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CompletedNCT06426745Updated May 23, 2024

Split-dose Versus Single-dose Bowel Preparation for Colonoscopy

An interventional study of Bowel preparation in Colonic Cancer, Colonic Polyp and IBS - Irritable Bowel Syndrome, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Nov 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer, IBD, polyps, and other conditions.

Read the detailed description

Colonic cancers are a major concern in the Middle East and the world in general, and every institute has attempted to initiate various clinical and investigatory procedures to detect the disease early in its development. From 2005 till 2010 an audit conducted at the Royal Liverpool University revealed that out of 8910 colonoscopies, 693 were incomplete (7.8%), and for 25% of failure was because of inadequate bowel preparation.

An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients. The polyethylene glycol (PEG) solution, an isosmotic non-absorbable polymer, is generally used for bowel preparation, because of its safety, effectiveness, and good tolerability. Quality of bowel cleansing depends not only on the formula used, but the preparation regimen also plays a role. Split dosing of the laxative offers, in general, better cleansing than a single dose preparation.

A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation.

Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose, in terms of adequate bowel preparation and polyp detection.

On the other hand , a large randomized trial of PEG regimens show, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose. Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated, and acceptable bowel preparation for colonoscopy.

A same-day dose of bowel cleanser has several benefits compared with split-dose or previous-day dose: the fasting time is shorter and there is no sleep disturbance, which can be associated with split-dose or previous-day regimen.

02

Conditions studied

  • Colonic Cancer
  • Colonic Polyp
  • IBS - Irritable Bowel Syndrome
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 180 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients undergoing elective colonoscopy

Exclusion criteria

Exclusion Criteria:

  • Presence of sever renal impairment. (Creatinine clearance \< 30 ml/min or patient on hemodialysis).
  • Sever congestive heart failure (NHYA III or IV).
  • Pregnant woman.
  • History of bowel obstruction or resection.
  • Known allergies to polyethylene glycol.
  • Refusal of consent for the study.
  • Signs of liver cell failure as ascites and hepatic encephalopathy.
  • Electrolytes disturbances
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Split-dose bowel preparation

    About 90 participants underwent Split-dose bowel preparation for colonoscopy

    Procedure: Bowel preparation

  • Experimental
    single-dose bowel preparation

    About 90 participants underwent single-dose bowel preparation for colonoscopy

    Procedure: Bowel preparation

Interventions

  • ProcedureBowel preparation

    to compare bowel cleanliness, compliance, tolerability, and patient satisfaction of a single regimen versus a split regimen for colonoscopy.

    Also known as: colonoscopy

06

What researchers measure

Primary outcomes

  1. colon cleansing

    to compare the efficacy of split-dose versus single morning administration of PEG solution for colon cleansing in patient undergoing colonoscopy using Boston Bowel Preparation Scale , and to assess the optimal preparation- to-colonoscopy (PC) interval .

    Time frame: 2 hours before Bowel Preparation

07

Study locations

1 site
  • Mansoura university Hospital
    Mansoura, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06426745
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
May 23, 2024
Start date
Nov 1, 2022
Primary completion
Oct 25, 2023
Completion
Dec 1, 2023
Last update
May 23, 2024

Study contacts

Seham Mohammad Abd-AlAdl Seif, Professor
study chair · Internal Medicine Hepatology and Gastroenterology Faculty of Medicine - Mansoura University
Hany Shabana, M.D
study director · Hepatology and Gastroenterology Faculty of Medicine - Mansoura University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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