to 120 minutes (about 250 mL every 15 min) and 4 hours before the scheduled procedure 1 sachets in 0,5 L of water in a range from 15 to 30 minutes. Subjects allocated to the symmetric split-dose regimen group were invited to consume at 6:00 PM on the evening before the colonoscopy 2 sachets of PEG-CS in 1 L of water in a range from 60 to 90 minutes and 5 hours before the scheduled procedure 2 sachets in 1 L of water in a range from 60 to 90 minutes.

Unblinded investigators collected demographic and clinical data with medical history. All patients filled in a nurse-administered questionnaire to assess compliance, tolerability and safety of bowel preparation.

Blinded experencied endoscopists performed endoscopic procedure in accordance with colonoscopy quality practice. Data on bowel cleansing (evaluated by using Boston Bowel Preparation Scale), endoscopic procedures and findings (i.e. cancer, polyps, diverticula) were collected.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Garbagnate Milanese, Lombardia, Italy, 20020
      • ASST Rhodense

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients scheduled as outpatient for screening or surveillance colonoscopy

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asymmetric split dose preparation; 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; PEG-4000 added with citrates and simethicone (PEG-CS) (Kit contains 4 pouches, each containing 64.5gr of PEG) and bisacodyl 5 mg tablets
Active Comparator: Symmetric split dose preparation; 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; PEG-4000 added with citrates and simethicone (PEG-CS) (Kit contains 4 pouches, each containing 64.5gr of PEG) and bisacodyl 5 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	rate of patients with at least one adenoma	2 days
Rate of the occurrence of adverse events	Rate of the occurrence of adverse events (bad taste in mouth, gastric fullness, nausea or vomiting, bloating, abdominal pain, headache)	2 days
Compliance	Compliance was assessed by the amount of intake of study agents using a 3-point scale: 1 (100% intake), 2 (≥ 75% intake), and 3 (< 75% intake).	2 days
Tolerability	Tolerability was evaluated assessing how patient finds tolerable the bowel preparation by using a 4-point scale: 1 (Easy), 2 (Acceptable), 3 (Somewhat difficult), 4 (Very difficult).	2 days

Collaborators and Investigators

• Sponsor: ASST Rhodense
• Investigators: Principal Investigator: Gianpiero Manes, ASST Rhodense, Garbagnate Milanese, Lombardia, Italy, 20020

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): May 5, 2017
• Study Completion (Actual): May 5, 2017

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Colon cleansing
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Antifoaming Agents; Emollients; Cathartics; Laxatives; Simethicone; Bisacodyl
• Other Study ID Numbers: 165-032017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No