Skip to main content
OpenTrials
Completed

NCT Number: NCT06426745

Split-dose Versus Single-dose Bowel Preparation for Colonoscopy

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing elective colonoscopy

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

Treatment and study plan

bowel preparation

Procedure

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

Other names: colonoscopy

Primary outcomes

  1. colon cleansing

    Time frame: 2 hours before Bowel Preparation

    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 .

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.