Split-dose Versus Single-dose Bowel Preparation for Colonoscopy

NCT ID: NCT06426745

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-12-01

Brief Summary

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

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.

Conditions

Colonic Cancer; Colonic Polyp; IBS - Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Split-dose bowel preparation

About 90 participants underwent Split-dose bowel preparation for colonoscopy

Group Type: EXPERIMENTAL

Bowel preparation

Intervention Type: PROCEDURE

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

single-dose bowel preparation

About 90 participants underwent single-dose bowel preparation for colonoscopy

Group Type: EXPERIMENTAL

Bowel preparation

Intervention Type: PROCEDURE

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

Interventions

Bowel preparation

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

Intervention Type: PROCEDURE

Other Intervention Names

colonoscopy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seham Mohammad Abd-AlAdl Seif, Professor

Role: STUDY_CHAIR

Internal Medicine Hepatology and Gastroenterology Faculty of Medicine - Mansoura University

Hany Shabana, M.D

Role: STUDY_DIRECTOR

Hepatology and Gastroenterology Faculty of Medicine - Mansoura University

Locations

Mansoura university Hospital

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

PEG solution

Identifier Type: -

Identifier Source: org_study_id