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

Polyps Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146052
• Other study ID #: 165-032017
• Status: Completed
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 8, 2017
• Start date: March 27, 2017
• Est. completion date: May 5, 2017

Study information

• Verified date: May 2017
• Source: ASST Rhodense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Preparation
• Polyps

Intervention

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

Locations

Country	Name	City	State
Italy	ASST Rhodense	Garbagnate Milanese	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
ASST Rhodense

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adenoma detection rate	rate of patients with at least one adenoma	2 days
Secondary	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
Secondary	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
Secondary	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